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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Withdrawn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
Biomet Orthopedics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 21, 2007
    Last Updated
    June 19, 2017
    Sponsor
    Biomet Orthopedics, LLC
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    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    Withdrawn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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