Chronic Ankle Instability, Surgical Repair: Open Versus Closed

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2025-03-31

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).

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Detailed Description

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Conditions

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Chronic Ankle Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Open surgical ankle stabilization

These patients will receive open surgical stabilization of the ankle joint after failed conservative treatment with complaints for at least 6 months.

Group Type ACTIVE_COMPARATOR

Surgical stabilization

Intervention Type PROCEDURE

Surgical stabilization of the ankle joint, performed as an open or arthroscopic procedure.

Arthroscopic surgical ankle stabilization

These patients will receive arthroscopic surgical stabilization of the ankle joint after failed conservative treatment with complaints for at least 6 months.

Group Type ACTIVE_COMPARATOR

Surgical stabilization

Intervention Type PROCEDURE

Surgical stabilization of the ankle joint, performed as an open or arthroscopic procedure.

Interventions

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Surgical stabilization

Surgical stabilization of the ankle joint, performed as an open or arthroscopic procedure.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No