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A Study to Compare the Press Fit Condylar (P.F.C.) Sigma Rotating-platform High-flexion (RP-F) Versus the Press Fit Condylar (P.F.C.) Sigma Rotating-platform (RP) Knee Implants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00733369
Recruitment Status : Terminated (This study was closed for the reason of slow recruitment with only 16% of the target subjects recruited over a 29 month period.)
First Posted : August 13, 2008
Results First Posted : August 26, 2014
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
DePuy International

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Knee Osteoarthritis
Interventions Device: PFC Sigma RP-F
Device: PFC Sigma RP
Enrollment 106
Recruitment Details 2 sites enrolled 106 knees in 98 subjects who were then randomized into 2 groups, 50 into the PFC Sigma RP-F group and 56 into the PFC Sigma RP group.
Pre-assignment Details Study protocol was designed and executed on using ‘knees’ as study units.
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Period Title: Overall Study
Started 50 56
Completed 40 47
Not Completed 10 9
Reason Not Completed
Lost to Follow-up             2             1
Adverse Event             4             4
Protocol Violation             4             4
Arm/Group Title PFC Sigma RP-F PFC Sigma RP Total
Hide Arm/Group Description

125 patients to be allocated to this arm according to blinding envelopes

PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing

125 patients to be allocated to this arm according to blinding envelopes

PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing

Total of all reporting groups
Overall Number of Baseline Participants 50 56 106
Hide Baseline Analysis Population Description
Study protocol was designed and executed on using ‘knees’ as study units. Out of 106 enrolled knees, 11 knees were removed from analysis for following reasons: 8 protocol violations [bilaterals accrued at site bilaterals not allowed; used 1st knee operated upon] (4 inv, 4 control); 2 ltfu (1 inv, 1 control); 1 missing outcome (1 inv, 0 control).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 56 participants 106 participants
65.2  (7.2) 66.3  (6.4) 65.8  (6.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 56 participants 106 participants
Female
30
  60.0%
42
  75.0%
72
  67.9%
Male
20
  40.0%
14
  25.0%
34
  32.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 56 participants 106 participants
Spain 48 52 100
United Kingdom 2 4 6
1.Primary Outcome
Title Change From Pre-op to 1 Year Range of Motion.
Hide Description Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
106 enrolled knees, 11 of which excluded from the analysis due to:{0 Deaths + 8 Protocol Violations(bilaterals accrued at site where bilateral not allowed, used first knee operated upon: 4 investigational &4 control) + 2 lost to follow up (1 Inv & 1 Contr) + 1 missing outcome (1 Inv & 0 Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 44 51
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
44 51
Mean (Standard Deviation)
Unit of Measure: Degrees
13.11  (14.89) 10.71  (14.38)
2.Secondary Outcome
Title To Compare the Change in KOOS Pain Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 3-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 44 51
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
44 51
Mean (Standard Deviation)
Unit of Measure: Points
39.7  (21.7) 46.5  (18.0)
3.Secondary Outcome
Title To Compare the Change in KOOS Pain Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
106 enrolled knees, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (Bilaterals accrued at site where bilaterals are not allowed, used 1st knee operated upon: 4 investigational&4control)+ 2 lost to follow up (1 Inv, 1 Contr)+ 1 missing outcome (0Inv, 1 Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 45 50
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
45 50
Mean (Standard Deviation)
Unit of Measure: Points
45.0  (20.5) 48.9  (19.4)
4.Secondary Outcome
Title To Compare the Change in KOOS Pain Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
106 enrolled knees, 15 of which excluded from analysis due to:{0 Deaths + 8 Protocol Violation (4 Inv, 4 Contr) + 4 Revisions (1 Inv, 3 Contr) + 3 Lost to follow up (2 Inv, 1 Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 43 48
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
43 48
Mean (Standard Deviation)
Unit of Measure: Points
43.3  (21.3) 47.8  (20.1)
5.Secondary Outcome
Title To Compare the Change in KOOS Pain Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
This study has been terminated early, therefore the 5 year data was not collected.
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title To Compare the Change in KOOS Symptoms Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 3-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 44 51
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
44 51
Mean (Standard Deviation)
Unit of Measure: Points
23.1  (18.4) 32.4  (21.1)
7.Secondary Outcome
Title To Compare the Change in KOOS Symptoms Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
106 enrolled knees, 11 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome (0 Inv & 1 Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 45 50
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
45 50
Mean (Standard Deviation)
Unit of Measure: Points
29.8  (21.7) 30.5  (22.1)
8.Secondary Outcome
Title To Compare the Change in KOOS Symptoms Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
106 enrolled knees, 15 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 1 Contr)+ 3 Lost to follow up (2 Inv & 1 Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 43 48
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
43 48
Mean (Standard Deviation)
Unit of Measure: Points
30.5  (20.9) 33.5  (25.0)
9.Secondary Outcome
Title To Compare the Change in KOOS Symptoms Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early due to a slow recruitment rate. 5 year data not available.
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 3-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 44 51
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
44 51
Mean (Standard Deviation)
Unit of Measure: Points
36.0  (18.7) 43.7  (20.1)
11.Secondary Outcome
Title To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
106 enrolled knees, 11 of which excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome (0 Inv & 1 Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 45 50
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
45 50
Mean (Standard Deviation)
Unit of Measure: Points
41.5  (18.5) 44.0  (23.0)
12.Secondary Outcome
Title To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
106 enrolled knees, 15 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 43 48
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
43 48
Mean (Standard Deviation)
Unit of Measure: Points
39.6  (18.7) 42.5  (23.5)
