Comprehensive Assessment of Peroneal Tendon Injuries - Evaluation and Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- NRS
研究概览
简要总结
Patients with surgery of a peroneal tendon injury in Gothenburg, Sweden, will be randomized to one of two different postoperative protocols. Before and after surgery the patients will perform biomechanical evaluation and also fill out questionnaires including PROMs. All evaluations will be performed on both limbs.
详细描述
Patients admitted for surgery because of peroneal tendon injury will be randomized to one of two postoperative immobilization protocols. In group A the patients will use a cast for 6 weeks after surgery. In group B, the patients will use a cast for 3 weeks followed by a Air Stirrup for 3 weeks. The patients in group B will start unloaded range of motion 3 weeks after surgery. Both groups are allowed to weight-bear directly after surgery. The patients will be evaluated before and several times after surgery. Patient-reported outcome measures (PROMs) will be used to evaluate changes in patient quality of life between the two interventions. A biomechanical evaluation of the ankle, knee and hip kinematics and kinetics during walking, running and walking will also be performed before and repeatedly after surgery.
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
- •* Surgery of peroneal tendon rupture and/or rupture of ligament and/or rupture of retinacle
排除标准
- •Extensive surgery needed, such as for example heel osteotomy
- •Previous surgery in the affected area
- •Previous injury in the healthy foot/leg that impairs function
- •Neuromuscular disease
- •Impaired language comprehension
- •Age under 18
结局指标
主要结局
NRS
时间窗: Preoperative and 3 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months postoperative.
Pain will be graded using Numeric Rating Scale (NRS) ranging from 0 to 10, whereas 0 is corresponding to no pain and 10 is corresponding to the worst pain imaginable. Patients will be asked to select a corresponding number (0 - 10) to indicate the pain intensity they are experiencing during an average day, before taking the functional tests, during the tests and after taking the functional tests. In follow-ups that does not include any functional tests, the patients will only grade pain during an average day.
次要结局
- Calf circumference(Preoperative and 6 months, 12 months and 24 months postoperative.)
- Range of motion(Preoperative and postoperative at 6 weeks, 3 months, 6 months, 12 months and 24 months.)
- Balance(Preoperative and postoperative at 6 months, 12 months and 24 months.)
- Biomechanical evaluation(Preoperative and postoperative at 6 months, 12 months and 24 months.)
- Electromyography (EMG)(Preoperative and postoperative at 6 months, 12 months and 24 months.)
- Cutting test(Preoperative and postoperative at 6 months, 12 months and 24 months.)
- Heel-rise work test(Preoperative and postoperative at 6 months, 12 months and 24 months.)
- Background questions(Preoperative and 3 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months postoperative.)
- The Self-Reported Foot and Ankle Score (SEFAS)(Preoperative and postoperative at 6 months, 12 months and 24 months.)
- Foot and Ankle Outcome Score (FAOS)(Preoperative and postoperative at 6 months, 12 months and 24 months.)
- Physical Activity Scale (PAS)(Preoperative and postoperative at 6 months, 12 months and 24 months.)
- EuroQol- 5 Dimension (EQ-5D)(Preoperative and postoperative at 6 months, 12 months and 24 months.)