Does Arthroscopic Anatomic Repair of the Anterior Talofibular Ligament Provide Better Functional Outcome Compared to Open Anatomic Repair in Patients With Chronic Ankle Instability: a Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Functional outcome
研究概览
简要总结
Rationale: Lateral ankle ligament injuries may be a result of ankle sprains. In 10-30% of patients with lateral ankle ligament injuries, chronic lateral ankle instability may be present. If conservative treatment fails, instability is treated surgically. Anatomic repair (also known as the Bröstrom procedure) is the current golden standard for surgical treatment of chronic ankle instability. The Bröstrom started out as an open technique and is now also performed arthroscopically. Both approaches are considered standard care and provide good results. Which approach is best, has not yet been researched. In this study it is hypothesized arthroscopic repair provides better functional outcome compared to open repair during short term follow-up.
Objective: The main objective of this study is to compare the functional outcome after arthroscopic and open anatomic repair in patients with chronic lateral ankle instability, and secondly to assess ankle stability and ankle Range of Motion (ROM) after arthroscopic and open ligament repair.
Study design: A Non-Blinded Prospective Randomized Controlled Trial Study population: All patients willing to participate, from an age of 18 years old, with persisting ankle instability for at least 6 months, eligible for anatomic repair.
Intervention: Both groups of patients are surgically treated with anatomic repair of the anterior talofibular ligament (ATFL). One group is treated arthroscopically and the other by the open approach.
Main study parameters/endpoints: The primary outcome measure is functional outcome 6 months after surgery measured using the Foot and Ankle Outcome Score. The main study parameter is a difference of ≥10 2 points per FAOS subscale between both treatment groups (Minimal Important Change = 10 points; 2 per subscale).
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 (Participant, Outcomes Assessor)
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
- •Patients are 18 years or older;
- •Experience pain and/or a sensation of instability during sports and/or daily activity;
- •Isolated lateral ankle instability;
- •Planned for surgical repair of the ATFL;
- •At least one previous episode of an ankle inversion sprain;
- •Complaints for at least 6 months;
- •Failed previous conservative treatment.
排除标准
- •Serious concomitant injury (like arthrosis, ruled out using an AP and lateral x-ray according to standard protocol);
- •Foot or ankle fracture in past;
- •Previous foot or ankle surgery;
- •ROM restriction of >10 degrees;
- •Medial instability;
- •Severe misalignment;
- •Ankle/foot deformities (e.g. severe flat foot);
- •Systemic comorbidity leading to delayed recovery (e.g. Diabetes Mellitus, Rheumatoid Arthritis)
- •(general) Hyper laxity
- •Inability or unwillingness to provide consent
- •Present factors that may cause difficulty of follow-up
结局指标
主要结局
Functional outcome
时间窗: 6 months
The primary outcome measures is a difference in pain and disability between both treatment groups as measured a Functional Ankle Outcome Score (FAOS) score change of ≥2 points per subscale measured at 6 months follow-up.
次要结局
- Functional outcome Numeric Rating Scale (NRS) pain(3- and 6 months)
- Functional outcome FAOS(3- and 6 months)
- Functional outcome Cumberland Ankle Instability Tool (CAIT)(3- and 6 months)
- Anterior Drawer Test (ADT)(Pre-operative, instraoperative, 3- and 6 months postoperative)
- Range of Motion (ROM)(Pre-operative, instraoperative, 3- and 6 months postoperative)
研究者
Gwendolyn Vuurberg
PhD Candidate
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)