N/A
Completed N=1,250
Evaluation of Patellar Crepitus Following Total Knee Arthroplasty
Total Knee Replacement
Source: ClinicalTrials.gov NCT01340144 ↗
Enrolled (actual)
1,250
Serious AEs
5.9%
Results posted
Mar 2015
Primary outcomePrimary: Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject. — 78; 82; 31; 24 participants
Summary
Analyze clinical data for a group of subjects implanted with a new surgical device designed to reduce the incidence of patellar crepitus following PCL-substituting TKA and compare that to a control group of subjects implanted with a TKA design known to have an incidence of patellar crepitus of approximately 5%.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject. |
78; 82; 31; 24; 18; 7 | — |
Eligibility Criteria
Inclusion Criteria
- subjects that received primary total knee replacement
Exclusion Criteria
- Did not return for follow - up appointments Required any post operative manipulation
Data sourced from ClinicalTrials.gov (NCT01340144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.