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

  • End date
    Aug 14, 2023
  • participants needed
  • sponsor
    Gwendolyn Vuurberg
Updated on 25 February 2022


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 Brstrom procedure) is the current golden standard for surgical treatment of chronic ankle instability. The Brstrom 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).

Condition Chronic Ankle Instability
Treatment Surgical stabilization
Clinical Study IdentifierNCT02998333
SponsorGwendolyn Vuurberg
Last Modified on25 February 2022


Yes No Not Sure

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
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