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Chronic Ankle InstabilityCAISRNCT02998333

Chronic Ankle Instability, Surgical Repair: Open Versus Closed

A study testing Surgical stabilization in people with Chronic Ankle Instability, run by Gwendolyn Vuurberg at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Ankle Instability
What is being tested?
Surgical stabilization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
3 sitesin 3 countries
Study dates
Jan 2017to Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 11Show fewer
  • 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 locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Netherlands1 site

  • AMC

    Amsterdam, 1105 AZ

Other trials in Netherlands

Portugal1 site

  • Centro Hospitalar Povoa deVarzim

    Porto

Other trials in Portugal

Switzerland1 site

  • Site Hôpital orthopédique

    Lausanne

Other trials in Switzerland

About this study

Official title: 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.

Read more

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).

Being tested
Surgical stabilization
Keywords
Instability, Ankle, Surgical stabilization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgical stabilizationProcedure or surgery

    Surgical stabilization of the ankle joint, performed as an open or arthroscopic procedure.

Study groups in NCT02998333
Study groupRoleWhat they receive
Open surgical ankle stabilizationActive comparatorThese patients will receive open surgical stabilization of the ankle joint after failed conservative treatment with complaints for at least 6 months.
Receives: Procedure: Surgical stabilization
Arthroscopic surgical ankle stabilizationActive comparatorThese patients will receive arthroscopic surgical stabilization of the ankle joint after failed conservative treatment with complaints for at least 6 months.
Receives: Procedure: Surgical stabilization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional outcome

    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.

    Measured: 6 months

Secondary outcomes (5)

  1. Functional outcome FAOS

    For assessment disablement

    Measured: 3- and 6 months

  2. Functional outcome Numeric Rating Scale (NRS) pain

    For pain assessment

    Measured: 3- and 6 months

  3. Functional outcome Cumberland Ankle Instability Tool (CAIT)

    For instability assessment

    Measured: 3- and 6 months

  4. Anterior Drawer Test (ADT)

    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).

    Measured: Pre-operative, instraoperative, 3- and 6 months postoperative

  5. Range of Motion (ROM)

    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.

    Measured: Pre-operative, instraoperative, 3- and 6 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionJan 2025
  4. Study completionMar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02998333
Sponsor's protocol ID
2016_136#B2016709
Other IDs
NL55707.018.16
Acronym
CAISR
Status last verified
Oct 2025
First submitted
16 Dec 2016
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kobayashi T, Gamada K. Lateral Ankle Sprain and Chronic Ankle Instability: A Critical Review. Foot Ankle Spec. 2014 Aug 1;7(4):298-326. doi: 10.1177/1938640014539813. Epub 2014 Jun 24.

    PubMed 24962695

  • Brostrom L. Sprained ankles. VI. Surgical treatment of "chronic" ligament ruptures. Acta Chir Scand. 1966 Nov;132(5):551-65. No abstract available.

    PubMed 5339635

  • Mabit, C.C., J.M.; Fiorenza, F.; Huc, H.; Pecout, C., Lateral ligament reconstruction of the ankle: comparative study of peroneus brevis tenodesis versus periosteal ligamentoplasty. Foot and Ankle Surgery, 1998. 4(2): p. 6.

  • Pereira H, Vuurberg G, Gomes N, Oliveira JM, Ripoll PL, Reis RL, Espregueira-Mendes J, Niek van Dijk C. Arthroscopic Repair of Ankle Instability With All-Soft Knotless Anchors. Arthrosc Tech. 2016 Feb 1;5(1):e99-e107. doi: 10.1016/j.eats.2015.10.010. eCollection 2016 Feb.

    PubMed 27073785

  • Drakos MC, Behrens SB, Paller D, Murphy C, DiGiovanni CW. Biomechanical Comparison of an Open vs Arthroscopic Approach for Lateral Ankle Instability. Foot Ankle Int. 2014 Aug;35(8):809-815. doi: 10.1177/1071100714535765. Epub 2014 May 21.

    PubMed 24850160

  • Matsui K, Takao M, Miyamoto W, Matsushita T. Early recovery after arthroscopic repair compared to open repair of the anterior talofibular ligament for lateral instability of the ankle. Arch Orthop Trauma Surg. 2016 Jan;136(1):93-100. doi: 10.1007/s00402-015-2342-3. Epub 2015 Oct 14.

    PubMed 26467354

  • Vuurberg G, Maria PA, Baalbaki R, Haverkamp D, Sierevelt IN, Stufkens SAS, Pereira H, M M J Kerkhoffs G; CAISR Trial Study Group; Altink NA, van Bergen CJA, Blankevoort L, Crevoisier X, van Dijk CN, Hoornenborg D, Krips R, de Leeuw PA, Peerbooms JC, Reilingh ML, Sousa D, Stanekova K. No Difference Between Open and Arthroscopic ATFL Repair, Both Yielding Clinically Significant Improvement in Chronic Ankle Instability: A Randomized Controlled Trial. Orthop J Sports Med. 2026 Apr 8;14(4):23259671261417357. doi: 10.1177/23259671261417357. eCollection 2026 Apr.

    PubMed 41970204

Questions about this trial

What is this clinical trial studying?

A study testing Surgical stabilization in people with Chronic Ankle Instability, run by Gwendolyn Vuurberg at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands, Portugal, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional outcome (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02998333, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.

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