June 13, 2008 |
March 6, 2009 |
January 2002 |
Harris Hip Score [ Time Frame: 12 weeks, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ] |
Same as current |
Complete list of historical versions of study NCT00698503 on ClinicalTrials.gov Archive Site |
Incidence of revisions and removals [ Time Frame: Any time ] [ Designated as safety issue: Yes ] |
Same as current |
|
A Clinical Investigation of the M2a- 38™ Hip System |
M2a- 38™ Hip System Prospective Data Collection |
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a- 38™ Hip System |
|
|
Observational |
Cohort, Prospective |
- Non-Inflammatory Degenerative Joint Disease
- Osteoarthritis
- Avascular Necrosis
|
|
|
|
|
Terminated |
190 |
December 2008 |
December 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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 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 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.
|
Both |
18 Years and older |
No |
|
|
|
|
NCT00698503 |
Kenneth Beres, MD. Director Clinical Research, Biomet Orthopedics, LLC |
|
Biomet Orthopedics, LLC |
|
Study Director: |
Kenneth J Beres, MD |
Director, Clinical Research, Biomet Orthopedics, LLC |
|
|
Biomet, Inc. |
March 2009 |