A Clinical Investigation of Recovery Following Hip Resurfacing or Total Hip Arthroplasty
Primary Purpose
Osteoarthritis, Rheumatoid Arthritis, Arthritis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hip Resurfacing System
M2a-Magnum™ Large Metal Articulation
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Functional Tests
Secondary Outcome Measures
Full Information
NCT ID
NCT00585988
First Posted
December 21, 2007
Last Updated
June 19, 2017
Sponsor
Biomet Orthopedics, LLC
1. Study Identification
Unique Protocol Identification Number
NCT00585988
Brief Title
A Clinical Investigation of Recovery Following Hip Resurfacing or Total Hip Arthroplasty
Official Title
Functional Recovery Following Hip Resurfacing or Total Hip Arthroplasty in Patients Matched By Age, Gender, and Activity Level
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Study Start Date
June 2007 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biomet Orthopedics, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Arthritis, Traumatic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Title
2
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Hip Resurfacing System
Intervention Description
This arm will utilize a hip resurfacing system.
Intervention Type
Device
Intervention Name(s)
M2a-Magnum™ Large Metal Articulation
Intervention Description
This arm will utilize the M2a-Magnum™ implant system.
Primary Outcome Measure Information:
Title
Functional Tests
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
A Clinical Investigation of Recovery Following Hip Resurfacing or Total Hip Arthroplasty
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