A Clinical Investigation of the M2a-Magnum™ Hip System

Zimmer Biomet

Status: Terminated

Conditions: Osteoarthritis, Hip; Joint Disease; Arthritis; Bone Disease; Rheumatoid Arthritis

Treatments: Device: M2a-Magnum™ Hip System

Study type: Observational

Funder types: Industry

Identifiers

NCT00698347

Biomet 12380-82

Details and patient eligibility

About

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

Full 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.

Enrollment: 249 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

249 participants in 1 patient group

M2a-Magnum™ Hip System

Description:

Patients who received the M2a-Magnum™ Hip System

Treatment:

Device: M2a-Magnum™ Hip System