A Clinical Investigation of the M2a- 38™ Hip System
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ClinicalTrials.gov Identifier: NCT00698503
(due to low follow up)
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients that have already made the decision to undergo Total Hip Replacement and will receive the M2a- 38™ Hip System
Patients having primary cemented or cementless total hip replacement for non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnosis 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 preoperative total Harris Hip Score less than 70 with at least moderate pain.
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 preclude 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.