Prospective, Randomized Multi-center Study Comparing Function, Pain and Return to Work in Conservative Versus Surgical Treated Stable Lateral Malleolar Fractures
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Olerud-Molander Ankle Score (OMAS)
研究概览
简要总结
Ankle fractures are one of the most common fractures in adults resulting in hospital stays and inability to work. Instable or dislocated ankle fractures are mostly treated by surgery. Treatment of stable lateral ankle fractures is still discussed controversial. They can be treated conservatively as well as by surgery.
Furthermore, optimal aftercare is part of on-going discussion in both groups. Goal of any treatment is a fast, good functional outcome with pain free patients at low overall costs. Long-term results in terms of osteoarthritis should be kept in mind.
The investigators seek to compare conservative and operative treatment in stable lateral ankle fractures in a prospective, randomised trial.
The hypothesis is that there is no difference between conservative and surgically treated stable lateral malleolar fractures regarding pain, function, and return to the workplace.
详细描述
Ankle fractures are one of the most common fractures in adults resulting in hospital stays and inability to work. Instable or dislocated ankle fractures are mostly treated by surgery. Treatment of stable lateral ankle fractures is still discussed controversial. They can be treated conservatively as well as by surgery.
Furthermore, optimal aftercare is part of on-going discussion in both groups. Goal of any treatment is a fast, good functional outcome with pain free patients at low overall costs. Long-term results in terms of osteoarthritis should be kept in mind.
Primary study objective is the comparison of functional result after conservative versus operative treatment in stable lateral ankle fractures.
Secondary study objectives are the return to work, pain, and osteoarthritis. It is a prospective, randomised (site stratified block randomisation) multi-center clinical trial. The two treatment options are split in two study arms and compared to each other.
Measurements and procedures:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
- •Acute, stable lateral malleolar fracture
- •Definition of stable:
- •Less than 2mm dislocation in a.p., lateral and gravity-stress x-ray
- •Medial tibiotalar distance <4mm and difference <1mm compared to the superior clear space on the gravity-stress and weight bearing x-ray
- •No talar subluxation
- •No intraoperative instability (Hook-/Frick-Test)
- •Between 18 and 65 years old
- •Living in Switzerland
- •Cognitive and physic ability to follow the study protocol
排除标准
- •Instable fractures
- •Previous ipsilateral surgery on the ankle or foot
- •Pregnancy
- •Diabetes mellitus
- •Neurologic or vascular impairment
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Previous enrolment into the current study
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
结局指标
主要结局
Olerud-Molander Ankle Score (OMAS)
时间窗: after 12 weeks
The OMAS Score is a patient-reported scale from 0 (totally impaired) to 100 (completely unimpaired) to evaluate subjectively scored function after ankle fracture. It consists of 9 questions: pain (0 to 25), stiffness (0 to 10), swelling (0 to 10), stair climbing (0 to 10), running (0 to 5), jumping (0 to 5), squatting (0 to 5), use of supports (0 to 10), and work/activity level (0 to 20), with higher scores indicating better outcomes
次要结局
- The Visual Analogue Scale Foot and Ankle (VAS FA)(at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years)
- American Orthopedic Foot and Ankle Society Score (AOFAS)(at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years)
- Foot Function Index (FFI)(at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years)
- Return to work(at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years)
- Kellgren-Lawrence scale(at time of accident, within the first two weeks, after 6 and 12 weeks, after 1, 3 and 5 years)