CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 149 enrolled
Drug / intervention
Total Knee Arthroplasty +1 moredevice
Likely dose
Total Knee Arthroplasty with P.F.C. Sigma Rotating Platform or Fixed Cruciate Substituting Knee System (surgical procedure)AI-extracted
Key inclusion· 6
  • ✓Osteoarthritis
  • ✓Rheumatoid arthritis
  • ✓Other inflammatory arthritis
  • ✓Avascular necrosis of bone
Key exclusion· 9
  • ✕History of recent or active joint sepsis
  • ✕Charcot neuropathy
  • ✕Psycho-social disorders that would limit rehabilitation
  • ✕Age greater than 75 years at time of surgery

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00289107
NCT00289107N/ACompleted
CompareCT.gov

Multi-center, Prospective, Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting vs P.F.C.® Sigma™ Cruciate Substituting Knee Primary Cases

DePuy Orthopaedics·interventional·Posted Feb 9, 2006·Updated May 3, 2023

In Brief

A clinical study evaluating Total Knee Arthroplasty and Total knee replacement for Osteoarthritis and 5 related conditions. Completed, enrolled 149 participants across 3 sites.

Detailed Summary

The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Rheumatoid Arthritis, Other Inflammatory Arthritis, Post-Traumatic Arthritis, Juvenile Rheumatoid Arthritis, Avascular Necrosis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 9, 2006
Enrollment StartApr 1, 2001
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 20.4 years ago

Interventions

Total Knee Arthroplastydevice

Rotating Platform (RP) Cruciate Substituting Knee System

Total knee replacementdevice

Fixed Cruciate Substituting Knee System