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A Clinical Investigation of the Discovery™ Elbow System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00698867
First Posted: June 17, 2008
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )
  Purpose
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.

Condition
Osteoarthritis Rheumatoid Arthritis Avascular Necrosis Humeral Fractures

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-controlled, Clinical Investigation of the Discovery™ Elbow System

Resource links provided by NLM:


Further study details as provided by Zimmer Biomet ( Biomet Orthopedics, LLC ):

Primary Outcome Measures:
  • American Shoulder and Elbow Society Score (ASES) Pain Assessment [ Time Frame: 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 [ Time Frame: 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.

  • Patient Derived American Shoulder and Elbow Society Score (ASES) Satisfaction [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Secondary Outcome Measures:
  • Incidence of Surviving Elbows [ Time Frame: Up to 5 Years ]
    Proportion of elbows that did not require revision or removal


Enrollment: 118
Study Start Date: June 2002
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Discovery™ Elbow
Discovery™ Elbow minimally constrained

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in need of relief from painful or disabling Joint Disease in need of total elbow replacment.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698867


Locations
United States, Florida
Florida Orthopedic Institute
Tampa, Florida, United States, 33637
United States, Indiana
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States, 46260
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Tennessee
Vanderbilt Hand Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Biomet Orthopedics, LLC
Investigators
Study Director: Russell Schenck, PhD Director, Clinical Research, Biomet Orthopedics, LLC
  More Information

Responsible Party: Biomet Orthopedics, LLC
ClinicalTrials.gov Identifier: NCT00698867     History of Changes
Obsolete Identifiers: NCT00515515
Other Study ID Numbers: ORTHO.CR.EX001
First Submitted: June 13, 2008
First Posted: June 17, 2008
Results First Submitted: September 20, 2016
Results First Posted: August 7, 2017
Last Update Posted: August 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Zimmer Biomet ( Biomet Orthopedics, LLC ):
Total Elbow Arthroplasty
Total Elbow Replacement
Osteoarthritis
Elbow arthritis

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Necrosis
Humeral Fractures
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Arm Injuries
Wounds and Injuries
Fractures, Bone