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

Not Applicable

Completed

• Conditions: Chronic Ankle Instability
• Interventions: Other: Raman microspectroscopy

• Registration Number: NCT06228378
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

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.

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 Timeline

• Study Start: 2023-09-26
• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2024-01-26
• Study First Posted: 2024-01-29
• Primary Completion: 2025-01-28
• Study Completion: 2025-01-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unstable ankle	Raman microspectroscopy	Unstable ankle
Stable ankle	Raman microspectroscopy	-

Primary Outcome Measures

Name	Time	Method
Spectral intensity of synovial fluid components	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 Outcome Measures

Name	Time	Method
Functional criterion (American Orthopaedic Foot and Ankle Society-AOFAS score)	Month 6	Functional criterion (AOFAS score)
Tribological criteria (drop surface measurement)	Month 6	Tribological criteria (drop surface measurement)
Tribological criteria (drop thickness measurement)	Month 6	Tribological criteria (drop thickness measurement)

Trial Locations

Locations (1)

Clinique du Sport; 🇫🇷 Paris, France