Construction and Validation of a Score Evaluating the Residual Instability of the Patient After Ankle Ligamentoplasty

Ankle Sprains Clinical Trial

Official title:

Construction and Validation of a Score Evaluating the Residual Instability of the Patient After Ankle Ligamentoplasty - Ankle Go Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05331365
• Other study ID #: Ankle Go study
• Secondary ID: 2021-A03239-32
• Status: Completed
• Phase: N/A
• Start date: May 12, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2024
• Source: Elsan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains
• Sprains and Strains

Intervention

Other:
• Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical tests
Four tests and two questionnaires, each evaluating specific physical or psychological dimensions will be used to construct the composite score "Ankle Go Test" composite score: Foot and Ankle Ability Measure Questionnaire (FAAM) Ankle ligament reconstruction-return to sport after injury Questionnaire(ALR-RSI) Single Leg Stance Test (SLST) Side Hop Test (SHT) Star Excursion Balance Test (SEBT) Figure-of-8

Locations

Country	Name	City	State
France	Santé Atlantique	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Elsan

Country where clinical trial is conducted

France, 

References & Publications (12)

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. S — View 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. — View 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. — View 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. — View 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 — View 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 control — View 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 Surg — View 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 Traumat — View 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/ — View 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. — View 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. — View 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 a — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Three steps will be required to construct the "Ankle Go Test": Determining how much information the tests and questionnaires will contribute to the overall composite score (step 1); Construction of the score itself and extraction of a residual instability cut-off by the patient at 6 months post-intervention (step 2).; Confirmation of the weighting and validation of the composite score and the cut-off using an external population (external validation; step 3)	At 6 months post-intervention
Secondary	The composite score's sensibility to change (ability of the composite score to measure patients' progress)	The ability of the composite score to measure patients' progress will be measured by analysis of composite score results at 4 months, 6 months and 1 year post surgery	At 4 months, 6 months and 1 year post-intervention
Secondary	Reproductibility of the composite score	The reproductibility of the composite score will be measured by Analysis of composite score results at 24 hours interval.	At 6 months with interval of + 24 hours
Secondary	Discriminating ability of the composite score	Discriminating ability of the composite score will be measured by the Comparison of the composite score's results in post-operative patients to composite score's results in healthy volunteers	At 6 months post-intervention