Expired Study
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Boston, Massachusetts 02114


Purpose:

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.


Criteria:

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


NCT ID:

NCT01374230


Primary Contact:

Principal Investigator
Charles Bragdon, PhD
Massachusetts General Hospital


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02114
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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