Skip to main content
OpenTrials
Completed

NCT Number: NCT06228378

Comparative Spectroscopic Analysis of Synovial Fluid From the Stable and Unstable Ankle

A population of patients with chronic ankle instability for whom arthroscopic ligament stabilisation was indicated.

Main objective: to use the Raman microspectroscopy technique to characterise the synovial fluid of the unstable ankle in comparison with the synovial fluid of the healthy ankle.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Ankle Instability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique du Sport

Paris, 75005, France

About this study

Single-centre, prospective, open-label study of patients undergoing ankle stabilisation surgery.

Patients will participate in the study for six months. Three arthrocentheses with synovial fluid sampling will be performed Two at D0: on the healthy ankle and the pathological ankle One at M6: on the operated ankle A follow-up visit will take place 10 days after the arthrocentesis performed at D0 and after the one performed at M6. The purpose of these visits, which are carried out systematically by the centre's doctors as part of the surgical procedures, is to check that there are no complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 or over who have signed their consent to participate in the study
  • Patients with chronic unilateral lateral ankle instability
  • Patients who have not responded to medical treatment and for whom arthroscopic stabilisation of the ankle is planned.

Exclusion criteria

  • Any history, anomaly or symptom relating to the contralateral ankle
  • Patient under court protection, guardianship or curatorship

Treatment and study plan

Raman microspectroscopy

Other

Raman microspectroscopy is a non-destructive method for observing and characterising the molecular composition and external structure of a biological sample based on the phenomenon of inelastic light scattering (Raman effect).

Primary outcomes

  1. Spectral intensity of synovial fluid components

    Time frame: Month 6

    Spectral intensity of synovial fluid components :

    Raman microspectroscopy is a non-destructive method for observing and characterising the molecular composition and external structure of a biological sample based on the phenomenon of inelastic light scattering.

    Four regions of interest (ROIs) are defined at the four cardinal points in the peripheral zone where the pre-concentration of solutes is maximal. Six points are mapped in each ROI. Each drop is thus defined by 4 x 6 points, making it possible to check intra- and inter-ROI homogeneity. Spectral acquisitions were carried out after illumination by a laser source.

    The mean spectrum of each LS drop is defined as the average of the four mean spectra of the ROIs, originating from the four cardinal points of the drop. The component Raman bands are identified and assigned on the basis of bibliographic data.

Secondary outcomes

  1. Functional criterion (American Orthopaedic Foot and Ankle Society-AOFAS score)

    Time frame: Month 6

    Functional criterion (AOFAS score)

  2. Tribological criteria (drop surface measurement)

    Time frame: Month 6

    Tribological criteria (drop surface measurement)

  3. Tribological criteria (drop thickness measurement)

    Time frame: Month 6

    Tribological criteria (drop thickness measurement)

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: ALSACE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2024
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.