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

January 31, 2021 updated by: Gwendolyn Vuurberg

Does Arthroscopic Anatomic Repair of the Anterior Talofibular Ligament Provide Better Functional Outcome Compared to Open Anatomic Repair in Patients With Chronic Ankle Instability: a Multicentre Randomized Controlled Trial

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Procedure: Surgical stabilization
Surgical stabilization of the ankle joint, performed as an open or arthroscopic procedure.
ACTIVE_COMPARATOR: 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.
Procedure: Surgical stabilization
Surgical stabilization of the ankle joint, performed as an open or arthroscopic procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcome
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcome FAOS
Time Frame: 3- and 6 months
For assessment disablement
3- and 6 months
Functional outcome Numeric Rating Scale (NRS) pain
Time Frame: 3- and 6 months
For pain assessment
3- and 6 months
Functional outcome Cumberland Ankle Instability Tool (CAIT)
Time Frame: 3- and 6 months
For instability assessment
3- and 6 months
Anterior Drawer Test (ADT)
Time Frame: 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).
Pre-operative, instraoperative, 3- and 6 months postoperative
Range of Motion (ROM)
Time Frame: 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.
Pre-operative, instraoperative, 3- and 6 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gwendolyn Vuurberg

Collaborators

Zimmer Biomet
Albert Schweitzer Hospital
Centro Hospitalar do Porto
Amphia Hospital
Site Hôpital orthopédique

Investigators

  • Principal Investigator: G.M.M.J. Kerkhoffs, Professor, Department of Orthopaedic Surgery, AMC, Amsterdam, The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

August 1, 2023

Study Registration Dates

First Submitted

December 16, 2016

First Submitted That Met QC Criteria

December 19, 2016

First Posted (ESTIMATE)

December 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2021

Last Update Submitted That Met QC Criteria

January 31, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016_136#B2016709
  • NL55707.018.16 (REGISTRY: ABR-form (toetsingonline.nl))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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