Official Title: “M2a- Taper™ Hip System Prospective Data Collection”

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

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: April 2009

Arms, Groups and Cohorts in this Clinical Trial

• : M2a- Taper™ Hip System
  • M2a- Taper™ Hip System

Primary Measures

• Harris Hip Score
  • Time Frame: Postop, 12 weeks, 1 year, 3 years, 5 years
    Safety Issue?: No

Secondary Measures

• Incidence of revisions and removals
  • Time Frame: Any time
    Safety Issue?: Yes

Inclusion Criteria:

• Patients having primary cemented or cementless total hip replacement for non-inflammatory degenerative joint disease (NIDJD), or any of its composite diagnoses of:
• 1. Osteoarthritis, 2. Avascular Necrosis, 3. Traumatic arthritis, 4. Subcapital fracture, 5. Legg Perthes, 6. Slipped Capital Epiphysis, 7. Fracture of the pelvis, 8. Diastrophic Variant
• Patients with full skeletal maturity.
• Patients undergoing unilateral total hip arthroplasty or bilateral total hip arthroplasty, either staged or simultaneously.
• Patients of all races and gender.
• Patients who are able to follow postoperative care instructions.
• Patients who are able and willing to return for follow-up evaluations.
• Patients have a preoperative total Harris Hip Score less than 70 with at least moderate pain.

Exclusion Criteria

• Patients diagnosed with inflammatory degenerative arthritis (IDJD) to include the following composite diagnoses: rheumatoid arthritis, systemic lupus erythematous, pigmented villonodular synovitis, juvenile rheumatoid arthritis and other arthritic processes of inflammatory or autoimmune etiology.
• Patients less than 18 years.
• Patients with the presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the hip joint to be operated.
• Patients with previous Girdlestone procedures.
• Patients with above the knee amputation of the contralateral and/or ipsilateral leg.
• Patients with osteoporosis, or marked bone loss which would preclude proper fixation of the prosthesis.
• Patients who are pregnant.
• Patients with an active or suspected infection in or around the hip.
• Patients with Parkinson's disease.
• Patients with vascular insufficiency, muscular atrophy, or neuromuscular disease in the affected limb.
• Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue which would prelude stability of the prosthesis.
• Patients with a highly communicable disease or diseases that may limit follow-up (e.g.
• immuno-compromised conditions, hepatitis, active tuberculosis, neoplastic disease, etc.).
• Patients unwilling or unable to comply with a rehabilitation program for a cemented or cementless total hip replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
• Patients with previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome, e.g., Paget's disease, Charcot's disease, severe osteoporosis compromising bone stock (Dorr type C bone).
• Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
• Patients with a "fused" hip.
• Patients who have had a total hip arthroplasty on the contralateral hip within the last year.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

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 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/NCT00698633

Study ID Number: 12380-5

ClinicalTrials.gov Identifier: NCT00698633

Health Authority: United States: Institutional Review Board