A Prospective Randomized Controlled Monocentric Trial Evaluating the Effect of Biofeedback on Osseous Union Using Pedobarography After Mid- and Hindfoot Arthrodesis
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Evaluation of the influence of weight bearing an resting time on the development of osseous non-union after surgical arthrodesis at the level of the mid- and hindfoot.
研究概览
简要总结
The current study aims at evaluating the effect of biofeedback of correct partial weight bearing on the rate of osseous non-union compared to conventional patient instruction without biofeedback.
详细描述
Post-traumatic situations or instabilities of other aetiology at the level of the foot can lead to painful degenerative arthritis that necessitates surgical arthrodesis for pain relief. Surgical arthrodesis in this region though is associated with a high risk of osseous non-union (depending on the exact location up to 40%) despite standardized preparation and fixation techniques. The development of osseous non-union is associated with certain patient characteristics like active smoking, nutrition etc. Compliance to partial weight-bearing during the early postoperative phase is another contributing factor.
The current study aims at evaluating the effect of biofeedback of correct partial weight bearing on the rate of osseous non-union compared to conventional patient instruction without biofeedback.
All patients will postoperatively be provided with a lower- leg unloading orthosis furnished with a weight sensor that will - according to randomization - give feedback if a predefined weight threshold has been crossed or just measure weight-bearing without feedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Radiologists assessing the primary outcome osseous non-union will be blind to the treatment allocation.
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
- •Indication for hind- or midfoot arthrodesis
- •Informed Consent
- •Body weight < 90kg (according to Smartsens manufacturers recommendations)
排除标准
- •Physical or mental inability to follow weight-bearing recommendations (e.g. dementia, neurologic disease, upper extremity pathology)
- •Participation in a potentially interfering interventional trial during the last 30 day or before wash-out of any trial medication (e.g. steroids, medications affecting bone metabolism etc.)
- •Previous infection at the intended surgical site
- •Body weight > 90kg
- •Pregnancy
结局指标
主要结局
Evaluation of the influence of weight bearing an resting time on the development of osseous non-union after surgical arthrodesis at the level of the mid- and hindfoot.
时间窗: 3 months
The primary outcome is an analysis of the rate of non-unions after mid- and hindfoot arthrodesis comparing a sensor the two patient arms with activated vs non-activated biofeedback. The rate of osseous non-unions defined as CT-morphologic union \<30% of the joint surface at 3 months in relation to the provision of biofeedback.
次要结局
- Consumption of analgesic medication after surgery(12 months)
- Compliance i.e. adherence to weight bearing recommendations (≤ 15kg charge) with and without biofeedback.(6 weeks)
- Compliance i.e. adherence to resting time recommendations (≥ 80% of time) with and without biofeedback.(6 weeks)
- Patient's quality of life after surgery(12 months)
- Patient's satisfaction(12 months)
研究者
Prof. Dr. med. Arno Frigg
Prof. Dr. med.
Klinik Hirslanden, Zurich