A Clinical Investigation of the Discovery™ Elbow System

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 Overview

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

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 118

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33637
      • Florida Orthopedic Institute
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Indiana Hand to Shoulder Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Hand Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Discovery™ Elbow; Discovery™ Elbow minimally constrained

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Surviving Elbows	Proportion of elbows that did not require revision or removal	Up to 5 Years

Collaborators and Investigators

• Sponsor: Biomet Orthopedics, LLC
• Investigators: Study Director: Russell Schenck, PhD, Director, Clinical Research, Biomet Orthopedics, LLC

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: June 13, 2008
• First Submitted That Met QC Criteria: June 13, 2008
• First Posted (Estimate): June 17, 2008

Study Record Updates

• Last Update Posted (Actual): August 7, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Osteoarthritis; Total Elbow Arthroplasty; Total Elbow Replacement; Elbow arthritis
• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arm Injuries; Arthritis; Osteoarthritis; Necrosis; Humeral Fractures
• Other Study ID Numbers: ORTHO.CR.EX001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED