Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
249 participants
OBSERVATIONAL
2004-11-30
2015-01-31
Brief Summary
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Detailed Description
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This product was FDA cleared in 2004.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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M2a-Magnum™ Hip System
Patients who received the M2a-Magnum™ Hip System
M2a-Magnum™ Hip System
Interventions
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M2a-Magnum™ Hip System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Biomet Orthopedics, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Russell Schenck, PhD
Role: STUDY_DIRECTOR
Clinical Research, Biomet Orthopedics, LLC
Other Identifiers
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Biomet 12380-82
Identifier Type: -
Identifier Source: org_study_id
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