A Clinical Investigation of the Discovery™ Elbow System

Rheumatoid Arthritis Clinical Trial

Official title:

A Prospective, Non-controlled, Clinical Investigation of the Discovery™ Elbow System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00698867
• Other study ID #: ORTHO.CR.EX001
• Status: Completed
• Phase: N/A
• First received: June 13, 2008
• Last updated: July 14, 2016
• Start date: June 2002
• Est. completion date: July 2016

Study information

• Verified date: July 2015
• Source: Biomet, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Other known NCT identifiers

• NCT00515515

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis
• Humeral Fractures
• Necrosis
• Osteoarthritis
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Indiana Hand to Shoulder Center	Indianapolis	Indiana
United States	Vanderbilt Hand Center	Nashville	Tennessee
United States	Florida Orthopedic Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biomet Orthopedics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ASES Assessment	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	5 years	No
Secondary	Incidence of revision or removals		Any time	Yes