A Clinical Investigation of the Copeland™ Humeral Resurfacing Head

NCT00698750 | Terminated

• 1 other identifier: Biomet 12381-30
• Study Type: observational
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; Humeral Fractures

Keywords

Fractured Humeral Head; Traumatic Arthritis; Resurfacing Shoulder; Shoulder Replacement; Shoulder Arthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence of revision or removals

  Any time

Study Arms (1)

Copeland™ Humeral Resurfacing Head

Copeland™ Humeral Resurfacing Head

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring humeral resurfacing.

You may qualify if:

• 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

You may not qualify if:

• 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 have had a partial or total shoulder arthroplasty on the contralateral shoulder within the last year.

Sponsors & Collaborators

• Biomet Orthopedics, LLC: lead

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Osteonecrosis; Humeral Fractures

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Kenneth J Beres, MD

  Director, Clinical Research, Biomet Orthopedics, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 17, 2008
• Study Start: April 1, 2004
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: June 21, 2017

Record last verified: 2017-06