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Gamma Vacuum Foil (GVF) Versus Cross-linked Polyethylene in Total Knee Arthroplasty Study

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: NCT00289133
Recruitment Status : Completed
First Posted : February 9, 2006
Results First Posted : July 15, 2016
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Osteoarthritis, Knee
Arthritis, Rheumatoid
Intervention Device: total knee arthroplasty
Enrollment 938
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GVF Poly XLK Poly
Hide Arm/Group Description Gamma Vacuum Foil polyethylene tibial component Cross-linked polyethylene tibial component
Period Title: Overall Study
Started 461 477
Completed 189 179
Not Completed 272 298
Reason Not Completed
Non-study device implanted             12             0
Protocol Violation             32             38
Withdrawal by Subject             9             10
Death             5             10
Lost to Follow-up - Hurricane Katri             73             74
Physician Decision             41             45
Revision             8             6
Lost to Follow-up             92             115
Arm/Group Title GVF Poly XLK Poly Total
Hide Arm/Group Description Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert Total of all reporting groups
Overall Number of Baseline Participants 449 477 926
Hide Baseline Analysis Population Description
Enrolled Subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 449 participants 477 participants 926 participants
66.3  (8.5) 66.4  (8.5) 66.3  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 449 participants 477 participants 926 participants
Female
290
  64.6%
308
  64.6%
598
  64.6%
Male
159
  35.4%
169
  35.4%
328
  35.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 449 participants 477 participants 926 participants
449 477 926
1.Primary Outcome
Title Survivorship (Revision of Any Component for Any Reason)
Hide Description Survival was estimated by Kaplan-Meier method. Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Survivorship can only be calculated on knees (not participants as some study subjects had bilateral knees in the study) with post-operative follow-up. 35 knees were excluded due to post-operative follow-up not being available. 67 knees were excluded due to protocol violations.
Arm/Group Title GVF Poly XLK Poly
Hide Arm/Group Description:
Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert
Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert
Overall Number of Participants Analyzed 337 355
Overall Number of Units Analyzed
Type of Units Analyzed: Number of knees
402 422
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of knees
96.8
(93.9 to 98.4)
98.1
(95.6 to 99.2)
2.Secondary Outcome
Title American Knee Society Evaluation - Total Score
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 year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of knees analyzed was the number available for analysis at this post-operative timepoint.
Arm/Group Title GVF Poly XLK Poly
Hide Arm/Group Description:
Gamma Vacuum Foil polyethylene
Cross-linked polyethylene
Overall Number of Participants Analyzed 240 239
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
240 239
Mean (Standard Deviation)
Unit of Measure: scores on a scale
94.7  (7.9) 93.5  (9.5)
3.Secondary Outcome
Title American Knee Society Evaluation - Total Score
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 Minimum 5 years, up to 7.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of knees analyzed was the number available for analysis at this post-operative timepoint.
Arm/Group Title GVF Poly XLK Poly
Hide Arm/Group Description:
Gamma Vacuum Foil polyethylene tibial component
Cross-linked polyethylene tibial component
Overall Number of Participants Analyzed 145 146
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
145 146
Mean (Standard Deviation)
Unit of Measure: scores on a scale
93.5  (9.2) 93.1  (8.5)
4.Secondary Outcome
Title Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score
Hide Description WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The total score ranged from 0 to 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome.
Time Frame 2 year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of knees analyzed was the number available for analysis at this post-operative timepoint.
Arm/Group Title GVF Poly XLK Poly
Hide Arm/Group Description:
Gamma Vacuum Foil polyethylene
Cross-linked polyethylene
Overall Number of Participants Analyzed 225 221
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
225 221
Mean (Standard Deviation)
Unit of Measure: scores (points) on a scale
10.2  (13.4) 11.5  (15.3)
5.Secondary Outcome
Title Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score
Hide Description WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The total score ranged from 0 to 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome.
Time Frame Minimum 5 years, up to 7.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of knees analyzed was the number available for analysis at this post-operative timepoint.
