Official Title: “A Prospective, Non-Controlled, Clinical Investigation of the M2a-Magnum™ Hip System”

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

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: November 2018

Arms, Groups and Cohorts in this Clinical Trial

• : M2a-Magnum™ Hip System

Primary Measures

• Harris Hip Score
  • Time Frame: 1 year, 3 years, 5 years, 10 years
    Safety Issue?: No
• X-rays
  • Time Frame: 1 year, 3 years, 5 years, 10 years
    Safety Issue?: No

Secondary Measures

• Incidence of revisions, removals, and/or complications
  • Time Frame: Any time
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Biomet Orthopedics, LLC

Overall Clinical Trial Officials and Contacts

Kenneth J Beres, MD Study Director Clinical Research, Biomet Orthopedics, LLC  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00698347

Study ID Number: Biomet 12380-82

ClinicalTrials.gov Identifier: NCT00698347

Health Authority: United States: Institutional Review Board