Chronic Ankle Instability, Surgical Repair: Open Versus Closed

NCT02998333 | Completed

• 2 other identifiers: 2016_136#B2016709NL55707.018.16
• Study Type: interventional
• Target: 41
• Locations: 3 countries
• Sites: 3

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).

Conditions

Chronic Ankle Instability

Keywords

Instability; Ankle; Surgical stabilization

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (5)

• Functional outcome FAOS

  3- and 6 months

• Functional outcome Numeric Rating Scale (NRS) pain

  3- and 6 months

• Functional outcome Cumberland Ankle Instability Tool (CAIT)

  3- and 6 months

• Anterior Drawer Test (ADT)

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

• Range of Motion (ROM)

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

Study Arms (2)

Open surgical ankle stabilization

ACTIVE COMPARATOR

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

Arthroscopic surgical ankle stabilization

ACTIVE COMPARATOR

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

Interventions

Surgical stabilization PROCEDURE

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

Arthroscopic surgical ankle stabilization; Open surgical ankle stabilization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gwendolyn Vuurberg: lead
• Zimmer Biomet: collaborator
• Centro Hospitalar do Porto: collaborator
• Site Hôpital orthopédique: collaborator
• Amphia Hospital: collaborator
• Albert Schweitzer Hospital: collaborator

Study Sites (3)

AMC

Amsterdam, 1105 AZ, Netherlands

Location

Centro Hospitalar Povoa deVarzim

Porto, Portugal

Location

Site Hôpital orthopédique

Lausanne, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 24962695 BACKGROUND

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

  PMID: 5339635 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 27073785 BACKGROUND

• 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.

  PMID: 24850160 BACKGROUND

• 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.

  PMID: 26467354 BACKGROUND

Study Officials

• G.M.M.J. Kerkhoffs, Professor

  Department of Orthopaedic Surgery, AMC, Amsterdam, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 20, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1); NL (1); CH (1)