A Clinical Investigation of the Discovery™ Elbow System

Condition(s) targeted: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; Humeral Fractures

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Biomet Orthopedics, Inc.

Official(s) and/or principal investigator(s):
Kenneth J Beres, MD, Study Director, Affiliation: Director, Clinical Research, Biomet Orthopedics, Inc

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.

Official title: A Prospective, Non-Controlled, Clinical Investigation of the Discovery™ Elbow System

Study design: Cohort, Prospective

Primary outcome:

ASES Assessment

X-rays

Secondary outcome: Incidence of revision or removals

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Starting date: June 2002
Ending date: June 2015
Last updated: June 13, 2008