Clinical trial NCT00698750: A Clinical Investigation of the Copeland™ Humeral Resurfacing Head
Official title: A Prospective, Non-controlled, Clinical Investigation of the Copeland™ Humeral Resurfacing Head
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis
Rheumatoid Arthritis
Avascular Necrosis
Humeral Fractures
Keywords: Fractured Humeral Head
Traumatic Arthritis
Resurfacing Shoulder
Shoulder Replacement
Shoulder Arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring humeral resurfacing.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: ASES Assessment
timeFrame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
measure: X-rays
timeFrame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary outcomes:
measure: Incidence of revision or removals
timeFrame: Any time
Other outcomes:
Locations:
Study officials:
affiliation: Director, Clinical Research, Biomet Orthopedics, LLC
name: Kenneth J Beres, MD
role: STUDY_DIRECTOR
References: