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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This study has been withdrawn prior to enrollment.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:

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
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
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013