Long-Term Multicenter Evaluation of the E1® Tibial Bearing
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 20 - 75 |
| Updated: | 8/1/2018 |
| Start Date: | September 2011 |
| End Date: | September 2021 |
This study has been designed to document the long-term outcome of the E1® Tibial Bearings
used with the Vanguard® Knee System in 500 patients receiving total knee arthroplasty. All
patients will receive the E1® Tibial Bearing in a Vanguard® knee replacement. Radiographic
analysis and patient reported outcomes will be used as follow-up measures to track wear,
mechanical performance, and patient satisfaction.
used with the Vanguard® Knee System in 500 patients receiving total knee arthroplasty. All
patients will receive the E1® Tibial Bearing in a Vanguard® knee replacement. Radiographic
analysis and patient reported outcomes will be used as follow-up measures to track wear,
mechanical performance, and patient satisfaction.
Inclusion Criteria:
- Male or Female
- 20 to 75 years of age
- Subjects requiring total knee replacement
- Subjects with the diagnosis of osteoarthritis, or traumatic arthritis
- Subjects who demonstrate the ability to return to Massachusetts General Hospital for
follow-up for the next 10 years
Exclusion Criteria:
- Subjects with osteoporosis, osteomalacia, or neuromuscular disease
- Incomplete or insufficient soft tissue around the knee
- Subjects with a limited life span
- Subjects who have difficulty comprehending the study protocol for any reason
- Subjects with disorders which may impair bone formation
- Subjects whose bony structure deviates substantially from the general norm
- Female subjects that are, or may become, pregnant while participating in this study
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