Sonographic Follow-up of Patients With Cubital Tunnel Syndrome (CTS) Undergoing Open Neurolysis in Situ or Endoscopic Release: A Prospective Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- American Shoulder and Elbow Society Function Score
研究概览
简要总结
The investigators want to compare changes in cross-sectional area (CSA) of the ulnar nerve at the elbow after open release or endoscopic release.
详细描述
The investigators want to compare changes in CSA of the ulnar nerve at the elbow hypothesizing that US examination is a useful tool to detect unsuccessful release and defining which technique shows the best outcome in the first year postoperatively.
The measurement of cross-sectional area (CSA) as a diagnostic tool to detect entrapments syndrome in upper limbs has already been described. US typically demonstrates an abrupt narrowing and displacement of the nerve within the tunnel, possibly in association with a thickened retinaculum or a space-occupying lesions. Previous studies prospectively compared sonographic outcomes after decompression of the median nerve at the wrist.
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
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •history of paresthesia or numbness in the ulnar nerve distribution;
- •weakness or wasting of the small muscles of the hand;
- •a positive elbow flexion provocation test;
- •slowed motor conduction velocity in the ulnar nerve below 50 m/sec.
排除标准
- •Patients with normal nerve conduction studies;
- •prior surgery for Cubital Tunnel Syndrome;
- •prior traumatic lesions of the elbow;
- •coexistent neurological diseases;
- •bone anormalities (cubitus valgus, deformities from previous elbow fractures, osteoarthritis with medial osteophytes ands loose bodies, heterotopic ossifications);
- •subluxating ulnar nerve;
- •space-occupying soft-tissue lesions.
结局指标
主要结局
American Shoulder and Elbow Society Function Score
时间窗: 12 months postoperatively.
Patients undergoing surgical decompression indicate their postoperative clinical outcome with this scale
次要结局
- Static-2 point discrimination test(12 months postoperatively.)
- 4-point Likert-type scale(12 months postoperatively.)
- Jamar dynamometer (grip strength)(12 months postoperatively.)
研究者
Marco Guidi
Dr., MD
Ente Ospedaliero Cantonale, Bellinzona