An interventional study of Total Knee Replacement and Total knee replacement in Osteoarthritis, Arthritis, Rheumatoid and Avascular Necrosis of Bone, sponsored by DePuy Orthopaedics. Terminated at 4 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-05-13.
Sponsored by DePuy Orthopaedics · Not applicable, Interventional, and Treatment
The purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.
The study will evaluate the clinical performance of cruciate ligament retaining or cruciate ligament substituting implants through a series of primary TKAs. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee implant or the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee implant and assignment will be randomized.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 399 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →DePuy Orthopaedics is the lead sponsor of 42 studies on the registry; 2 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Rotating Platform Cruciate Retaining Knee implant
Device: Total Knee Replacement
Rotating Platform Cruciate Substituting Knee implant.
Device: Total knee replacement
Rotating Platform (RP) Cruciate Retaining Knee implant
Also known as: P.F.C.® Sigma™ RP Cruciate Retaining Knee implant
Rotating Platform (RP) Cruciate Substituting Knee implant.
Also known as: P.F.C.® Sigma™ RP Cruciate Substituting Knee implant.
Knee Society scores
Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Complications
Time frame: On-going to end of study
Revisions
Time frame: On-going to end of study
Medical imaging
Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
SF-12 patient outcomes
Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
This study is terminated, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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DePuy Orthopaedics