Status:
COMPLETED
A Clinical Investigation of the Discovery™ Elbow System
Lead Sponsor:
Biomet Orthopedics, LLC
Conditions:
Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
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 dete...
Detailed Description
Patient follow-up outcomes measured by the ASES score, radiographs and adverse events/revisions.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00698867
Start Date
June 1 2002
End Date
July 1 2016
Last Update
August 7 2017
Active Locations (4)
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1
Florida Orthopedic Institute
Tampa, Florida, United States, 33637
2
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States, 46260
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Vanderbilt Hand Center
Nashville, Tennessee, United States, 37232