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A Clinical Investigation of the M2a-Magnum™ Hip System

Sponsor
Biomet Orthopedics, LLC (Industry)
Overall Status
Terminated
CT.gov ID
NCT00698347
Collaborator
(none)
249
Enrollment
122
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a-Magnum™ Hip System

Condition or Disease Intervention/Treatment Phase
  • Device: M2a-Magnum™ Hip System

Detailed Description

This is a 10 year prospective data collection documenting the function and survivorship of the M2a-Magnum™ Hip System. Patients are required to come in for preoperative, operative, one year follow-up, three year follow-up, five year follow-up, and ten year follow-up exams.

This product was FDA cleared in 2004.

Study Design

Study Type:
Observational
Actual Enrollment :
249 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective, Non-controlled, Clinical Investigation of the M2a-Magnum™ Hip System
Study Start Date :
Nov 1, 2004
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

Arm Intervention/Treatment
M2a-Magnum™ Hip System

Patients who received the M2a-Magnum™ Hip System

Device: M2a-Magnum™ Hip System
Other Names:
  • Magnum Hip

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Harris Hip Score [10 years]

    Secondary Outcome Measures

    1. Incidence of revisions, removals, and/or complications [Any time]

    2. X-Rays [10 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Non-inflammatory degenerative joint disease including: Avascular Necrosis, Diastrophic Variant, Fracture of the Pelvis, Fused Hip, Leg Perthes, Osteoarthritis, Slipped Capital Epiphysis, Subcapital Fractures, Traumatic Arthritis

    • Rheumatoid Arthritis

    • Correction of Functional Deformity

    • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques

    • Revision of previously failed total hip arthroplasty

    Exclusion Criteria:
    Absolute contraindications include:
    • Infection, Sepsis, and Osteomyelitis
    Relative contraindications include:

    • Uncooperative patient or patient with neurologic disorders that are incapable of following directions

    • Osteoporosis

    • Metabolic disorders which may impair bone formation

    • Osteomalacia

    • Distant foci of infections which may spread to the implant site

    • Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram

    • Vascular insufficiency, muscular atrophy, or neuromuscular disease

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Biomet Orthopedics, LLC

    Investigators

    • Study Director: Russell Schenck, PhD, Clinical Research, Biomet Orthopedics, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biomet Orthopedics, LLC
    ClinicalTrials.gov Identifier:
    NCT00698347
    Other Study ID Numbers:
    • Biomet 12380-82
    First Posted:
    Jun 17, 2008
    Last Update Posted:
    Jun 21, 2017
    Last Verified:
    Jun 1, 2017
    Keywords provided by Biomet Orthopedics, LLC
    Total Knee Replacement
    Total Knee Arthroplasty
    Hip Arthritis
    Additional relevant MeSH terms:
    Arthritis
    Joint Diseases
    Bone Diseases
    Osteoarthritis, Hip

    Study Results

    No Results Posted as of Jun 21, 2017