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

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Enrolling

Conditions: Chronic Ankle Instability

Treatments: Other: Raman microspectroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06228378

2022-A01300-43

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Unstable ankle

Experimental group

Description:

Unstable ankle

Treatment:

Other: Raman microspectroscopy

Stable ankle

Active Comparator group

Treatment:

Other: Raman microspectroscopy