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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Ankle Instability
• Intervention / Treatment: Other: Raman microspectroscopy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75005
    • Clinique du Sport

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unstable ankle	Other: Raman microspectroscopy; 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).
Active Comparator: Stable ankle	Other: Raman microspectroscopy; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spectral intensity of synovial fluid components	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.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional criterion (American Orthopaedic Foot and Ankle Society-AOFAS score)	Functional criterion (AOFAS score)	Month 6
Tribological criteria (drop surface measurement)	Tribological criteria (drop surface measurement)	Month 6
Tribological criteria (drop thickness measurement)	Tribological criteria (drop thickness measurement)	Month 6

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Investigators: Principal Investigator: Alexandre Hardy, MD, Clinique du Sport

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2023
• Primary Completion (Actual): January 28, 2025
• Study Completion (Actual): January 28, 2025

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2022-A01300-43

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No