Arm/Group Title GVF Poly XLK Poly
Hide Arm/Group Description:
Gamma Vacuum Foil polyethylene
Cross-linked polyethylene
Overall Number of Participants Analyzed 139 134
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
139 134
Mean (Standard Deviation)
Unit of Measure: scores (points) on a scale
11.0  (14.1) 9.8  (13.2)
6.Secondary Outcome
Title Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm)
Hide Description [Not Specified]
Time Frame Minimum 5 years, up to 7.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of knees analyzed was the number available for analysis at this post-operative timepoint.
Arm/Group Title GVF Poly XLK Poly
Hide Arm/Group Description:
Gamma Vacuum Foil polyethylene
Cross-linked polyethylene
Overall Number of Participants Analyzed 148 144
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
148 144
Measure Type: Number
Unit of Measure: percentage of knees
9.5 7.6
7.Secondary Outcome
Title Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm)
Hide Description [Not Specified]
Time Frame Minimum 5 years, up to 7.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of knees in which the radiographs were analyzed was the number available for analysis at this post-operative timepoint.
Arm/Group Title GVF Poly XLK Poly
Hide Arm/Group Description:
Gamma Vacuum Foil polyethylene
Cross-linked polyethylene
Overall Number of Participants Analyzed 148 144
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
148 144
Measure Type: Number
Unit of Measure: percentage of knees
0 2.1
8.Secondary Outcome
Title Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm)
Hide Description [Not Specified]
Time Frame Minimum 5 years, up to 7.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of knees in which radiographs were analyzed was the number available for analysis at this post-operative timepoint.
Arm/Group Title GVF Poly XLK Poly
Hide Arm/Group Description:
Gamma Vacuum Foil polyethylene
Cross-linked polyethylene
Overall Number of Participants Analyzed 148 144
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
148 144
Measure Type: Number
Unit of Measure: percentage of knees
0 0
9.Secondary Outcome
Title Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm)
Hide Description [Not Specified]
Time Frame Minimum 5 years, up to 7.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of knees in which radiographs were analyzed was the number available for analysis at this post-operative timepoint.
Arm/Group Title GVF Poly XLK Poly
Hide Arm/Group Description:
Gamma Vacuum Foil polyethylene
Cross-linked polyethylene
Overall Number of Participants Analyzed 148 144
Overall Number of Units Analyzed
Type of Units Analyzed: Knees
148 144
Measure Type: Number
Unit of Measure: percentage of knees
2.0 1.4
Time Frame Intraoperatively and postoperatively through 6 years.
Adverse Event Reporting Description Since study inception, information on whether an adverse event (AE) was deemed to be serious was not collected. AE terms that are consistent with the definition of Serious AEs are included in the Serious AE table. Remaining AEs (serious or not) are included in the "Other" AE table. MedDRA was used to classify each AE into SOC, not Preferred Term.
 
Arm/Group Title GVF Poly XLK Poly
Hide Arm/Group Description Gamma Vacuum Foil polyethylene tibial component Cross-linked polyethylene tibial component
All-Cause Mortality
GVF Poly XLK Poly
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
GVF Poly XLK Poly
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/461 (3.47%)      15/477 (3.14%)    
General disorders     
Death  1 [1]  5/461 (1.08%)  5 4/477 (0.84%)  4
Infections and infestations     
Death  1 [2]  2/461 (0.43%)  2 0/477 (0.00%)  0
Injury, poisoning and procedural complications     
Other - Had fall and fractured left shoulder and had a concussion  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Musculoskeletal and connective tissue disorders     
Other - Flexion Instability  1 [3]  1/461 (0.22%)  1 0/477 (0.00%)  0
