Status:
TERMINATED
A Clinical Investigation of the M2a- Taper™ Hip System
Lead Sponsor:
Biomet Orthopedics, LLC
Conditions:
Non-inflammatory Degenerative Joint Disease
Osteoarthritis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a- Taper™ Hip System
Eligibility Criteria
Inclusion
- 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:
- Osteoarthritis,
- Avascular Necrosis,
- Traumatic arthritis,
- Subcapital fracture,
- Legg Perthes,
- Slipped Capital Epiphysis,
- Fracture of the pelvis,
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2001
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00698633
Start Date
December 1 2001
End Date
December 1 2008
Last Update
June 21 2017
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