Long-Term Multicenter Evaluation of the E1® Tibial Bearing

Massachusetts General Hospital500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Osteoarthritis of the Knee Traumatic Arthritis of the Knee

Interventions

Total knee arthroplastyPROCEDURE

Primary total knee arthroplasty surgery for the treatment of osteoarthritis.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Survivorship, as determined by the implant remaining within the patient.

Time frame: 10 years

Data from ClinicalTrials.gov

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