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Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

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ClinicalTrials.gov Identifier: NCT00289094
Recruitment Status : Completed
First Posted : February 9, 2006
Results First Posted : December 10, 2010
Last Update Posted : August 14, 2013
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Osteoarthritis
Rheumatoid Arthritis
Post-traumatic Arthritis
Juvenile Rheumatoid Arthritis
Avascular Necrosis of Bone
Interventions Device: Total Knee Replacement
Device: Total knee replacement
Enrollment 99
Recruitment Details Two US clinical centers performed 99 primary knee replacements in 86 subjects. Recruitment was based on the inclusion and exclusion criteria as specified in the clinical investigation plan.
Pre-assignment Details Immediately before surgery, the implant type was determined according to the randomization schedule. Before treatment assignment, consented subjects could be excluded from the trial based on results of pre-operative clinical evaluations and/or radiographs, as per the exclusion criteria in the CIP.
Arm/Group Title Rotating Platform Fixed Bearing
Hide Arm/Group Description P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion. P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
Period Title: Overall Study
Started 50 49
Completed 3 2
Not Completed 47 47
Arm/Group Title Rotating Platform Fixed Bearing Total
Hide Arm/Group Description P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion. P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base. Total of all reporting groups
Overall Number of Baseline Participants 50 49 99
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 49 participants 99 participants
63.7  (6.2) 66.9  (5.1) 65.3  (5.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 99 participants
Female
31
  62.0%
26
  53.1%
57
  57.6%
Male
19
  38.0%
23
  46.9%
42
  42.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 49 participants 99 participants
50 49 99
1.Primary Outcome
Title Knee Society Scores
Hide Description 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.
Time Frame Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rotating Platform Fixed Bearing
Hide Arm/Group Description:
P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
Overall Number of Participants Analyzed 50 49
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Pre-operative 40.8  (19.8) 43.4  (23.0)
6 months 84.3  (14.7) 77.8  (14.9)
12 months 86.4  (13.0) 86.4  (10.0)
24 months 89.7  (9.2) 88.1  (8.8)
36 months 92.3  (8.2) 87.1  (10.4)
48 months 94.3  (5.6) 86.0  (14.7)
60 months 95.0  (4.6) 95.5  (3.5)
2.Secondary Outcome
Title Complications/Revisions
Hide Description [Not Specified]
Time Frame On-going to end of study.
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Medical Imaging
Hide Description [Not Specified]
Time Frame Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Outcome Measure Data Not Reported
4.Secondary Outcome
Title SF-12 Patient Outcomes
Hide Description [Not Specified]
Time Frame Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rotating Platform Fixed Bearing
Hide Arm/Group Description P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion. P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
All-Cause Mortality
Rotating Platform Fixed Bearing
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Rotating Platform Fixed Bearing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/50 (6.00%)      1/49 (2.04%)    
Cardiac disorders     
Cardiacvascular arrhythmia  2/50 (4.00%)  2 0/49 (0.00%)  0
General disorders     
Death  1/50 (2.00%)  1 0/49 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Femoral Fracture  0/50 (0.00%)  0 1/49 (2.04%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rotating Platform Fixed Bearing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/49 (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.
Results Point of Contact
Name/Title: Tammy O'Dell, EMT, CCRA
Organization: DePuy Orthopaedics, Inc.
Phone: 574-372-7104
Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00289094     History of Changes
Other Study ID Numbers: SRP-2
First Submitted: February 7, 2006
First Posted: February 9, 2006
Results First Submitted: September 29, 2010
Results First Posted: December 10, 2010
Last Update Posted: August 14, 2013