NCT00698503终止不适用
M2a- 38™ Hip System Prospective Data Collection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 190
- 主要终点
- Harris Hip Score
研究概览
简要总结
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a- 38™ Hip System
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Harris Hip Score
时间窗: 12 weeks, 1 year, 3 years, 5 years
次要结局
- Incidence of revisions and removals(Any time)
研究者
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