Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles. A Single Blinded Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Manchester Oxford Foot and Ankle Questionnaire
研究概览
简要总结
The purpose of this study is to compare the postoperative results after ORIF (Open Reduction Inner Fixation) with a partial weight-bearing protocol versus an early full weight-bearing protocol. But in addition, we will measure every patient's actual load by the means of walker integrated bio-feedback insoles for the first six postoperative weeks to record the adherence to the protocol.
详细描述
This study aims to compare the postoperative results after PWB (partial weight bearing) and early FWB (full weight bearing) and to show, that documented early protected weight-bearing after surgical fixation of unstable ankle fractures leads to an improved early clinical outcome and a faster return to work compared to PWB. It also aims to show, that an early FWB is safe in terms of complication rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with surgically stabilized unstable ankle fractures
- •signed informed consent
- •closed tibial and fibular epiphysis
- •age 18 or older
排除标准
- •dementia and other known cognitive impairment or incapacity of judgement
- •polytrauma
- •bilateral injury of the lower extremities
- •additional injury of the ipsilateral lower extremity which prevents full weight bearing
- •associated injury of one or both upper extremities
- •open fractures grade II° and III°
- •chronic loss of sensation on plantar aspect of the feet due to known distal neuropathy
- •open epiphysis
- •pregnancy
结局指标
主要结局
Manchester Oxford Foot and Ankle Questionnaire
时间窗: 1 year
Patient reported Outcome measure
次要结局
- Secondary dislocation of fracture(6 weeks)
- other PROMs (patient reported outcome measures)(1 year)
- Range of Motion(1 year)
研究者
Primoz Potocnik
Dr. med. Primoz Potocnik
Cantonal Hospital of St. Gallen