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

Primary Purpose

Ankle Sprains, Ligament Sprain

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical tests
Sponsored by
Elsan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ankle Sprains focused on measuring ligamentoplasty, chronic ankle instability, score

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Santé Atlantique

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Group of the construction of the composite Ankle go score and internal validations

group of the external validation stage of the composite score

Group allowing the assessment of the score's ability to discriminate

Arm Description

50 patients will be include for the construction of the composite score and its internal validations. They will complete questionnaires (FAAM, ALR-RSI) and undergo tests (SLSTS, SHTS, SEBT and Figure of 8) 4 months after ankle's surgery (visit 1), 6 months after surgery (visit 2) and 12 months post surgery

50 additional patients for the external validation stage of the composite score. They will complete questionnaires (FAAM, ALR-RSI) and undergo tests (SLSTS, SHTS, SEBT and Figure of 8) 4 months after ankle's surgery (visit 1) and 6 months after surgery (visit 2)

30 healthy volunteers (who did not undergone an ankle's surgery) will be included in the study to analyze the ability of composite score to discriminate. The healthy population will perform the same physical and psychological tests as Group allowing the construction of the composite Ankle go score and internal validations

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
Reproductibility of the composite score
The reproductibility of the composite score will be measured by Analysis of composite score results at 24 hours interval.
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

Full Information

First Posted
April 4, 2022
Last Updated
March 27, 2023
Sponsor
Elsan
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1. Study Identification

Unique Protocol Identification Number
NCT05331365
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elsan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains, Ligament Sprain
Keywords
ligamentoplasty, chronic ankle instability, score

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group of the construction of the composite Ankle go score and internal validations
Arm Type
Experimental
Arm Description
50 patients will be include for the construction of the composite score and its internal validations. They will complete questionnaires (FAAM, ALR-RSI) and undergo tests (SLSTS, SHTS, SEBT and Figure of 8) 4 months after ankle's surgery (visit 1), 6 months after surgery (visit 2) and 12 months post surgery
Arm Title
group of the external validation stage of the composite score
Arm Type
Experimental
Arm Description
50 additional patients for the external validation stage of the composite score. They will complete questionnaires (FAAM, ALR-RSI) and undergo tests (SLSTS, SHTS, SEBT and Figure of 8) 4 months after ankle's surgery (visit 1) and 6 months after surgery (visit 2)
Arm Title
Group allowing the assessment of the score's ability to discriminate
Arm Type
No Intervention
Arm Description
30 healthy volunteers (who did not undergone an ankle's surgery) will be included in the study to analyze the ability of composite score to discriminate. The healthy population will perform the same physical and psychological tests as Group allowing the construction of the composite Ankle go score and internal validations
Intervention Type
Other
Intervention Name(s)
Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical tests
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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)
Time Frame
At 6 months post-intervention
Secondary Outcome Measure Information:
Title
The composite score's sensibility to change (ability of the composite score to measure patients' progress)
Description
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
Time Frame
At 4 months, 6 months and 1 year post-intervention
Title
Reproductibility of the composite score
Description
The reproductibility of the composite score will be measured by Analysis of composite score results at 24 hours interval.
Time Frame
At 6 months with interval of + 24 hours
Title
Discriminating ability of the composite score
Description
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
Time Frame
At 6 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female patients who underwent arthroscopic ankle ligamentoplasty or healthy volunteers with no previous knee or ankle history. Age ≥ 18 years Patients who's been informed about the study and who didn't express their opposition to participate Exclusion Criteria: Patients with chronic ankle instability, operated or not, contralateral Patients under legal protection
Facility Information:
Facility Name
Santé Atlantique
City
Nantes
ZIP/Postal Code
44800
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30245066
Citation
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Results Reference
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PubMed Identifier
27497693
Citation
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PubMed Identifier
33834924
Citation
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Results Reference
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PubMed Identifier
30024344
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.
Results Reference
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PubMed Identifier
18345343
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.
Results Reference
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PubMed Identifier
21303520
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.
Results Reference
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PubMed Identifier
15902321
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.
Results Reference
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PubMed Identifier
33550916
Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Construction and Validation of a Score Evaluating the Residual Instability of the Patient After Ankle Ligamentoplasty

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