跳至主要内容
临床试验/NCT01887145
NCT01887145已完成不适用

Endoscopic Versus Open Carpal Tunnel Release: 10 to 15 Years Follow-up of a Randomized Controlled Trial

Region Skane0 个研究点目标入组 124 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Region Skane
入组人数
124
主要终点
Change in CTS symptom severity score

研究概览

简要总结

No randomized trials have compared long-term outcomes following endoscopic and open carpal tunnel release in patients with carpal tunnel syndrome (CTS). The investigators conducted a single-center randomized controlled trial between January 1998 and December 2002, including 128 patients (25 to 60 years) with clinically diagnosed and electrophysiologically confirmed idiopathic CTS. The outcome measures included the validated CTS symptom severity and functional status scales completed at baseline and 1 year postoperatively. The trial showed that the 1-year outcomes of open and endoscopic carpal tunnel release regarding symptoms and function were equivalent. This extended follow-up of the randomized trial will primarily measure the symptom outcomes at 10-15 years after surgery. A questionnaire will be sent by mail to the patients. The questionnaire will consist of the CTS symptom severity and functional status scales, the 6-item CTS symptoms scale (CTS-6), the 11-item disabilities of the arm, shoulder and hand (QuickDASH), the 2-item palmar pain scale, and a visual analog scale about treatment satisfaction. The patients will also be asked about whether they had undergone further surgery for CTS in the same or contralateral hand after their operation in the randomized trial. The completed questionnaires will be scanned into a database. The scores for the different scales will be calculated. Analysis will include comparison between the open and endoscopic groups as well as within-group changes of scores from 1 year to 10-15 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in CTS symptom severity score

时间窗: Baseline to 10-15 years postoperatively

次要结局

  • Patient satisfaction with the results of surgery(10-15 years postoperatively)
  • Change in CTS symptom severity score(1 year to 10-15 years postoperatively)
  • Rate of repeat surgery(10-15 years postoperatively)
  • Change in CTS functional status score(from baseline and 1 year to 10-15 years postoperatively)
  • Residual pain in the scar or proximal palm(10-15 years postoperatively)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

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