13.Secondary Outcome
Title To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early due to a slow recruitment rate.
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 3-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 11 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 2 Missing outcome (1Inv & 1Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 44 51
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
44 51
Mean (Standard Deviation)
Unit of Measure: Points
14.4  (22.3) 17.4  (24.7)
15.Secondary Outcome
Title To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
106 enrolled knees, 13 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 3 Missing outcome (0 Inv & 3 Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 45 48
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
45 48
Mean (Standard Deviation)
Unit of Measure: Points
35.4  (27.7) 33.5  (25.1)
16.Secondary Outcome
Title To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
106 enrolled knees, 16 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr) + 1 Missing outcome (1 Inv & 0 Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 42 48
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
42 48
Mean (Standard Deviation)
Unit of Measure: Points
36.6  (27.8) 37.8  (25.3)
17.Secondary Outcome
Title To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early due to slow recruitment rate, 5 year data not available.
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 3-6 months
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 11 of which excluded from analysis due to:{0 deaths + 8 Protocol Violations + 1 Lost to follow up (1Inv & 0Contr) + 2 Missing outcome (1Inv & 1Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 44 51
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
44 51
Mean (Standard Deviation)
Unit of Measure: Points
42.2  (26.7) 48.0  (26.2)
19.Secondary Outcome
Title To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
106 enrolled knees, 13 of which excluded from the analysis due to:{0 Deaths+ 8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 3 Missing outcome (0 Inv & 3 Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 45 48
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
45 48
Mean (Standard Deviation)
Unit of Measure: Points
49.0  (29.0) 51.7  (27.7)
20.Secondary Outcome
Title To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 16 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv & 4 Contr) + 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr) + 1 Missing outcome (1 Inv & 0 Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 42 48
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
42 48
Mean (Standard Deviation)
Unit of Measure: Points
44.3  (31.6) 50.8  (23.6)
21.Secondary Outcome
Title To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early due to slow recruitment rate. 5 Year data not available.
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.
Time Frame 3 - 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (1Inv & 0Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 44 52
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
44 52
Mean (Standard Deviation)
Unit of Measure: Points
36.3  (17.9) 39.1  (15.7)
23.Secondary Outcome
Title To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
106 enrolled knees, 11 knees excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv, 4 Contr) + 2 lost to follow up (1 Inv, 1 Contr) + 1 missing outcome (1 Inv, 0 Contr) }
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 44 51
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
44 51
Mean (Standard Deviation)
Unit of Measure: Points
40.0  (17.6) 38.9  (17.2)
24.Secondary Outcome
Title To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
106 enrolled knees, 18 knees excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv, 4 Contr) + 4 revisions (1 Inv, 1 Contr) + 3 Lost to follow up (2 Inv, 1 Contr) + 3 missing outcome (0 Inv, 3 Cntr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 43 45
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
43 45
Mean (Standard Deviation)
Unit of Measure: Points
37.3  (20.6) 36.8  (19.6)
25.Secondary Outcome
Title To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early due to a slow recruitment rate. 5 year data not available.
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
0 0
No data displayed because Outcome Measure has zero total analyzed.
26.Secondary Outcome
Title To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.
Time Frame 3 - 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (1Inv & 0Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 44 52
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
44 52
Mean (Standard Deviation)
Unit of Measure: Points
25.0  (19.6) 28.9  (17.3)
27.Secondary Outcome
Title To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (1Inv & 0Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 44 51
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
44 51
Mean (Standard Deviation)
Unit of Measure: Points
30.5  (19.3) 30.1  (19.9)
28.Secondary Outcome
Title To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 16 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 43 47
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
43 47
Mean (Standard Deviation)
Unit of Measure: Points
24.9  (18.4) 26.5  (18.1)
29.Secondary Outcome
Title To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early due to a slow recruitment rate. 5 Year data not available.
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
0 0
No data displayed because Outcome Measure has zero total analyzed.
30.Secondary Outcome
Title To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.
Time Frame 3 - 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (0Inv & 1Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 45 51
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
45 51
Mean (Standard Deviation)
Unit of Measure: Points
-14.4  (8.8) -18.0  (8.7)
31.Secondary Outcome
Title To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 12 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 2 Missing outcome (1Inv & 1Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 44 50
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
44 50
Mean (Standard Deviation)
Unit of Measure: Points
-18.7  (8.6) -19.4  (8.7)
32.Secondary Outcome
Title To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 17 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr) + 2 Missing outcome (0Inv & 2Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 43 46
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
43 46
Mean (Standard Deviation)
Unit of Measure: Points
-17.3  (9.7) -19.1  (9.6)
33.Secondary Outcome
Title To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early due to a slow recruitment rate. 5 Year data not available.
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
0 0
No data displayed because Outcome Measure has zero total analyzed.
