A Clinical Investigation of the Discovery™ Elbow System

Completed

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

• Registration Number: NCT00698867
• Lead Sponsor: Biomet Orthopedics, LLC

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-13
• Study First Posted: 2008-06-17
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Results First Submitted: 2016-09-20
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-28
• Last Update Submitted: 2017-04-28
• Results First Posted: 2017-08-07
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Derived American Shoulder and Elbow Society Score (ASES) Satisfaction	5 Years	This is a measure of patient satisfaction as answered by the patient. The maximum score is 10 and the minimum is 0. The maximum score indicates maximum satisfaction.
Surgeon Derived American Shoulder and Elbow Society Score (ASES) Signs	5 Years	This is a measure of the elbow signs as reported by the investigator. Signs include various assessments of joint tenderness, impingement, and pain in range of motion. The maximum score is 39 and the minimum is 0. The maximum score indicates the most abnormal signs.
Surgeon Derived American Shoulder and Elbow Society Score (ASES) Stability	5 Years	Surgeon assessment of patient elbow stability. Maximum instability score is 9 and the minimum is 0. The maximum score indicates the least stability.
Surgeon Derived American Shoulder and Elbow Society Score (ASES) Strength	5 Years	Measure of elbow strength as defined by the investigator. Maximum score is 20 and the minimum is 0. The maximum score indicates maximum strength.
American Shoulder and Elbow Society Score (ASES) Pain Assessment	5 years	This is a patient reported outcome measure that indicates the patient's pain as measured on the ASES form. The maximum pain score is 50 and the minimum score is 0. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.
Patient Derived American Shoulder and Elbow Society Score (ASES) Function	5 Years	This is a measure of patient function as answered by the patient. The maximum score is 36 and the minimum is 0. The maximum score represents maximum function.

Secondary Outcome Measures

Name	Time	Method
Incidence of Surviving Elbows	Up to 5 Years	Proportion of elbows that did not require revision or removal

Trial Locations

Locations (4)

Vanderbilt Hand Center; 🇺🇸 Nashville, Tennessee, United States

Florida Orthopedic Institute; 🇺🇸 Tampa, Florida, United States

Indiana Hand to Shoulder Center; 🇺🇸 Indianapolis, Indiana, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States