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Completed

NCT Number: NCT00698867

A 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.

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Key information

Conditions

Osteoarthritis Arm Injuries Arthritis Arthritis, Rheumatoid Autoimmune Diseases Avascular Necrosis Bone Diseases Connective Tissue Diseases Fractures, Bone Humeral Fractures Immune System Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Florida Orthopedic Institute, Tampa, Florida, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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 outcomes

  1. Incidence of Surviving Elbows

    Time frame: Up to 5 Years

    Proportion of elbows that did not require revision or removal

Sponsors and collaborators

Lead sponsor

Biomet Orthopedics, LLC

Industry

Registry information

Official study title

A Prospective, Non-controlled, Clinical Investigation of the Discovery™ Elbow System

Important dates

Study start
2002
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2008
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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