Phase 3
Completed N=419
Mobile - Bearing Knee Study
Inflammatory Tissue Disorder · Osteoarthritis · Avascular Necrosis · Post-traumatic Arthritis
Source: ClinicalTrials.gov NCT00765362 ↗
Enrolled (actual)
419
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcomePrimary: Knee Society Score Evaluation — 93.1 Average Knee Rating Score
Summary
To evaluate the safety and efficacy of the Encore Mobile-Bearing Knee.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knee Society Score Evaluation |
93.1 | — |
| PRIMARY Knee Society Function Score |
89.0 | — |
| PRIMARY Knee Society Scores Used as Success/Failure Criteria. |
91; 84 | — |
Eligibility Criteria
Inclusion Criteria
- Skeletal maturity
- Less than 70 on preoperative Knee Society Score (Rating Score)
- Sufficient bone stock, as judged by radiographs, to support primary knee implant
- Patients with inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles
- Patient is not pregnant
- Primary total knee replacement
- Sufficient collateral ligaments to support device, as judged by physician during stability testing (varus/valgus and flexion/extension)
- Varus deformity 45 or valgus deformity >45 or fixed flexion deformity >90.
- Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere the with patient's cognitive abilities, senile dementia, and Alzheimer's Disease).
- Prisoners
- Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity).
Data sourced from ClinicalTrials.gov (NCT00765362). 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.