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

Sponsor
Elsan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05331365
Collaborator
(none)
130
Enrollment
1
Location
3
Arms
27.7
Anticipated Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ankle injuries are the 2nd most common reason for admission to trauma emergency rooms. It is estimated that the number of sprains occurring per day in France. These injuries are mainly caused by by sports activities. Chronic instability is the most frequent complication that can occur in up to 40% of cases up to 40% of cases. In case of failure of conservative treatment for a minimum of 6 months, surgical management is surgical management is indicated to limit the risk of tibiotalar osteoarthritis, which increases with each episode of instability instability episode.

The main hypothesis of this study is that the Ankle Go Test composite score would to validate in a global way all the criteria of scores of 4 tests and 2 questionnaires, carried out in current practice.

Condition or Disease Intervention/Treatment Phase
  • Other: Evaluation of a specific physical or psychological dimensions
 N/A

Detailed Description

Ankle injuries are the 2nd most common reason for admission to trauma emergency rooms. It is estimated that the number of sprains occurring per day in France. These injuries are mainly caused by by sports activities. Chronic instability is the most frequent complication that can occur in up to 40% of cases up to 40% of cases. In case of failure of conservative treatment for a minimum of 6 months, surgical management is surgical management is indicated to limit the risk of tibiotalar osteoarthritis, which increases with each episode of instability instability episode.

Resumption of sport is one of the main issues following this type of surgery. Various scores to assess return to sport have been to evaluate the return to sport have already been created, notably after shoulder stabilization surgery or after anterior cruciate ligament reconstruction. Thus, the S-STARTS Test and the KSTARTS Test, each composed of 8 scores, are now considered objective measures in the evaluation of evaluation of the return to sport for the pathologies concerned. Residual instability after a ligament procedure and the resulting apprehension are the main obstacles to resuming sports activities.

For ankle surgery, there are clinical evaluation criteria reported in the literature as associated with chronic instability, but these have not been evaluated postoperatively and are of varying validity. disparate validity. However, a postoperative psychological assessment score has recently been evaluated.

This study will allow the creation of a composite score, entitled "Ankle Go Test". The study population was composed of patients who had undergone arthroscopic ankle ligamentoplasty. A group of control group, composed of patients who have not undergone ankle surgery, will also be part of the study to evaluate the discriminant validity of the Ankle Go Test score.

The main hypothesis of this study is that the Ankle Go Test composite score would to validate in a global way all the criteria of scores of 4 tests and 2 questionnaires, carried out in current practice, and The main hypothesis of this study is based on the fact that the composite score of 4 tests and 2 questionnaires, carried out in current practice, evaluating the instability of the ankle after ligamentoplasty on this one.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Patients who have undergone ankle ligamentoplasty will be seen by their surgeon 3 months after surgery as part of the standard by their surgeon 3 months after the operation, as part of the standard management. The study will be proposed to them and a consent form will be given to them. If the patients agree to take part in the study, they will sign the form at their next visit at 4 months. This consultation will correspond to the inclusion visit and the questionnaires and tests, allowing to build the score, will be the score will be carried out. Healthy volunteers will be selected on a voluntary basis at the request of the investigators for patients undergoing rehabilitation by physiotherapists at the investigation sites for upper limb problems and without upper limbs and with no history of knee or ankle problems.Patients who have undergone ankle ligamentoplasty will be seen by their surgeon 3 months after surgery as part of the standard by their surgeon 3 months after the operation, as part of the standard management. The study will be proposed to them and a consent form will be given to them. If the patients agree to take part in the study, they will sign the form at their next visit at 4 months. This consultation will correspond to the inclusion visit and the questionnaires and tests, allowing to build the score, will be the score will be carried out. Healthy volunteers will be selected on a voluntary basis at the request of the investigators for patients undergoing rehabilitation by physiotherapists at the investigation sites for upper limb problems and without upper limbs and with no history of knee or ankle problems.
Masking:
None (Open Label)
Masking Description:
Non-Health Product, multicenter, prospective, open-label, non-randomized study.
Primary Purpose:
Treatment
Official Title:
Construction and Validation of a Score Evaluating the Residual Instability of the Patient After Ankle Ligamentoplasty - Ankle Go Study
Actual Study Start Date :
May 12, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: The construction of the composite score and internal validations

50 patients for the construction of the composite score and internal validations. These tests and questionnaires are part of the standard post-operative management of a patient undergoing ankle ligamentoplasty. For the study, these tests and questionnaires will be performed.

Other: Evaluation of a specific physical or psychological dimensions
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.
Experimental: The external validation stage of the composite score

50 additional patients for the external validation stage of the composite score. These tests and questionnaires are part of the standard post-operative management of a patient undergoing ankle ligamentoplasty. For the study, these tests and questionnaires will be performed.

Other: Evaluation of a specific physical or psychological dimensions
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.
No Intervention: To analyze the ability of composite score discrimination

30 healthy volunteers will be included in the study to analyze the ability of composite score discrimination. The healthy population will perform the same physical and psychological tests as the population of the group, without having undergone ankle ligamentoplasty and without a history of ankle trauma ankle.

Outcome Measures

Primary Outcome Measures

  1. The construction of the " Ankle Go Test ", composed of the scores obtained from 4 tests and 2 questionnaires. [At 6 months post-intervention]

    The construction of the " Ankle Go Test ", composed of the scores obtained from 4 tests and 2 questionnaires conducted at 6 months post-intervention.

Secondary Outcome Measures

  1. Sensitivity to change of the composite score [At 4 months, 6 months and 1 year post-intervention]

    Sensitivity to change of the composite score (ability of the composite score to measure patient progress): Analysis of composite score results at 4 months, 6 months and 1 year.

  2. Reproducibility of the composite score: Analysis of composite score results [At 6 months with interval of + 24 hours]

    Reproducibility of the composite score: Analysis of composite score results at 24 hours interval.

  3. Discriminating ability of the score composite score [At 6 months post-intervention]

    Discriminating ability of the score composite score: Comparison of the results of the composite score between surgical patients and healthy volunteers

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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. Patient having been informed of the study and not having objected to it

Exclusion Criteria:

  1. Patients with chronic ankle instability, operated or not, contralateral

  2. Patients under legal protection

Contacts and Locations

Locations

Site City State Country Postal Code
1 Santé Atlantique Nantes France 44800

Sponsors and Collaborators

  • Elsan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elsan
ClinicalTrials.gov Identifier:
NCT05331365
Other Study ID Numbers:
  • Ankle Go study
  • 2021-A03239-32
First Posted:
Apr 15, 2022
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Ankle Injuries

Study Results

No Results Posted as of Aug 8, 2022