NCT00698347
Terminated
N/A
A Prospective, Non-controlled, Clinical Investigation of the M2a-Magnum™ Hip System
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Hip
- Sponsor
- Biomet Orthopedics, LLC
- Enrollment
- 249
- Primary Endpoint
- Harris Hip Score
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Harris Hip Score
Time Frame: 10 years
Secondary Outcomes
- Incidence of revisions, removals, and/or complications(Any time)
- X-Rays(10 years)
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