Clinical and Radiological Evaluation in Patients With Total Ankle Replacement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- survivorship
研究概览
简要总结
Numerous studies reported the efficacy of new third-generation of total ankle arthroplasties for the treatment of advanced ankle osteoarthritis and clinical results are comparable to ankle arthrodesis. The improvement in knowledge of ankle joint biomechanics, instrumentation, surgical approach may led to even higher clinical results in comparison to arthrodesis.
Many of the studies reporting the results of ankle replacement are provided by surgeons involved at least in the initial design of the implant. Thus, familiarity with the system can be a potential bias affecting outcomes and orthopedic surgeons may find difficulties in reproducing the results.
In this study, we will assess the clinical and radiological outcomes in patients who underwent this procedure performed by non-designer surgeons
详细描述
Patients who underwent total ankle replacement will be unrolled in this study. Clinical assessment is collected pre- and post-operatively with minimum follow-up of 12 months from each patients using the American Orthopedic Foot and Ankle (AOFAS) score, the Foot Function Index and the visual analogue scale (VAS) for pain.
Weightbearing anteriorposterior and lateral radiographs of the ankle are collected pre-operatively and at the last follow-up for all of the patients and independently evaluated by an orthopedic surgeon.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients treated with ankle replacement for osteoarthritis
- •The patient is willing and able to complete scheduled follow-up evaluations questionnaires and radiographic examination as described in the Informed Consent
排除标准
- •patients without radiographic follow-up
结局指标
主要结局
survivorship
时间窗: 10 years
Survival of the implants after 10 years which is based on removal of the components and will be assessed using the Kaplan Meier Method
次要结局
- angle a(10 years)
- angle b(10 years)
- angle y(10 years)
- offset ratio(10 years)
- AOFAS score(10 years)
- Foot function Index(10 years)