Discovery Elbow Multi-Center Prospective Study - Full Text View

Sponsor:	Vanderbilt University
Collaborator:	Biomet, Inc.
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00515515

Purpose

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

Condition	Intervention
Elbow Replacement	Device: Discovery Elbow replacement

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Discovery Elbow Multi-Center Prospective Study

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	40
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Total elbow arthroplasty using discovery elbow replacement

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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: NCT00515515

Contacts

Contact: Julie M Daniels, BBA

julie.m.daniels@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt Hand Center	Recruiting
Nashville, Tennessee, United States, 37232-8828

Sponsors and Collaborators

Vanderbilt University

Biomet, Inc.

Investigators

Principal Investigator:

Donald H Lee, MD

Vanderbilt University

More Information

No publications provided

Responsible Party:	Vanderbilt University ( Dr. Donald Lee )
Study ID Numbers:	060092
Study First Received:	August 7, 2007
Last Updated:	August 5, 2009
ClinicalTrials.gov Identifier:	NCT00515515 History of Changes
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 08, 2010