Midfoot Fusion Bolt (MFB). A Randomized Controlled Multicenter Study to Assess the Effectiveness of Surgical Treatment With Midfoot Fusion Bolt in the Early Stage of Diabetic-neuropathic Charcot Feet
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- treatment failure rate
研究概览
简要总结
Randomized clinical trial (RCT) to compare treatment failure rates of surgical arthrodesis with MFB against cast treatment in patients suffering from early stage Charcot neuroarthropathy (CN) of the midfoot (Sella and Barrette stages 0, 1 or 2) within the first 2 years after initial treatment. Treatment failure is defined as the occurrence of one or more of the following: 1. Amputation, 2. Occurrence of ulcer or worsening of existing ulcer, 3. Surgical intervention for correction of deformity after initial treatment. The secondary aims are to compare foot function, radiologic outcome, quality of life, complications and foot temperature between the two groups.
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
- None
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
- •Age > 18 years
- •Patients with Diabetes Mellitus Type I or II
- •CN stages 0, 1 or 2 of the midfoot (Sella and Barrette classification)
- •Willingness and ability to participate in the study follow-up according to the protocol
- •Ability to understand and read local language at elementary level
- •Signed informed consent
排除标准
- •Legal incompetence
- •Previous Charcot foot on the affected side
- •Active osteomyelitis in the affected foot
- •Above knee amputation on the contralateral side
- •Patient health status not adequate for surgery
- •Active malignacy
- •Severe peripheral arterial disease (ankle-brachial index <0.7 or absent digital waveforms on Doppler)
- •Ulcer grade 2 or more on the Wagner classification system
- •Alcohol or drug abuse
- •Life-threatening co-morbidities
结局指标
主要结局
treatment failure rate
时间窗: baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Treatment failure is defined as the occurrence of one or more of the following: 1. Amputation 2. Occurrence of ulcer or worsening of existing ulcer (according to Wagner classification) 3. Surgical intervention for correction of deformity after initial treatment
次要结局
- Radiologic outcome(baseline, 12 weeks, 12 months)
- Foot temperature(baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months)
- Rate of complications(baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months)
- Evaluation of the generic quality of life including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression(baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months)
- Foot function(baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months)