Other - Left Hip Revision  1 [4]  1/461 (0.22%)  1 0/477 (0.00%)  0
Other - Severe Low Back Pain  1 [5]  1/461 (0.22%)  1 0/477 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Other - Death  1 [1]  0/461 (0.00%)  0 1/477 (0.21%)  1
Other - Ovarian Cancer  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Other - Stage 4 Terminal Cancer  1  1/461 (0.22%)  1 0/477 (0.00%)  0
Other - Stage 4 Cancer  1  1/461 (0.22%)  1 0/477 (0.00%)  0
Other - Glioblastoma  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Nervous system disorders     
Central Nervous System  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Product Issues     
Dislocation  1  1/461 (0.22%)  1 2/477 (0.42%)  2
Loosening  1  3/461 (0.65%)  3 0/477 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Other - Death  1 [6]  0/461 (0.00%)  0 1/477 (0.21%)  1
Social circumstances     
Other - Death  1 [7]  0/461 (0.00%)  0 1/477 (0.21%)  1
Surgical and medical procedures     
Other - Follow-up Left Knee Arthroscope  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Other - Fall Injured Quad Repair  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
[1]
Unknown Cause
[2]
Complications from Septic Shock due to Necrotic Gallbladder and Bowel
[3]
Revision of right total knee
[4]
Underwent Total Hip Replacement after Breaking Hip
[5]
Led to Neurological Deficit
[6]
From Respiratory Complications and Parkinson's Disease
[7]
Reported Suicide
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GVF Poly XLK Poly
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   146/461 (31.67%)      164/477 (34.38%)    
Cardiac disorders     
Cardiovascular  1  7/461 (1.52%)  7 8/477 (1.68%)  9
Other-Syncope Weakness  1  1/461 (0.22%)  1 0/477 (0.00%)  0
Cardiac Arrhythmia  1  0/461 (0.00%)  0 2/477 (0.42%)  2
Endocrine disorders     
Endocrine/Metabolic  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Gastrointestinal disorders     
Gastrointestinal  1  3/461 (0.65%)  3 3/477 (0.63%)  3
General disorders     
Musculoskeletal  1  4/461 (0.87%)  17 4/477 (0.84%)  14
Central Nervous System  1  2/461 (0.43%)  2 2/477 (0.42%)  2
Pain  1  15/461 (3.25%)  19 17/477 (3.56%)  34
Wound Problem  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Hepatobiliary disorders     
Gastrointestinal  1  1/461 (0.22%)  1 0/477 (0.00%)  0
Infections and infestations     
Infection  1  6/461 (1.30%)  7 5/477 (1.05%)  5
Central Nervous System  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Musculoskeletal  1  0/461 (0.00%)  0 2/477 (0.42%)  3
Other-Positive Nasal Culture for MRSA  1  1/461 (0.22%)  1 0/477 (0.00%)  0
Wound Problem  1  3/461 (0.65%)  3 1/477 (0.21%)  1
Hematological  1  1/461 (0.22%)  1 0/477 (0.00%)  0
Injury, poisoning and procedural complications     
Musculoskeletal  1  3/461 (0.65%)  4 5/477 (1.05%)  9
Hematological  1  1/461 (0.22%)  1 0/477 (0.00%)  0
Fracture  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Metabolism and nutrition disorders     
Endocrine/Metabolic  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Musculoskeletal and connective tissue disorders     
Central Nervous System  1  2/461 (0.43%)  2 1/477 (0.21%)  1
Endocrine/Metabolic  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Extensor Mechanism  1  1/461 (0.22%)  1 0/477 (0.00%)  0
Musculoskeletal  1  30/461 (6.51%)  68 37/477 (7.76%)  87
Other- Feeling of Instability  1  1/461 (0.22%)  1 0/477 (0.00%)  0
Other-Follow-up right knee arthroscope  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Other- Grade 1 Strain Medial Collateral Ligament  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Other-Inflamed bursa over Gerdy's Tubercle  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Other-Mild Limp Secondary to Stiffness  1  1/461 (0.22%)  1 0/477 (0.00%)  0
Other- Patella Tendonitis  1  2/461 (0.43%)  2 0/477 (0.00%)  0
Other- Patella Clunk  1  1/461 (0.22%)  1 1/477 (0.21%)  1
Other- Pes Bursitis; ITB syndrome  1  1/461 (0.22%)  1 0/477 (0.00%)  0
Other- Pesanserinus Tendonitis  1  4/461 (0.87%)  4 1/477 (0.21%)  1