34.Secondary Outcome
Title To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 3 - 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 9 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 45 52
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
45 52
Mean (Standard Deviation)
Unit of Measure: Points
-0.58  (0.62) -0.58  (0.57)
35.Secondary Outcome
Title To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 45 50
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
45 50
Mean (Standard Deviation)
Unit of Measure: Points
-0.62  (0.58) -0.50  (0.58)
36.Secondary Outcome
Title To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 15 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 43 48
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
43 48
Mean (Standard Deviation)
Unit of Measure: Points
-0.58  (0.63) -0.48  (0.58)
37.Secondary Outcome
Title To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early to slow recruitment rate. 5 Year data not available.
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
0 0
No data displayed because Outcome Measure has zero total analyzed.
38.Secondary Outcome
Title To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 3 - 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 9 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 45 52
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
45 52
Mean (Standard Deviation)
Unit of Measure: Points
-0.04  (0.56) -0.19  (0.56)
39.Secondary Outcome
Title To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
106 enrolled knees, 11 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome ( 0 Inv & 1 Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 45 50
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
45 50
Mean (Standard Deviation)
Unit of Measure: Points
-0.11  (0.49) -0.22  (0.58)
40.Secondary Outcome
Title To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
106 enrolled knees, 15 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 43 48
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
43 48
Mean (Standard Deviation)
Unit of Measure: Points
-0.07  (0.51) -0.15  (0.55)
41.Secondary Outcome
Title To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early due to slow recruitment rate. 5 Year data not available.
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
0 0
No data displayed because Outcome Measure has zero total analyzed.
42.Secondary Outcome
Title To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 3 - 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 45 52
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
45 52
Mean (Standard Deviation)
Unit of Measure: Points
-0.40  (0.65) -0.50  (0.58)
43.Secondary Outcome
Title To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 45 50
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
45 50
Mean (Standard Deviation)
Unit of Measure: Points
-0.53  (0.63) -0.48  (0.61)
44.Secondary Outcome
Title To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 43 48
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
43 48
Mean (Standard Deviation)
Unit of Measure: Points
-0.42  (0.59) -0.44  (0.58)
45.Secondary Outcome
Title To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early due to slow recruitment rate. 5 Year data not available.
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
0 0
No data displayed because Outcome Measure has zero total analyzed.
46.Secondary Outcome
Title To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 3 - 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 45 52
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
45 52
Mean (Standard Deviation)
Unit of Measure: Points
-0.56  (0.81) -0.67  (0.83)
47.Secondary Outcome
Title To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 45 50
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
45 50
Mean (Standard Deviation)
Unit of Measure: Points
-0.67  (0.77) -0.68  (0.82)
48.Secondary Outcome
Title To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 43 48
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
43 48
Mean (Standard Deviation)
Unit of Measure: Points
-0.72  (0.83) -0.60  (0.82)
49.Secondary Outcome
Title To Compare the Change in EQ-5D3L Pain/Discomfort Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early due to slow recruitment rate. 5 Year data not available.
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
0 0
No data displayed because Outcome Measure has zero total analyzed.
50.Secondary Outcome
Title To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 3 - 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 45 52
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
45 52
Mean (Standard Deviation)
Unit of Measure: Points
-0.27  (0.72) -0.27  (0.63)
51.Secondary Outcome
Title To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 45 50
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
45 50
Mean (Standard Deviation)
Unit of Measure: Points
-0.24  (0.65) -0.24  (0.62)
52.Secondary Outcome
Title To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 43 48
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
43 48
Mean (Standard Deviation)
Unit of Measure: Points
-0.21  (0.80) -0.17  (0.63)
53.Secondary Outcome
Title To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 3 - 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 45 52
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
45 52
Mean (Standard Deviation)
Unit of Measure: Points
18.3  (23.7) 16.4  (23.3)
54.Secondary Outcome
Title To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 13 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 3 Missing outcome (0Inv & 3Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 45 48
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
45 48
Mean (Standard Deviation)
Unit of Measure: Points
20.6  (26.5) 13.6  (26.5)
55.Secondary Outcome
Title To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (4Inv & 4Contr)+ 3 Lost to follow up (2Inv & 1Contr)}
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 43 48
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
43 48
Mean (Standard Deviation)
Unit of Measure: Points
10.8  (24.7) 11.4  (26.2)
56.Secondary Outcome
Title To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Hide Description EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early due to slow recruitment rate. 5 Year data not available.
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description:
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Overall Number of Participants Analyzed 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Knees
0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early.
Adverse Event Reporting Description Study protocol was designed and executed on using ‘knees’ as study units. Adverse events were collected based on the knees being investigated, not per participant, it is not possible to regroup data 'per participant'. Therefore the numbers affected and at risk below are referring to knees.
 
