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Discovery Elbow Multi-Center Prospective Study
This study is currently recruiting participants.
Study NCT00515515   Information provided by Vanderbilt University
First Received: August 7, 2007   Last Updated: August 5, 2009   History of Changes

August 7, 2007
August 5, 2009
May 2007
May 2010   (final data collection date for primary outcome measure)
Patient examination measurements and radiographic measurements will be used to determine the effects of the Discovery Elbow implant [ Time Frame: Pre-operative to Five year post-operative appointment ] [ Designated as safety issue: No ]
Patient examination measurements and radiographic measurements will be used to determine the effects of the Discovery Elbow implant [ Time Frame: Pre-operative to Five year post-operative appointment ]
Complete list of historical versions of study NCT00515515 on ClinicalTrials.gov Archive Site
 
 
 
Discovery Elbow Multi-Center Prospective Study
Discovery Elbow Multi-Center Prospective Study

The purpose of this prospective clinical trial is to document the performance and clinical outcomes of Biomet Discovery Elbow.

About 3 years ago, Biomet engineers began developing a completely different elbow system. They focused on problems of past elbow designs, including:

  • Poor anatomic stem design
  • Poorly reproduced elbow hinge mechanics
  • Unrefined, cumbersome instrumentation, difficult technique reproduction
  • Excess wear on hinge bearing
  • Low-grade polyethylene
  • Bearing difficult to service/revise
  • Poor preservation of bone around the hinge With these challenges in mind, the Discovery™ Elbow began to take form.

Discovery™ design goals:

  • Anatomic design
  • Restore joint mechanics
  • Long lasting hinge
  • Accurate, user-friendly instrumentation

The rationale behind the Discovery™ Elbow was to create a device that closely matches the anatomy, while providing a superior hinge mechanism that is easier to assemble and revise should it become necessary. It was also a priority to create an instrument set that was ideal for a broad range of surgeons.

 
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment
Elbow Replacement
Device: Discovery Elbow replacement
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
40
May 2010
May 2010   (final data collection date for primary outcome measure)

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:

  1. Need to obtain pain relief and improve function
  2. Ability and willingness to follow instructions including control of weight and activity levels.
  3. Patients who are able and willing to return for follow-up evaluations.
  4. Patients with a good nutritional state.
  5. Patients with full skeletal maturity.
  6. Patients of all races and gender.
  7. 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.
Both
18 Years and older
No
Contact: Julie M Daniels, BBA julie.m.daniels@vanderbilt.edu
United States
 
NCT00515515
Dr. Donald Lee, Vanderbilt University
060092
Vanderbilt University
Biomet, Inc.
Principal Investigator: Donald H Lee, MD Vanderbilt University
Vanderbilt University
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP