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A Clinical Investigation of the Discovery™ Elbow System
This study is enrolling participants by invitation only.
First Received: June 13, 2008   Last Updated: January 8, 2009   History of Changes
Sponsored by: Biomet Orthopedics, LLC
Information provided by: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00698867
  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

MedlinePlus related topics: Fractures Osteoarthritis Osteonecrosis Rheumatoid Arthritis
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: A Prospective, Non-Controlled, Clinical Investigation of the Discovery™ Elbow System

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • ASES Assessment [ Time Frame: 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ] [ Designated as safety issue: No ]
  • X-rays [ Time Frame: 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of revision or removals [ Time Frame: Any time ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 400
Study Start Date: June 2002
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Discovery™ Elbow
Discovery™ Elbow

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698867

Sponsors and Collaborators
Biomet Orthopedics, LLC
Investigators
Study Director: Kenneth J Beres, MD Director, Clinical Research, Biomet Orthopedics, LLC
  More Information

No publications provided

Responsible Party: Biomet Orthopedics, LLC ( Kenneth Beres, MD. Director Clinical Research )
Study ID Numbers: Biomet 12381-8
Study First Received: June 13, 2008
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00698867     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
Total Elbow Arthroplasty
Total Elbow Replacement
Osteoarthritis
Elbow arthritis

Study placed in the following topic categories:
Autoimmune Diseases
Osteonecrosis
Osteoarthritis
Joint Diseases
Fractures, Bone
Wounds and Injuries
Arthritis, Rheumatoid
Disorders of Environmental Origin
Humeral Fractures
Rheumatic Diseases
Bone Diseases
Arm Injuries
Necrosis
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases

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

ClinicalTrials.gov processed this record on May 07, 2009