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

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by (Responsible Party):

Biomet, Inc. ( Biomet Orthopedics, LLC )

ClinicalTrials.gov Identifier:

NCT00585988

First received: December 21, 2007

Last updated: June 27, 2012

Last verified: June 2012

History of Changes

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:

Genetics Home Reference related topics: 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 ]


Enrollment:	0
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

No publications provided


Responsible Party:	Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:	NCT00585988 History of Changes
Other Study ID Numbers:	292-U-010
Study First Received:	December 21, 2007
Last Updated:	June 27, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Arthritis Arthritis, Rheumatoid Osteoarthritis Autoimmune Diseases Connective Tissue Diseases	Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

ClinicalTrials.gov processed this record on February 25, 2015

To Top