Avascular Necrosis, Non-inflammatory Degenerative Joint Disease, Osteoarthritis
Conditions
Keywords
Hip arthroplasty
Brief summary
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a- Taper™ 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 diagnoses of: 1. Osteoarthritis, 2. Avascular Necrosis, 3. Traumatic arthritis, 4. Subcapital fracture, 5. Legg Perthes, 6. Slipped Capital Epiphysis, 7. Fracture of the pelvis, 8. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Harris Hip Score | Postop, 12 weeks, 1 year, 3 years, 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of revisions and removals | Any time |
Outcome results
None listed