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

Chronic Ankle Instability Clinical Trial

— ALSACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06228378
• Other study ID #: 2022-A01300-43
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Alexandre HARDY, MD
• Phone: 01 86 86 75 05
• Email: alexandre.hardy[@]me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Ankle Instability

Intervention

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).

Locations

Country	Name	City	State
France	Clinique du Sport	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Functional criterion (American Orthopaedic Foot and Ankle Society-AOFAS score)	Functional criterion (AOFAS score)	Month 6
Secondary	Tribological criteria (drop surface measurement)	Tribological criteria (drop surface measurement)	Month 6
Secondary	Tribological criteria (drop thickness measurement)	Tribological criteria (drop thickness measurement)	Month 6