N/A
Completed N=142
Comparison of High Flex and Standard Rotating Platform Total Knee Arthroplasty (TKA)
Source: ClinicalTrials.gov NCT01176292 ↗Enrolled (actual)
142
Serious AEs
7.8%
Results posted
Aug 2015
Primary outcomePrimary: Clinical Flexion — 119.1; 120.3; 112.0; 111.3 degrees
Summary
The goal of this study is to determine if the rotating platform high flex design provides improved flexion compared to the standard rotating platform TKA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Flexion |
124.2; 124.0 | — |
| SECONDARY Radiographic Flexion |
117.6; 117.9 | — |
| SECONDARY Knee Society Score (KSS) |
95.0; 94.9; 87.7; 90.9 | — |
| SECONDARY Oxford Knee Score |
41.0; 41.8 | — |
Eligibility Criteria
Inclusion Criteria
- Age 40 to 75 years old
- Primary diagnosis of osteoarthritis of the knee
- Patients who, in the investigator's opinion, are appropriate candidates for a cemented, rotating platform TKA.
- Patients who, in the investigator's opinion, are capable of participation in a clinical trial and reliable enough to return for follow-up appointments.
Exclusion Criteria
- Pregnant or lactating female subjects
- Patients with post-traumatic or inflammatory arthritis
- Patients with a fixed flexion contracture of greater than 20 degrees
- Patients with advanced hip, spine, or ankle disease
- Patients with a BMI greater than 40, where knee flexion may be limited by soft tissues
Data sourced from ClinicalTrials.gov (NCT01176292). 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.