A Clinical Investigation of Recovery Following Hip Resurfacing or Total Hip Arthroplasty

This study has been withdrawn prior to enrollment.

First Received on December 21, 2007. Last Updated on February 3, 2010 History of Changes

Sponsor:	Biomet Orthopedics, LLC
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00585988

Purpose

The primary purpose of this study is to compare early functional outcomes in patients undergoing hip resurfacing and total hip arthroplasty with the M2a-Magnum™ using more objective measures of function.

Condition	Intervention
Osteoarthritis Rheumatoid Arthritis Arthritis Traumatic Arthritis	Device: Hip Resurfacing System Device: M2a-Magnum™ Large Metal Articulation

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Functional Recovery Following Hip Resurfacing or Total Hip Arthroplasty in Patients Matched By Age, Gender, and Activity Level

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Functional Tests [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	June 2007
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Device: Hip Resurfacing System This arm will utilize a hip resurfacing system.
2	Device: M2a-Magnum™ Large Metal Articulation This arm will utilize the M2a-Magnum™ implant system.

Eligibility

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

Criteria

Inclusion Criteria:

Patients requiring hip arthroplasty

Exclusion Criteria:

Patients with sensory, neurological, or general health conditions that alter perception of their limb in space
Patients with vestibular disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585988

Locations

United States, Indiana
Biomet Orthopedics, Inc.
Warsaw, Indiana, United States, 46581

Sponsors and Collaborators

Biomet Orthopedics, LLC

More Information

No publications provided

Responsible Party:	Kenneth J. Beres, MD, Director of Clinical Research, Biomet Orthopedics, Inc.
ClinicalTrials.gov Identifier:	NCT00585988 History of Changes
Other Study ID Numbers:	292-U-010
Study First Received:	December 21, 2007
Last Updated:	February 3, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012