Arm/Group Title PFC Sigma RP-F PFC Sigma RP
Hide Arm/Group Description PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
All-Cause Mortality
PFC Sigma RP-F PFC Sigma RP
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
PFC Sigma RP-F PFC Sigma RP
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/50 (14.00%)      7/56 (12.50%)    
Cardiac disorders     
Cardiac disorder  0/50 (0.00%)  0 1/56 (1.79%)  1
General disorders     
Pain  4/50 (8.00%)  4 2/56 (3.57%)  2
Immune system disorders     
Allergy to metals  1/50 (2.00%)  1 0/56 (0.00%)  0
Infections and infestations     
Infection  1/50 (2.00%)  1 0/56 (0.00%)  0
Injury, poisoning and procedural complications     
Femur fracture  0/50 (0.00%)  0 1/56 (1.79%)  1
Joint dislocations  0/50 (0.00%)  0 2/56 (3.57%)  2
Musculoskeletal and connective tissue disorders     
Joint crepitation  3/50 (6.00%)  3 2/56 (3.57%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm Malignant  3/50 (6.00%)  3 1/56 (1.79%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PFC Sigma RP-F PFC Sigma RP
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/56 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
DePuy reserves the right to review the contents of publications in advance.The PI may freely disclose the trial results only after DePuy has been given the opportunity of reviewing the proposed results communications at least 30 days prior to the intended release.DePuy will advise the PI of any perceived errors,omissions or corrections but the PI will retain final editorial control.In case of disagreement,DePuy and the PI will make every effort to meet in order to discuss and resolve any issues.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kimberly Dwyer, PhD, CCRA
Organization: DePuy Ortho Joint US
EMail: kdwyer2@its.jnj.com
Layout table for additonal information
Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00733369    
Other Study ID Numbers: CT 06/03
First Submitted: August 12, 2008
First Posted: August 13, 2008
Results First Submitted: March 22, 2014
Results First Posted: August 26, 2014
Last Update Posted: September 13, 2016