A Clinical Investigation of the Discovery™ Elbow System

NCT00698867 | Completed Results

• 1 other identifier: ORTHO.CR.EX001
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 4

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.

Conditions

Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; Humeral Fractures

Keywords

Total Elbow Arthroplasty; Total Elbow Replacement; Osteoarthritis; Elbow arthritis

Outcome Measures

Primary Outcomes (6)

• American Shoulder and Elbow Society Score (ASES) Pain Assessment

  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.

  5 years

• Patient Derived American Shoulder and Elbow Society Score (ASES) Function

  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.

  5 Years

• Patient Derived American Shoulder and Elbow Society Score (ASES) Satisfaction

  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.

  5 Years

• Surgeon Derived American Shoulder and Elbow Society Score (ASES) Signs

  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.

  5 Years

• Surgeon Derived American Shoulder and Elbow Society Score (ASES) Stability

  Surgeon assessment of patient elbow stability. Maximum instability score is 9 and the minimum is 0. The maximum score indicates the least stability.

  5 Years

• Surgeon Derived American Shoulder and Elbow Society Score (ASES) Strength

  Measure of elbow strength as defined by the investigator. Maximum score is 20 and the minimum is 0. The maximum score indicates maximum strength.

  5 Years

Secondary Outcomes (1)

• Incidence of Surviving Elbows

  Up to 5 Years

Study Arms (1)

Discovery™ Elbow

Discovery™ Elbow minimally constrained

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 in need of relief from painful or disabling Joint Disease in need of total elbow replacment.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biomet Orthopedics, LLC: lead

Study Sites (4)

Florida Orthopedic Institute

Tampa, Florida, 33637, United States

Location

Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Vanderbilt Hand Center

Nashville, Tennessee, 37232, United States

Location

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

Results Point of Contact

• Title: Kelly Francher, Clinical Affairs Manager
• Organization: Zimmer Biomet

kelly.francher@zimmerbiomet.com

574-371-9783

Study Officials

• Russell Schenck, PhD

  Director, Clinical Research, Biomet Orthopedics, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: June 1, 2002
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 7, 2017
• Results First Posted: August 7, 2017

Record last verified: 2017-04

Locations

US (4)