Post Operative Evaluation of Quality of Life and Pain in Ankle Fractures: Cast Immobilisation Versus Functional Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- pain
研究概览
简要总结
Rationale: Ankle fractures are common traumatic lesions. In order to restore the anatomical situation of the ankle joint to prevent posttraumatic arthritis, these fractures often need surgical treatment. Both cast immobilisation and functional treatment have proved to be reliable postoperative treatment regimes. Insight into the quality of life and the level of pain is necessary to determine if these treatments can be related to higher patient satisfaction and earlier resumption of daily activities and work.
Objective: The aim of this study is to examine two postoperative treatments for surgically corrected ankle fractures. Postoperative, direct functional mobilisation is compared to short term plaster cast fixation. The focus of this study is on quality of life, pain and the use of pain medication, and resumption of work and daily activities.
Main study parameters/endpoints:
Quality of life, Function, pain, swelling, daily activities and work, disabilities (pain disability index), complications
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
- Double (Investigator, Outcomes Assessor)
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
- •Age 18-65 at the time of surgery
- •Ankle fractures needing operative correction
- •Weber type B or C, Lauge Hansen type supination-adduction, supination-external rotation and pronation-external rotation
- •Closed fractures
- •Postoperative stable for exercise
- •Operated at the University Medical Centre St Radboud, Nijmegen or Alysis Zorggroep, Rijnstate Hospital, Arnhem
排除标准
- •Open fractures
- •Fractures with complete dislocation of the ankle joint
- •Body Mass Index > 30
- •Previous ankle fracture on the affected side
- •Concomitant traumatic injuries reducing the ability for postoperative mobilization
- •Pre-existent use of pain medication, medication affecting fracture- and wound healing
- •Postoperative unstable for exercise
- •Co-morbidity: pain syndromes, Fontaine IIB, III and IV, symptomatic venous insufficiency, auto-immune disorders, rheumatic arthritis
结局指标
主要结局
pain
时间窗: 6 weeks
Visual Analog Pain Scale
Pain medication used
时间窗: 6 weeks
amount of pain medication used
次要结局
未报告次要终点