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

NCT06228378 | Completed

• 1 other identifier: 2022-A01300-43
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Ankle Instability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Month 6

• Tribological criteria (drop surface measurement)

  Month 6

• Tribological criteria (drop thickness measurement)

  Month 6

Study Arms (2)

Unstable ankle

EXPERIMENTAL

Unstable ankle

Other: Raman microspectroscopy

Stable ankle

ACTIVE COMPARATOR

Other: Raman microspectroscopy

Interventions

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).

Stable ankle; Unstable ankle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique du Sport

Paris, 75005, France

Location

Study Officials

• Alexandre HARDY, MD

  Clinique du sport

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-centre, open-label study of patients undergoing ankle stabilisation surgery.

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 29, 2024
• Study Start: September 26, 2023
• Primary Completion: January 28, 2025
• Study Completion: January 28, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

FR (1)