A Clinical Investigation of the M2a-Magnum™ Hip System

Terminated

• Conditions: Rheumatoid Arthritis; Osteoarthritis, Hip; Arthritis; Joint Disease; Bone Disease
• Interventions: Device: M2a-Magnum™ Hip System

• Registration Number: NCT00698347
• Lead Sponsor: Biomet Orthopedics, LLC

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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-13
• Study First Posted: 2008-06-17
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 249

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
M2a-Magnum™ Hip System	M2a-Magnum™ Hip System	Patients who received the M2a-Magnum™ Hip System

Primary Outcome Measures

Name	Time	Method
Harris Hip Score	10 years

Secondary Outcome Measures

Name	Time	Method
Incidence of revisions, removals, and/or complications	Any time
X-Rays	10 years