Expired Study
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Nashville, Tennessee 37232


Purpose:

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.


Study summary:

Patient follow-up outcomes measured by the ASES score, radiographs and adverse events/revisions.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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.


NCT ID:

NCT00698867


Primary Contact:

Study Director
Russell Schenck, PhD
Director, Clinical Research, Biomet Orthopedics, LLC


Backup Contact:

N/A


Location Contact:

Nashville, Tennessee 37232
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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