NCT04362488

Brief Summary

The objective of the study is to evaluate the postural control and proprioception before and after external capsulo-ligament reconstruction for ankle instability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2019

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2023

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

3 years

First QC Date

February 8, 2019

Last Update Submit

December 5, 2023

Conditions

Ankle SprainsInstability, Joint

Keywords

sprainBrostromankle instability

Outcome Measures

Primary Outcomes (6)

  • Delos (computerized oscillating platform)

    The patients will be analyzed pre and postoperatively using a computerized oscillating platform that shows the response of the foot as an adaptation to the ground. The result is expressed through stability index (%) compared to the average of the population.

    End of the study, 18 month from the beginning (04 August 2020)

  • Foot & Ankle Ability Measure (FAAM) questionnaire.

    FAAM: expresses the personal evaluation of the patient on his difficulty in performing activities using 5 values for each question: no difficulty, slight difficulty, moderate difficulty, extreme difficulty, inability.

    End of the study, 18 month from the beginning (04 August 2020)

  • American Orthopaedic Foot & Ankle score (AOFAs) questionnaire

    AOFAs: values from 0 to 100 dependent on limitations in performing activities

    End of the study, 18 month from the beginning (04 August 2020)

  • Short Form Health Survey - 12 questionnaire

    SF12: personal assessment of one's state of health using multiple-answer questions with different values for each question.

    End of the study, 18 month from the beginning (04 August 2020)

  • modified Star Excursional Balance Test (mSEBT) functional test

    mSEBT: best value resulting from the 3 equilibrium tests standardized for the length of the limb. The tests consist in reaching the greater distance with a foot along three (inverted Y-shaped) axes with between them an angle of 90 ° (rear) and two of 135 ° (antero-medial and anterior-lateral) while the opposite foot remains still on the ground

    End of the study, 18 month from the beginning (04 August 2020)

  • Short Physical Performance Battery functional test

    The SPPB scale is a short battery of tests designed to evaluate the functionality of the lower limbs. This battery consists of 3 different sections. The total score of the scale has a range from 0 to 12.

    End of the study, 18 month from the beginning (04 August 2020)

Study Arms (1)

Patients with chronic post-traumatic lateral ankle instability

EXPERIMENTAL

The study population consists in patients affected by chronic post-traumatic lateral ankle instability who must undergo surgical intervention of ankle external ligament reconstruction. The patients will be analyzed pre and postoperatively using differents tests, questionnaires, instrument and clinical evaluation: * Delos system (computerized oscillating platform) * Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires * modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB)

Procedure: Preoperative evaluationProcedure: Postoperative evaluation

Interventions

Preoperative evaluationPROCEDURE

Preoperative evaluation using differents clinical evaluation tests, questionnaires, and instrument: * Delos system (computerized oscillating platform) * Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires * modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB)

Also known as: Questionnaires: "FAAM", "AOFAs", "SF12", Instrument: "Delos computerized oscillating platform", Tests: "mSEBT", "SPPB"
Patients with chronic post-traumatic lateral ankle instability
Postoperative evaluationPROCEDURE

Postoperative evaluation at 4 months of follow up after surgery using differents clinical evaluation tests, questionnaires, and instrument: * Delos system (computerized oscillating platform) * Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires * modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB)

Also known as: Questionnaires: "FAAM", "AOFAs", "SF12", Instrument: "Delos computerized oscillating platform", Tests: "mSEBT", "SPPB"
Patients with chronic post-traumatic lateral ankle instability

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients who must undergo surgery;
  • patients of both sexes aged between 18-40 years;
  • patients who have given their informed written consent to participate in the study;
  • patients who have given their consent to reach the Hospital to perform the 4-month check-up

You may not qualify if:

  • patients with BMI\> 30 kg / m2;
  • patients with rheumatoid arthritis;
  • patients with chronic inflammatory joint diseases;
  • patients with pre-existing abnormalities of the ambulatory kinematics (amputations, neuro-muscular diseases, polio, hip dysplasias);
  • patients with Severe arthrosis of the ankle (Kellgren-Lawrence\> 3);
  • patients with Severe knee arthritis (Kellgren-Lawrence\> 3);
  • patients with ACL injury;
  • patients with severe postural instability;
  • patients with cognitive impairments;
  • patients with concomitant neurological diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rizzoli Orthopaedic Institute

Bologna, BO, 40126, Italy

Location

MeSH Terms

Conditions

Ankle InjuriesJoint InstabilitySprains and Strains

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Massimiliano Mosca

    Rizzoli Orthopaedic Istitute, Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: All patients who undergo surgery for a ankle lateral ligament reconstruction from 4th Febbruary 2019 till to the end of the study on 4th August 2020
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2019

First Posted

April 27, 2020

Study Start

February 4, 2019

Primary Completion

February 1, 2022

Study Completion

November 11, 2023

Last Updated

December 6, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)