Status:
TERMINATED
A Clinical Investigation of the M2a-Magnum™ Hip System
Lead Sponsor:
Biomet Orthopedics, LLC
Conditions:
Osteoarthritis, Hip
Arthritis
Eligibility:
All Genders
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT00698347
Start Date
November 1 2004
End Date
January 1 2015
Last Update
June 21 2017
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