Clinical trial NCT05331365: Construction and Validation of a Score Evaluating the Residual Instability of the Patient After Ankle Ligamentoplasty
Official title: Construction and Validation of a Score Evaluating the Residual Instability of the Patient After Ankle Ligamentoplasty - Ankle Go Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Sprains
Ligament Sprain
Keywords: ligamentoplasty
chronic ankle instability
score
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who have undergone ankle ligamentoplasty 4 months ago will be included in the study.

Healthy volunteers will be selected on a voluntary basis at the request of the investigators in the population of patients undergoing rehabilitation by physiotherapists at the investigation sites and with no history of knee or ankle problems.
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this prospective, open label study is the construction and the evaluation of a composite score evaluating the residual instability in patients who have undergone an ankle's ligamentoplasty (the Ankle Go Test score).

The main hypothesis of this study is based on the fact that the composite score "Ankle Go Test" would allow a global validation of all the criteria of scores of 4 tests and 2 questionnaires, which are performed in common pratice, evaluating the instability of the ankle after an ankle ligamentoplasty.

Participants will have to complete 2 questionnaires (FAAM, ALR RS) and to undergoe 4 tests (Single Leg Stance Test, Side Hop Test, Start Excursion Balance Test, La figure of 8), at 4, 6 and 12 months post surgery.

Researchers will compare the group of participants who undergone ankle's ligamentoplasty with a group of healthy volunteers to assess the discriminant validity of the Ankle Go Test score


Eligibility criteria: Inclusion Criteria:

1. Male and female patients who underwent arthroscopic ankle ligamentoplasty or healthy volunteers with no previous knee or ankle history.
2. Age ≥ 18 years
3. Patients who's been informed about the study and who didn't express their opposition to participate

Exclusion Criteria:

1. Patients with chronic ankle instability, operated or not, contralateral
2. Patients under legal protection

Primary outcomes:
measure: The construction of the " Ankle Go Test ", composed of the scores obtained from the 4 tests and 2 questionnaires perfomed 6 months post ankle's surgery
timeFrame: At 6 months post-intervention
Secondary outcomes:
measure: The composite score's sensibility to change (ability of the composite score to measure patients' progress)
timeFrame: At 4 months, 6 months and 1 year post-intervention
measure: Reproductibility of the composite score
timeFrame: At 6 months with interval of + 24 hours
measure: Discriminating ability of the composite score
timeFrame: At 6 months post-intervention
Other outcomes:
Locations:
city: Nantes
country: France
facility: Santé Atlantique
Study officials:
References:
citation: Lopes R, Andrieu M, Cordier G, Molinier F, Benoist J, Colin F, Thes A, Elkaim M, Boniface O, Guillo S, Bauer T; French Arthroscopic Society. Arthroscopic treatment of chronic ankle instability: Prospective study of outcomes in 286 patients. Orthop Traumatol Surg Res. 2018 Dec;104(8S):S199-S205. doi: 10.1016/j.otsr.2018.09.005. Epub 2018 Sep 21.
citation: Lopes R, Noailles T, Brulefert K, Geffroy L, Decante C. Anatomic validation of the lateral malleolus as a cutaneous marker for the distal insertion of the calcaneofibular ligament. Knee Surg Sports Traumatol Arthrosc. 2018 Mar;26(3):869-874. doi: 10.1007/s00167-016-4250-7. Epub 2016 Aug 6.
citation: Jure D, Blache Y, Degot M, Vigne G, Nove-Josserand L, Godeneche A, Collotte P, Franger G, Borel F, Rogowski I, Neyton L. The S-STARTS Test: Validation of a Composite Test for the Assessment of Readiness to Return to Sport After Shoulder Stabilization Surgery. Sports Health. 2022 Mar-Apr;14(2):254-261. doi: 10.1177/19417381211004107. Epub 2021 Apr 9.
citation: Blakeney WG, Ouanezar H, Rogowski I, Vigne G, Guen ML, Fayard JM, Thaunat M, Chambat P, Sonnery-Cottet B. Validation of a Composite Test for Assessment of Readiness for Return to Sports After Anterior Cruciate Ligament Reconstruction: The K-STARTS Test. Sports Health. 2018 Nov/Dec;10(6):515-522. doi: 10.1177/1941738118786454. Epub 2018 Jul 19.
citation: Carcia CR, Martin RL, Drouin JM. Validity of the Foot and Ankle Ability Measure in athletes with chronic ankle instability. J Athl Train. 2008 Apr-Jun;43(2):179-83. doi: 10.4085/1062-6050-43.2.179.
citation: Borloz S, Crevoisier X, Deriaz O, Ballabeni P, Martin RL, Luthi F. Evidence for validity and reliability of a French version of the FAAM. BMC Musculoskelet Disord. 2011 Feb 8;12:40. doi: 10.1186/1471-2474-12-40.
citation: Docherty CL, Arnold BL, Gansneder BM, Hurwitz S, Gieck J. Functional-Performance Deficits in Volunteers With Functional Ankle Instability. J Athl Train. 2005 Mar;40(1):30-34.
citation: Franck F, Saithna A, Vieira TD, Pioger C, Vigne G, Le Guen M, Rogowski I, Fayard JM, Thaunat M, Sonnery-Cottet B. Return to Sport Composite Test After Anterior Cruciate Ligament Reconstruction (K-STARTS): Factors Affecting Return to Sport Test Score in a Retrospective Analysis of 676 Patients. Sports Health. 2021 Jul-Aug;13(4):364-372. doi: 10.1177/1941738120978240. Epub 2021 Feb 6.
citation: Gribble PA, Delahunt E, Bleakley C, Caulfield B, Docherty CL, Fourchet F, Fong D, Hertel J, Hiller C, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino B, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Orthop Sports Phys Ther. 2013 Aug;43(8):585-91. doi: 10.2519/jospt.2013.0303. Epub 2013 Jul 31.
citation: Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM. Evidence of validity for the Foot and Ankle Ability Measure (FAAM). Foot Ankle Int. 2005 Nov;26(11):968-83. doi: 10.1177/107110070502601113.
citation: Rosen AB, Needle AR, Ko J. Ability of Functional Performance Tests to Identify Individuals With Chronic Ankle Instability: A Systematic Review With Meta-Analysis. Clin J Sport Med. 2019 Nov;29(6):509-522. doi: 10.1097/JSM.0000000000000535.
citation: Sigonney F, Lopes R, Bouche PA, Kierszbaum E, Moslemi A, Anract P, Stein A, Hardy A. The ankle ligament reconstruction-return to sport after injury (ALR-RSI) is a valid and reproducible scale to quantify psychological readiness before returning to sport after ankle ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2020 Dec;28(12):4003-4010. doi: 10.1007/s00167-020-06020-6. Epub 2020 Apr 30.