Osteoarthritis of the Knee Clinical Trial
Official title:
Long-Term Multicenter Evaluation of the E1® Tibial Bearing
Verified date | July 2018 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 500 |
Est. completion date | September 2021 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Aalborg Universitetshospital, Göteborg University, Hospital Universitario La Paz, Hvidovre University Hospital, Kennedy Center at Ascension Mercy Hospital, Seoul National University Hospital, Southern Joint Replacement Institute, Stanford University, Sydney Private Hospital, Australia, Ulsan University Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survivorship, as determined by the implant remaining within the patient. | 10 years |
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