Avascular Necrosis, Humeral Fractures, Osteoarthritis, Rheumatoid Arthritis
Conditions
Keywords
Fractured Humeral Head, Traumatic Arthritis, Resurfacing Shoulder, Shoulder Replacement, Shoulder Arthritis
Brief summary
The purpose of this study is to perform a five-year, prospective evaluation of the Copeland™ Humeral Resurfacing Head Prosthesis 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.
Interventions
None listed
Sponsors
Biomet Orthopedics, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. * Rheumatoid arthritis * Correction of functional deformity * Reconstructable Rotator Cuff * Treatment of acute fracture of the humeral head * Traumatic arthritis
Exclusion criteria
* Patients less than 18 years. * Patients with rapid joint destruction, osteomalacia, osteoporosis, or marked bone loss, which would preclude proper fixation of the prosthesis. * Patients with marked bone loss apparent on roentgenogram. * Metabolic disorders, which may impair bone formation. * Patients who are pregnant. * Patients with an active or suspected infection in or around the shoulder or distant foci of infections, which may spread to the implant site. * Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue, which would prelude stability of the prosthesis. * Patients who have had revision procedures where other devices or treatments have failed. * 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 a cemented or cementless partial or total shoulder replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol. * Patients with previous shoulder surgery or conditions that may interfere with the partial or total shoulder replacement's survival or outcome. * Patients who qualify for inclusion in the study, but refuse consent to participate in the study. * Patients who have had a partial or total shoulder arthroplasty on the contralateral shoulder within the last year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASES Assessment | 6 months, 1 year, 2 years, 3 years, 4 years, 5 years |
| X-rays | 6 months, 1 year, 2 years, 3 years, 4 years, 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of revision or removals | Any time |
Outcome results
None listed