Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00289094
First received: February 7, 2006
Last updated: August 6, 2013
Last verified: August 2013

February 7, 2006
August 6, 2013
March 2001
September 2009   (final data collection date for primary outcome measure)
Knee Society Scores [ Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. ] [ Designated as safety issue: No ]
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.
Knee Society scores
Complete list of historical versions of study NCT00289094 on ClinicalTrials.gov Archive Site
  • Complications/Revisions [ Time Frame: On-going to end of study. ] [ Designated as safety issue: Yes ]
  • Medical Imaging [ Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. ] [ Designated as safety issue: Yes ]
  • SF-12 Patient Outcomes [ Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. ] [ Designated as safety issue: No ]
  • Complications/Revisions,
  • Radiographic findings,
  • SF-12 patient outcomes
Not Provided
Not Provided
 
Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA
Multi-center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases

The purpose of this study is to evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.

This study will evaluate the clinical performance of rotating platform and fixed bearing knee implants. This will be done by obtaining a series of primary total knee replacements. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee System or the P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System and assignment is randomized.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Post-traumatic Arthritis
  • Juvenile Rheumatoid Arthritis
  • Avascular Necrosis of Bone
  • Device: Total Knee Replacement
    Rotating Platform (RP) Cruciate Retaining Knee System
    Other Name: P.F.C.® Sigma™ RP Cruciate Retaining Knee System
  • Device: Total knee replacement
    Fixed Cruciate Retaining Knee System
    Other Name: P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System
  • Active Comparator: 1
    P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System
    Intervention: Device: Total Knee Replacement
  • Active Comparator: 2
    P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System
    Intervention: Device: Total knee replacement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Osteoarthritis
  • Rheumatoid Arthritis
  • Other inflammatory arthritis
  • Avascular necrosis of bone

Exclusion Criteria:

  • Prior ipsilateral TKA
  • Metabolic disorders
  • Joint replacement due to autoimmune disorders
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00289094
SRP-2
No
DePuy Orthopaedics
DePuy Orthopaedics
Not Provided
Study Director: Tammy L O'Dell, EMT, CCRA, CCRC DePuy Orthopaedics
DePuy Orthopaedics
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP