At a glance
ClinicalIndex Comparison RecordN/ACompleted· 99 enrolled
Drug / intervention
Total Knee Replacement +1 moredevice
Likely dose
Total Knee Replacement — Rotating Platform (RP) Cruciate Retaining Knee System vs. Fixed Cruciate Retaining Knee SystemAI-extracted
Key inclusion· 4
- ✓Osteoarthritis
- ✓Rheumatoid Arthritis
- ✓Other inflammatory arthritis
- ✓Avascular necrosis of bone
Key exclusion· 3
- ✕Prior surgery on the same knee (ipsilateral TKA)
- ✕Metabolic disorders
- ✕Joint replacement due to autoimmune disorders
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases
In Brief
A clinical study evaluating Total Knee Replacement and Total knee replacement for Osteoarthritis and 4 related conditions. Completed, enrolled 99 participants across 2 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Juvenile Rheumatoid Arthritis, Avascular Necrosis of Bone
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2001
First PostedFeb 2006
Primary CompletionDec 2007
TodayJul 2026
First PostedFeb 9, 2006
Enrollment StartMar 1, 2001
Primary CompletionDec 26, 2007
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 20.4 years ago
Interventions
Total Knee Replacementdevice
Rotating Platform (RP) Cruciate Retaining Knee System
Total knee replacementdevice
Fixed Cruciate Retaining Knee System