Clinical trial NCT02998333: Chronic Ankle Instability, Surgical Repair: Open Versus Closed
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Ankle Instability
Keywords: Instability
Ankle
Surgical stabilization
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
name: Centro Hospitalar do Porto
name: Site Hôpital orthopédique
name: Amphia Hospital
name: Albert Schweitzer Hospital
First posted: 2016-12-20
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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:

* 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

Primary outcomes:
measure: Functional outcome
timeFrame: 6 months
Secondary outcomes:
measure: Functional outcome FAOS
timeFrame: 3- and 6 months
measure: Functional outcome Numeric Rating Scale (NRS) pain
timeFrame: 3- and 6 months
measure: Functional outcome Cumberland Ankle Instability Tool (CAIT)
timeFrame: 3- and 6 months
measure: Anterior Drawer Test (ADT)
timeFrame: Pre-operative, instraoperative, 3- and 6 months postoperative
measure: Range of Motion (ROM)
timeFrame: Pre-operative, instraoperative, 3- and 6 months postoperative
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: AMC
city: Porto
country: Portugal
facility: Centro Hospitalar Povoa deVarzim
city: Lausanne
country: Switzerland
facility: Site Hôpital orthopédique
Study officials:
affiliation: Department of Orthopaedic Surgery, AMC, Amsterdam, The Netherlands
name: G.M.M.J. Kerkhoffs, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Brostrom L. Sprained ankles. VI. Surgical treatment of "chronic" ligament ruptures. Acta Chir Scand. 1966 Nov;132(5):551-65. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.