Chronic Ankle Instability, Surgical Repair: Open Versus Closed

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Chronic Ankle Instability

Intervention / Treatment
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* Procedure: Surgical stabilization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open surgical ankle stabilization<br>These patients will receive open surgical stabilization of the ankle joint after failed conservative treatment with complaints for at least 6 months. | Procedure: Surgical stabilization<br>* Surgical stabilization of the ankle joint, performed as an open or arthroscopic procedure.<br>|
| Active Comparator: Arthroscopic surgical ankle stabilization<br>These patients will receive arthroscopic surgical stabilization of the ankle joint after failed conservative treatment with complaints for at least 6 months. | Procedure: Surgical stabilization<br>* Surgical stabilization of the ankle joint, performed as an open or arthroscopic procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome FAOS | For assessment disablement | 3- and 6 months | 
| Functional outcome Numeric Rating Scale (NRS) pain | For pain assessment | 3- and 6 months | 
| Functional outcome Cumberland Ankle Instability Tool (CAIT) | For instability assessment | 3- and 6 months | 
| Anterior Drawer Test (ADT) | The anterior drawer test is registered per mm (range 0-15mm) displacement and according to the manual anterior drawer test (M-ATT) categories (grade 0-3). | Pre-operative, instraoperative, 3- and 6 months postoperative | 
| Range of Motion (ROM) | ROM is registered in degrees of dorsi- and plantarflexion and is measured using a goniometer. Assessment is performed pre-operatively, and at 3- and 6-months postoperatively. | Pre-operative, instraoperative, 3- and 6 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Instability, Ankle, Surgical stabilization