A Clinical Investigation of the Discovery™ Elbow System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00698867
First received: June 13, 2008
Last updated: July 30, 2014
Last verified: December 2013
  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 Biomet, Inc.:

Primary Outcome Measures:
  • ASES Assessment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Evaluation of pain and function compiled by the Patient ASES scores Evaluation of signs,stability, strength and range of motion from the Physician ASES scores


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

Estimated Enrollment: 120
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 minimally constrained

Detailed Description:

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

  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 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
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, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00698867     History of Changes
Obsolete Identifiers: NCT00515515
Other Study ID Numbers: Biomet 12381-8
Study First Received: June 13, 2008
Last Updated: July 30, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014