A Clinical Investigation of the Discovery™ Elbow System

Completed

Conditions studied: Osteoarthritis, Rheumatoid Arthritis, Avascular Necrosis, Humeral Fractures

In brief

The purpose of this study is to perform a five-year, multi-center prospective evaluation of the Discovery™ Elbow System for outcome and durability. Relief of pain and restoration of function will determine long-term clinical outcome while durability will be measured by the absence of revisions.

Key facts

Study ID

NCT00698867

Run by

Biomet Orthopedics, LLC

People needed

118

Starts

2002-06-01

Expected to finish

2016-07-01

Last updated by the study team

2017-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Inflammatory arthritis
• Revision where other devices or treatments have failed
• Correction of functional deformity
• Treatment of acute fractures or non-union about the elbow
• Patient Selection factors to be considered include:
• Need to obtain pain relief and improve function.
• Ability and willingness to follow instructions including control of weight and activity levels.
• Patients who are able and willing to return for follow-up evaluations.
• Patients with a good nutritional state.
• Patients with full skeletal maturity.
• Patients of all races and gender.
• Patients who are able to follow care instructions.

You may not qualify if…

• Patients less than 18 years.
• Patients with marked bone loss which would preclude proper fixation of the prosthesis.
• Metabolic disorders, which may impair bone formation.
• Patients who are pregnant.
• Patients with an active or suspected infection in or around the elbow or distant foci of infections, which may spread to the implant site.
• Patients with a highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, neoplastic disease, etc.).
• Patients unwilling or unable to comply with a rehabilitation program for elbow replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
• Patients who qualify for inclusion in the study, but refuse consent to participate in the study.

Where it is running

• Florida Orthopedic Institute — Tampa, Florida, United States
• Indiana Hand to Shoulder Center — Indianapolis, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Vanderbilt Hand Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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