NCT00957658已完成不适用
Accolade® TMZF® Study A Prospective, Post-market, Non-randomized, Multi-center Evaluation of the Accolade® TMZF® Hip Stem
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 22
- 主要终点
- Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain
研究概览
简要总结
The purpose of this study is to evaluate clinical and radiographic outcome data in patients implanted with the Accolade® TMZF® femoral stem.
详细描述
A prospective, post-market, multi-centered clinical evaluation of the Accolade® TMZF® hip stem device. All patients enrolled will receive the study device. All study patients will undergo a preoperative central Dual energy X-ray absorptiometry (DXA) scan to determine bone mineral density (BMD) values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is a candidate for a primary total hip replacement.
- •Patient has primary diagnosis of osteoarthritis (OA).
- •Male and non-pregnant female patients ages 18 to
- •Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
- •Patient willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
- •Patient capable of undergoing a pre-op central DXA (dual-energy x-ray absorptiometry) scan for a bone mineral density (BMD) reading.
排除标准
- •Patient has an active infection within the affected hip joint.
- •Patient requires a revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
- •Patient who is morbidly obese, Body Mass Index (BMI) >
- •Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
- •Patient has the following diagnosed systemic diseases: Paget's disease, renal osteodystrophy, lupus erythematosus, rheumatoid arthritis, metabolic bone disease and sickle cell anemia.
- •Patient is immunologically suppressed or receiving chronic steroids more than 30 days. Patients receiving oral or IV steroids within one month of surgery.
- •Patient is a prisoner.
研究组 & 干预措施
Accolade® TMZF® Hip Stem
Other
Accolade® TMZF® Hip Stem Study Device
干预措施: Accolade® TMZF® Hip Stem (Device)
结局指标
主要结局
Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain
时间窗: 2 years
次要结局
- Change in Harris Hip Score (HHS)(Preoperative, 2 and 5 years)
- Change in Lower Extremity Activity Scale (LEAS) Score(Preoperative, 2 and 5 years)
- Revision/Removal Rates(2 and 5 years)
- Percentage (%) of Hip Stems With Aseptic Loosening(5 years)
- Change in SF-12 Score(Preoperative, 2 and 5 years)
- PEQ (Patient Expectation Questionnaire) Overall Satisfaction(6 months, 1 year and 2 years)
- PEQ (Patient Evaluation Questionnaire) Percent Achievement(6 months, 1 year, 2 years)
- Acetabular Insert Wear(5 years)
- Wrist DXA Scan Analysis(5 years)
研究者
研究点 (22)
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