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CompletedNCT06228378ALSACEUpdated Apr 6, 2025

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

An interventional study of Raman microspectroscopy in Chronic Ankle Instability, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-06.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Ankle Instability
03

In context

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 198 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Any history, anomaly or symptom relating to the contralateral ankle
  • Patient under court protection, guardianship or curatorship
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Unstable ankle

    Unstable ankle

    Other: Raman microspectroscopy

  • Active comparator
    Stable ankle

    Other: Raman microspectroscopy

Interventions

  • OtherRaman 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).

06

What researchers measure

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.

    Time frame: Month 6

Secondary outcomes

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

    Functional criterion (AOFAS score)

    Time frame: Month 6

  2. Tribological criteria (drop surface measurement)

    Tribological criteria (drop surface measurement)

    Time frame: Month 6

  3. Tribological criteria (drop thickness measurement)

    Tribological criteria (drop thickness measurement)

    Time frame: Month 6

07

Study locations

1 site
  • Clinique du Sport
    Paris, 75005, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06228378
Lead sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Responsible party
Sponsor
First posted
Jan 29, 2024
Start date
Sep 26, 2023
Primary completion
Jan 28, 2025
Completion
Jan 28, 2025
Last update
Apr 6, 2025

Study contacts

Alexandre HARDY, MD
principal investigator · Clinique du sport

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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