A Clinical Investigation of Recovery Following Hip Resurfacing or Total Hip Arthroplasty
This study has been withdrawn prior to enrollment.
Sponsor:
Biomet Orthopedics, LLC
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
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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
MedlinePlus related topics:
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 (Adult, Senior) |
| 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
No Contacts or Locations Provided
More Information
| Responsible Party: | 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 Osteoarthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on September 29, 2016