Does arthroscopic anatomic repair of the anterior talofibular ligament provide equal functional outcome compared to open anatomic repair in patients with chronic ankle instability: a multicentre randomized controlled trial.

Does arthroscopic anatomic repair of the anterior talofibular ligament provide equal functional outcome compared to open anatomic repair in patients with chronic ankle instability: a multicentre randomized controlled trial. - CAISR Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50173

Enrollment

Registered

2016-11-03

Start date

2017-02-23

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic ankle instability persisting ankle instability

Interventions

Both groups of patients are surgically treated by means of the Bröstrom-Gould technique. One group is treated by arthroscopic approach and the second group is treated by the open approach

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Serious concomitant injury - Acute foot or ankle fracture; - Previous foot or ankle surgery; - Osteochondral defect (OCD) of the talus with a diameter of >2cm treated using other techniques than bone marrow stimulation (BMS) - ROM restriction of >10 graden; - Medial instability - Severe misalignment; - Ankle/foot deformities - Systemic comorbidity leading to delayed recovery - (general) Hyperlaxity - Inability or unwillingness to provide consent - Present factors that may cause difficulty of follow-up

Design outcomes

Primary

Measure	Time frame
The main study parameter is a change in FAOS score of 10 points. This is measured using a questionnaire containing the foot and ankle outcome score (FAOS), numeratic rating scale (NRS) and Cumberland ankle instability tool (CAIT). The primary outcome measures are pain, disability and degree of experienced ankle instability, using. Assessment is performed pre-operatively, and at 3- and 6-months postoperatively.	—

Measure

Time frame

The main study parameter is a change in FAOS score of 10 points. This is measured using a questionnaire containing the foot and ankle outcome score (FAOS), numeratic rating scale (NRS) and Cumberland ankle instability tool (CAIT). The primary outcome measures are pain, disability and degree of experienced ankle instability, using. Assessment is performed pre-operatively, and at 3- and 6-months postoperatively.

—

Secondary

Measure	Time frame
Secondary study parameters are a negative anterior drawer test and normal ROM. The anterior drawer test is registered per mm (range 0-15mm) displacement. 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. Additionally we measure complications and recurrence of instability.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)