Approval Probability
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Encore Mobile-Bearing Knee · 1 trial · 5 indications
The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (\<70).
The patient function score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of \> or = to 60 on the function score is considered success. Minimum score = 0, maximum score = 100 with the higher the score representing a better outcome.
The maximum score for each of the sections is 100 points. A score of at least 80 points on the 2-year knee assessment score was defined as a success.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Subjects who are candidates for a total knee replacement and meet the inclusion/exclusion criteria of the study. |
| Name | Type | Description |
|---|---|---|
| Encore Mobile-Bearing Knee | DEVICE | Used for primary total knee replacement |
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, o...
Encore Mobile-Bearing Knee is a medical device used for treating inflammatory tissue disorder, as well as osteoarthritis, avascular necrosis, post-traumatic arthritis, and secondary arthritis. It is designed for patients aged 18 years and older. The device is currently in Phase 3 clinical development.
Encore Mobile-Bearing Knee is developed by Enovis Corporation, a company publicly traded under the ticker symbol ENOV. The device is being studied for use in musculoskeletal conditions, specifically for patients with inflammatory tissue disorder and related joint conditions.
Encore Mobile-Bearing Knee is in Phase 3 clinical development. It is an investigational device and has not been approved by regulatory authorities. One Phase 3 clinical trial has been completed to evaluate its safety and effectiveness.
Encore Mobile-Bearing Knee has been studied in one clinical trial with the identifier NCT00765362, titled 'Mobile - Bearing Knee Study'. This Phase 3 trial was completed and enrolled 419 participants in the United States. The trial was not randomized or double-blinded and had no control group.
Encore Mobile-Bearing Knee is a specific mobile-bearing knee device developed by Enovis Corporation. It is designed to address conditions such as inflammatory tissue disorder and osteoarthritis. The device is currently in Phase 3 clinical trials and is not yet approved for general use.