Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome
2015年5月5日 更新者:Region Skane
Endoscopic Versus Open Carpal Tunnel Release: 10 to 15 Years Follow-up of a Randomized Controlled Trial
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.
研究概览
研究类型
介入性
注册 (实际的)
124
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
25年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria (original trial):
- Primary idiopathic carpal tunnel syndrome
- age 25-60 years
- currently employed
- duration of symptoms of at least three months
- inadequate response to six weeks' treatment with wrist splint
- symptoms of classic or probable carpal tunnel syndrome according to the diagnostic criteria in the Katz hand diagram, and nerve conduction test showing median neuropathy at the wrist (distal motor latency ≥4.5 milliseconds, wrist-digit sensory latency ≥3.5 milliseconds, or sensory conduction velocity at the carpal tunnel segment <40 metres/second but no other abnormalities.
Exclusion Criteria (original trial):
Inflammatory joint disease
- diabetes mellitus, thyroid disorder, pregnancy, trauma to the affected hand during the preceding year
- previous carpal tunnel release surgery in the affected hand
- carpal tunnel release surgery in the contralateral hand during the preceding year
- symptoms of carpal tunnel syndrome in the contralateral hand not adequately relieved by splint at the time of enrollment
- current sick leave because of disorders other than carpal tunnel syndrome
- inability to complete questionnaires because of language problem or cognitive disorder.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Open surgery
Open surgery is Open carpal tunnel release
|
Open carpal tunnel release using conventional open technique under local anesthesia and tourniquet.
The incision in the open procedure extended from about 1 cm proximal to 3 cm distal to the wrist crease.
The transverse carpal ligament was divided; no additional procedures were performed.
a soft dressing was applied.
Dressing and sutures were removed 10 days postoperatively.
其他名称:
|
|
实验性的:Endoscopic surgery
Endoscopic surgery is 2-portal endoscopic carpal tunnel release
|
Surgery dwas done under local anesthesia injected at the portal sites only.
Tourniquet was used.
Each of the two skin incisions in the endoscopic procedure was 1 cm long.
With the endoscope inserted from the distal portal and a hook knife inserted from the proximal portal, the transverse carpal ligament was divided from its distal edge to its proximal edge.
Incisions were closed with non-absorbables sutures and a soft dressing was applied.
Sutures were removed 10 days postoperatively.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change in CTS symptom severity score
大体时间:Baseline to 10-15 years postoperatively
|
Baseline to 10-15 years postoperatively
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Rate of repeat surgery
大体时间:10-15 years postoperatively
|
10-15 years postoperatively
|
|
Change in CTS functional status score
大体时间:from baseline and 1 year to 10-15 years postoperatively
|
from baseline and 1 year to 10-15 years postoperatively
|
|
Residual pain in the scar or proximal palm
大体时间:10-15 years postoperatively
|
10-15 years postoperatively
|
|
Patient satisfaction with the results of surgery
大体时间:10-15 years postoperatively
|
10-15 years postoperatively
|
|
Change in CTS symptom severity score
大体时间:1 year to 10-15 years postoperatively
|
1 year to 10-15 years postoperatively
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
CTS-6 score
大体时间:10-15 years postoperatively
|
10-15 years postoperatively
|
|
QuickDASH score
大体时间:10-15 years postoperatively
|
10-15 years postoperatively
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员:Isam Atroshi, MD, PhD、Clinical Sciences, Lund University, Sweden
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Atroshi I, Larsson GU, Ornstein E, Hofer M, Johnsson R, Ranstam J. Outcomes of endoscopic surgery compared with open surgery for carpal tunnel syndrome among employed patients: randomised controlled trial. BMJ. 2006 Jun 24;332(7556):1473. doi: 10.1136/bmj.38863.632789.1F. Epub 2006 Jun 15.
- Atroshi I, Hofer M, Larsson GU, Ranstam J. Extended Follow-up of a Randomized Clinical Trial of Open vs Endoscopic Release Surgery for Carpal Tunnel Syndrome. JAMA. 2015 Oct 6;314(13):1399-401. doi: 10.1001/jama.2015.12208. No abstract available.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年9月1日
初级完成 (实际的)
2014年11月1日
研究完成 (实际的)
2015年1月1日
研究注册日期
首次提交
2013年6月24日
首先提交符合 QC 标准的
2013年6月25日
首次发布 (估计)
2013年6月26日
研究记录更新
最后更新发布 (估计)
2015年5月6日
上次提交的符合 QC 标准的更新
2015年5月5日
最后验证
2015年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.