Does Performing a Composite Test 3 Months Post-operatively Reduce the Risk of Failure to Return to Sport After Lateral Ankle Ligamentoplasty?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- 1-year post-surgery return to sport : Tegner questionnaire
研究概览
简要总结
Ankle sprain is one of the most common pathologies in the general population (between 2.1 and 3.2 per 1000 patients per year). Nearly 40% of patients will develop chronic instability in the year following the sprain. We also know that a premature return to sport is a risk factor for developing chronic instability. However, despite the consensus of experts on the subject which have shown the key physiological elements to evaluate before resuming sport, no test or cohort of tests are proposed to allow a safe return to sport by reducing the risks of relapse. Some very recent studies have appeared on non-operated subjects but this remains a subject that is still too little studied, where the lack of consensus and objective criteria increases the risk of instability. Surgical treatment remains an effective option to reduce the risk of recurrence but failure of the latter can occur in approximately 13-37% of patients depending on the population, due to a relapse or a return to sport which does not correspond to expectations. of the patient.
The objective of the study is therefore to evaluate the predictive nature of a composite test (ANKLE-GO) regarding the return to sport at the same level and the risks of recurrence.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with objective chronic ankle instability who has failed medical treatment and undergone lateral ankle ligament repair surgery
- •Patient practicing a sporting activity at least 2 times a week
- •Patient able to read, write and understand French
- •Patient affiliated to a social security scheme
排除标准
- •Minor or over 50 years of age
- •Pregnant or breast-feeding patient
- •Patient under guardianship, deprived of liberty or under court protection
- •Refusal to participate in research
- •Patient unable to understand or give informed consent
- •Patient having undergone associated surgical procedures modifying the postoperative course
- •Patient having undergone revision surgery
研究组 & 干预措施
Personnalized physiotherapy
Following completion of the ankle go test, patients in "experimental" group will receive specific instructions for continuing their rehabilitation, which will be passed on to the physiotherapist in charge of their rehabilitation.
These instructions will be adapted according to the results of the composite test and the items identified. The scores of the various functional tests in the composite test will be evaluated to establish the key elements to be taken into account for subsequent management. These instructions will necessarily be personalized according to the scores.
干预措施: Personnalized physiotherapy (Other)
Usual physiotherapy
Following completion of the ankle go test, patients in "active comparator" group will undergo conventional rehabilitation following surgery.
干预措施: Usual physiotherapy (Other)
结局指标
主要结局
1-year post-surgery return to sport : Tegner questionnaire
时间窗: before surgery (anterior practice) and year 1
evaluation of sport practice level with Tegner questionnaire : Likert scale from 0 (professionnal disability) to 10 (professionnal sport)
次要结局
- Sports level at 1 year post-surgery compared with previous level(Year 1)
- Number of hours of sport per week(before surgery (anterior practice) and year 1)
- Pain: EVA analog scale(month 1, month 3, month 6, year 1)
- Ankle instability scale (FAAM questionnaire : Foot and Ankle Ability Measure)(before surgery (anterior practice) and month 3)