A Clinical Investigation of the Discovery™ Elbow System

Zimmer Biomet

Status: Completed

Conditions: Humeral Fractures; Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT00698867

ORTHO.CR.EX001

Details and patient eligibility

About

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.

Full description

Patient follow-up outcomes measured by the ASES score, radiographs and adverse events/revisions.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

118 participants in 1 patient group

Discovery™ Elbow

Description:

Discovery™ Elbow minimally constrained