Chronic Ankle Instability
Conditions
Keywords
Instability, Ankle, Surgical stabilization
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).
Interventions
PROCEDURESurgical stabilization
Surgical stabilization of the ankle joint, performed as an open or arthroscopic procedure.
Sponsors
Zimmer Biomet
Centro Hospitalar do Porto
Site Hôpital orthopédique
Amphia Hospital
Albert Schweitzer Hospital
Gwendolyn Vuurberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Netherlands, Portugal, Switzerland
Outcome results
None listed