Official Title: “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.

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: June 2015

Arms, Groups and Cohorts in this Clinical Trial

• : Discovery™ Elbow
  • Discovery™ Elbow

Primary Measures

• ASES Assessment
  • Time Frame: 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
    Safety Issue?: No
• X-rays
  • Time Frame: 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
    Safety Issue?: No

Secondary Measures

• Incidence of revision or removals
  • Time Frame: Any time
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Biomet Orthopedics, LLC

Overall Clinical Trial Officials and Contacts

Kenneth J Beres, MD Study Director Director, Clinical Research, Biomet Orthopedics, LLC  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00698867

Study ID Number: Biomet 12381-8

ClinicalTrials.gov Identifier: NCT00698867

Health Authority: United States: Institutional Review Board