Avascular Necrosis, Non-inflammatory Degenerative Joint Disease, Osteoarthritis
Conditions
Keywords
Metal on Metal, Total Hip Arthroplasty, Total Hip Replacement
Brief summary
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a- 38™ Hip System
Interventions
None listed
Sponsors
Biomet Orthopedics, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Harris Hip Score | 12 weeks, 1 year, 3 years, 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of revisions and removals | Any time |
Outcome results
None listed