A Clinical Investigation of the M2a- Taper™ Hip System

NCT ID: NCT00698633

Last Updated: 2017-06-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2001-12-31
• Study Completion Date: 2008-12-31

Brief Summary

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

Conditions

Non-inflammatory Degenerative Joint Disease; Osteoarthritis; Avascular Necrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

M2a- Taper™ Hip System

M2a- Taper™ Hip System

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biomet Orthopedics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth J Beres, MD

Role: STUDY_DIRECTOR

Director, Clinical Research, Biomet Orthopedics, LLC

Other Identifiers

12380-5

Identifier Type: -

Identifier Source: org_study_id