Comparative Spectroscopic Analysis of Synovial Fluid From the Stable and Unstable Ankle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Spectral intensity of synovial fluid components
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Any history, anomaly or symptom relating to the contralateral ankle
- •Patient under court protection, guardianship or curatorship
研究组 & 干预措施
Unstable ankle
Unstable ankle
干预措施: Raman microspectroscopy (Other)
Stable ankle
干预措施: Raman microspectroscopy (Other)
结局指标
主要结局
Spectral intensity of synovial fluid components
时间窗: 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.
次要结局
- 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)