The BFF Study- The Better to Fix or Fuse Study 'Retaining or Removing the Joint in the Foot: A Randomized Controlled Multicenter Trial of Primary Arthrodesis Versus Joint Stabilisation in Lisfranc Fracture Dislocation Midfoot Injuries
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- The 5 level EQ-5D version (EQ-5d-5L) questionnaire
研究概览
简要总结
The aim of the proposed study is to define the optimal treatment for Lisfranc fracture-dislocation, either primary arthrodesis (PA) or open reduction and internal fixation (ORIF), regarding the quality of life, complications, functional outcomes, and cost-effectiveness. The investigators hypothesize that patients will have a better quality of life and fewer complications during follow-up when undergoing a PA for unstable fracture-dislocations in the Lisfranc midfoot joints compared to ORIF. Further, the investigators expect this approach to be more cost-effective than the operative stabilization with retaining the dislocated joints, as patients will be exposed to a reduced number of reinterventions and hospital stay and/or prolonged use of pain medication.
详细描述
SUMMARY
Rationale: The Lisfranc injury is a complex injury of the midfoot. It can result in persistent pain and functional impairment if treated inappropriately. In Lisfranc fracture-dislocation treatment options are primary arthrodesis of the midfoot joints or open reduction and internal fixation with retaining of the midfoot joints.
Objective: The aim of the proposed study is to define optimal treatment for the Lisfranc fracture-dislocation, either primary arthrodesis or open reduction and internal fixation, in regard to the quality of life, complications, functional outcomes and cost-effectiveness. The investigators hypothesize that patients will have a better quality of life and fewer complications during follow-up when undergoing a PA for unstable fracture-dislocations in the Lisfranc midfoot joints compared to ORIF. Further, the investigators expect this approach to be more cost-effective than the operative stabilization with retaining the dislocated joints, as patients will be exposed to a reduced number of reinterventions and hospital stay and/or prolonged use of pain medication.
Study design: A multicenter prospective randomized controlled clinical trial. Study population: All patients from 18 years and older with an acute (<6 weeks) traumatic fracture-dislocation in the Lisfranc midfoot joints, displaced or unstable with weight-bearing radiographs, and are eligible for either one of the surgical procedures. In total, this study will include n=112 patients with Lisfranc fracture-dislocation.
Intervention (if applicable): Patients with Lisfranc fracture-dislocation will be randomly allocated to treatment with either PA or ORIF.
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
- 是
入选标准
- •Aged ≥18 years
- •Acute Lisfranc fracture injury (< 6 weeks after trauma)
- •Displaced or unstable with weight-bearing radiographs
- •Independent for activities of daily living (yes/no question)
排除标准
- •Open Lisfranc injury
- •Pure ligamentous Lisfranc injury
- •Non-displaced and stable with weight-bearing radiographs
- •Contra-indications for general or locoregional anesthetic techniques
- •Other fractures at the ipsilateral leg
- •Pre-existent abnormalities at the Lisfranc complex
- •Pre-existent immobility
- •Dependent on activities of daily living (due to dementia, Alzheimer, NYHA class IV angina and heart failure, oxygen-dependent COPD)
- •Rheumatoid arthritis
- •Pathologic fractures (metastasis, secondary osteoporosis)
- •Peripheral neuropathy and/or diabetes
- •Alcohol- or drug abuse preventing adequate follow-up
结局指标
主要结局
The 5 level EQ-5D version (EQ-5d-5L) questionnaire
时间窗: 2-year follow up period
This validated questionnaire (as defined by the EQ-5D-5L questionnaire) is a descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. When the patients has no problems at the dimension, f.e. mobility, this is coded as "1". LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/extreme problems
次要结局
- 12-Item Short Form Health Survey (SF-12)(2- year follow up period)
- American Orthopaedic Foot and Ankle Society Score (AOFAS)(2 year follow up period)
- Alignment of the foot on weight-bearing X-rays(2 year follow up period)
- Medical Consumption Questionnaire (MCQ)(2 year follow up period)
- Occurrence of complications(2 year follow up period)
- Foot And Ankle Disability Index (FADI)(2 year follow up period)
- Productivity Cost Questionnaire (PCQ)(2-year follow up period)