A Clinical Investigation of the Discovery™ Elbow System
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis, Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis, Orthopedic |
Therapuetic Areas: | Rheumatology, Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | June 2002 |
End Date: | June 2016 |
A Prospective, Non-controlled, Clinical Investigation of the Discovery™ Elbow System
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.
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.
Patient follow-up outcomes measured by the ASES score, radiographs and adverse
events/revisions.
events/revisions.
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.
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