Long-Term Multicenter Evaluation of the E1® Tibial Bearing

Status unconfirmed · Not applicable

Conditions studied: Osteoarthritis of the Knee, Traumatic Arthritis of the Knee

In brief

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.

Key facts

Study ID

NCT01374230

Run by

Massachusetts General Hospital

People needed

500

Starts

2011-09-01

Expected to finish

2021-09-01

Last updated by the study team

2018-07-30

Who can join

Age: 20 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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