Status:
TERMINATED
A Clinical Investigation of the M2a- 38™ 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- 38™ Hip System
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00698503
Start Date
January 1 2002
End Date
December 1 2008
Last Update
June 21 2017
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