A Clinical Investigation of the Discovery™ Elbow System - Full Text View

Sponsor:	Biomet Orthopedics, LLC
Information provided by (Responsible Party):	Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:	NCT00698867

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:

MedlinePlus related topics: Fractures Osteoarthritis Osteonecrosis Rheumatoid Arthritis

U.S. FDA Resources

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 functioncompliled 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

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

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
The Indiana Hand 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
Other Study ID Numbers:	Biomet 12381-8
Study First Received:	June 13, 2008
Last Updated:	December 2, 2011
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
Necrosis
Osteonecrosis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arm Injuries
Wounds and Injuries
Fractures, Bone
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on February 09, 2012