Chronic Ankle Instability, Surgical Repair: Open Versus Closed (CAISR)

Gwendolyn Vuurberg

Status: Completed

Conditions: Chronic Ankle Instability

Treatments: Procedure: Surgical stabilization

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02998333

NL55707.018.16 (Registry Identifier)

2016_136#B2016709

Details and patient eligibility

About

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).

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 2 patient groups

Open surgical ankle stabilization

Active Comparator group

Description:

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

Treatment:

Procedure: Surgical stabilization

Arthroscopic surgical ankle stabilization

Active Comparator group

Description:

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

Treatment:

Procedure: Surgical stabilization