Discovery Elbow Multi-Center Prospective Study

Condition(s) targeted: Elbow Replacement

Intervention: Discovery Elbow replacement (Device)

Phase: N/A

Status: Recruiting

Sponsored by: Vanderbilt University

Official(s) and/or principal investigator(s):
Donald H Lee, MD, Principal Investigator, Affiliation: Vanderbilt University

Overall contact:
Julie M Daniels, BBA, Email: julie.m.daniels@vanderbilt.edu

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

Official title: Discovery Elbow Multi-Center Prospective Study

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment

Primary outcome: Patient examination measurements and radiographic measurements will be used to determine the effects of the Discovery Elbow implant

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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:

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.

Julie M Daniels, BBA, Email: julie.m.daniels@vanderbilt.edu

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

Starting date: May 2007
Ending date: May 2010
Last updated: August 5, 2009