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This study has been withdrawn prior to enrollment.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
  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:


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

ClinicalTrials.gov processed this record on August 19, 2014