Other- Pre Patellar Bursitis with Peri Patellar tenderness  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Other- Routine F/U to Bilateral knee arthroscopic debulking  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Other- F/U Right Knee Arthroscope  1  0/461 (0.00%)  0 1/477 (0.21%)  1
other- Right Ankle Pain  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Other- Subject has continuous right knee pain (non-surgical knee)  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Other- Synovitis  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Stiffness, Arthrofibrosis, Ankylosis, Limited Range of Motion  1  12/461 (2.60%)  17 9/477 (1.89%)  9
Other - Atraumatic onset of right buttock pain  1  1/461 (0.22%)  1 0/477 (0.00%)  0
Hemarthrosis  1  1/461 (0.22%)  1 2/477 (0.42%)  2
Other - 20 degree flexion contracture  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Other - Bilateral knee pain  1 [1]  0/461 (0.00%)  0 1/477 (0.21%)  1
Other - Bilateral hand numbness and pain  1 [2]  1/461 (0.22%)  1 0/477 (0.00%)  0
Other - Fell and injured quad  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Musculoskeletal  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Nervous system disorders     
Central Nervous System  1  5/461 (1.08%)  6 7/477 (1.47%)  8
Musculoskeletal  1  1/461 (0.22%)  1 0/477 (0.00%)  0
Peripheral Nervous System  1  1/461 (0.22%)  1 1/477 (0.21%)  1
Other - Advanced Alzheimer's  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Sciatica  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Product Issues     
Musculoskeletal  1  1/461 (0.22%)  2 1/477 (0.21%)  1
Other - Radiographic subsidence of the femoral component - asymptomatic  1  1/461 (0.22%)  1 0/477 (0.00%)  0
Renal and urinary disorders     
Genitourinary  1  3/461 (0.65%)  3 3/477 (0.63%)  4
Respiratory, thoracic and mediastinal disorders     
Respiratory System  1  1/461 (0.22%)  1 2/477 (0.42%)  2
Pulmonary Embolism  1  2/461 (0.43%)  2 2/477 (0.42%)  2
Skin and subcutaneous tissue disorders     
Other- Dermis Contact Dermatitis  1  0/461 (0.00%)  0 2/477 (0.42%)  2
Other- Itchy Red Rash  1  1/461 (0.22%)  1 0/477 (0.00%)  0
Other- Psoriasis  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Other- Skin Rash on Low Bilateral Legs  1  1/461 (0.22%)  1 0/477 (0.00%)  0
Wound Problem  1  1/461 (0.22%)  1 0/477 (0.00%)  0
Social circumstances     
Other- Change in Insurance  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Other - Systemic: Voluntary Withdrawal  1 [3]  0/461 (0.00%)  0 1/477 (0.21%)  2
Surgical and medical procedures     
Musculoskeletal  1  10/461 (2.17%)  16 10/477 (2.10%)  12
Peri-op AE - Other  1  4/461 (0.87%)  4 8/477 (1.68%)  8
Extensor Mechanism  1  0/461 (0.00%)  0 1/477 (0.21%)  3
Other - Left knee artrhoscopy  1  0/461 (0.00%)  0 1/477 (0.21%)  2
Vascular disorders     
Hematoma  1  2/461 (0.43%)  2 0/477 (0.00%)  0
Pain  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Thrombosis/Thrombophlebitis  1  6/461 (1.30%)  6 0/477 (0.00%)  0
Musculoskeletal  1  0/461 (0.00%)  0 1/477 (0.21%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
[1]
Right knee pain greater than left knee pain; Arthroscope 2 months post-op
[2]
Carpal Tunnel Syndrome
[3]
Reason not specified; Surgical Site not specified
Serious adverse events were not collected in this study per the modern definition. All adverse events collected for this study will be reported in the 'Other Adverse Events' table. MedDRA was used to classify each AE into SOC, but not Preferred Term.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Portfolio Leader
Organization: DePuy Orthopaedics, Inc.
Phone: 574-372-7231
EMail: shimden@its.jnj.com
Layout table for additonal information
Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00289133    
Other Study ID Numbers: 03111
First Submitted: February 7, 2006
First Posted: February 9, 2006
Results First Submitted: May 30, 2014
Results First Posted: July 15, 2016
Last Update Posted: April 24, 2017