Chronic Ankle Instability, Surgical Repair: Open Versus Closed

Not Applicable

• Conditions: Chronic Ankle Instability
• Interventions: Procedure: Surgical stabilization

• Registration Number: NCT02998333
• Lead Sponsor: Gwendolyn Vuurberg

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-16
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-20
• Study Start: 2017-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-31
• Last Update Posted: 2021-02-03
• Primary Completion: 2023-01
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arthroscopic surgical ankle stabilization	Surgical stabilization	These patients will receive arthroscopic surgical stabilization of the ankle joint after failed conservative treatment with complaints for at least 6 months.
Open surgical ankle stabilization	Surgical stabilization	These patients will receive open surgical stabilization of the ankle joint after failed conservative treatment with complaints for at least 6 months.

Primary Outcome Measures

Name	Time	Method
Functional outcome	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.

Secondary Outcome Measures

Name	Time	Method
Functional outcome FAOS	3- and 6 months	For assessment disablement
Functional outcome Numeric Rating Scale (NRS) pain	3- and 6 months	For pain assessment
Functional outcome Cumberland Ankle Instability Tool (CAIT)	3- and 6 months	For instability assessment
Anterior Drawer Test (ADT)	Pre-operative, instraoperative, 3- and 6 months postoperative	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).
Range of Motion (ROM)	Pre-operative, instraoperative, 3- and 6 months postoperative	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.

Trial Locations

Locations (3)

Centro Hospitalar Povoa deVarzim; 🇵🇹 Porto, Portugal

AMC; 🇳🇱 Amsterdam, Netherlands

Site Hôpital orthopédique; 🇨🇭 Lausanne, Switzerland