跳至主要内容
临床试验/NCT04391751
NCT04391751Unknown不适用

Basal Joint Arthroplasty and Carpal Tunnel Release Comparing Single Versus Double Incision. Randomized Clinical Trial

Hospital Universitari Vall d'Hebron Research Institute2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Change of CTS symptoms intensity

研究概览

简要总结

Concomitant carpal tunnel syndrome and basal thumb junt osteoarthritis through a single incision has been described. Case serials have reported good with this technique. Nonetheless, there is a lack of comparative studies evaluating the effectivity and complications of single-incision versus double-incision technique. Only with an randomized clinical trial design it is possible to gain evidence about the advantages of one treatment method over another. The aim of the study is the comparison between two surgical techniques for concomitant carpal tunnel syndrome and basal thumb junt osteoarthritis: single versus double incision techniques.

详细描述

Basal thumb joint osteoarthritis is a common disorder especially among postmenopausal women. In this specific subgroup of patients, radiographic signs appear in up to 40%.

Approximately 28% of those cases are symptomatic. Its pathoanatomy and treatment has been well described. Trapeziometacarpal joint is the most commonly joint requiring treatment for osteoarthritis in the upper extremity, often involving removing the trapezius. The same demographic group is also frequently affected by carpal tunnel syndrome (CTS), which coexists with basal joint arthritis in 18% to 46% of patients. In those cases, a combined surgical approach has been reported to be beneficial. The two conditions have traditionally been treated surgically through separate incisions.

a radial incision for trapeziectomy and standard midline volar carpal tunnel incision for median nerve decompression. Trapeziectomy has been proved to provide some degree of carpal tunnel decompression. However, as previous studies have suggested, release of the transverse carpal ligament should be performed in addition to basal joint arthroplasty incision, as trapeziectomy by itself does not completely decompress the carpal tunnel. The ability to decompress the carpal tunnel during basal joint arthroplasty using a single incision would allow to shorten surgery time, improve appearance, and potentially decrease morbidity compared to a staged or two-incision procedure. We sought to determine whether carpal tunnel release using a single incision during basal joint arthroplasty is as effective as two-incision approach in patients with concomitant CTS and basal thumb joint osteoarthrosis. The secondary hypothesis is that single incision prevents from morbidity associated to a second incision, such as pillar pain, longer surgical procedure, infection rate or necrosis of the skin bridge between incisions

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Concomitant basal joint osteoarthritis and CTS in the ipsilateral extremity.
  • Severe CTS sympthoms wiht positive physical examination findings (eg, Phalen test and Tinel test).
  • Electromyography (EMG) results supporting the diagnosis of CTS.
  • Failed CTS nonsurgical treatment.
  • Basal joint osteoarthritis Eaton stage II or greater
  • Unacceptable pain localized in the basal joint appeared with activity, or reproduced by grind test or direct palpation
  • Failed basal joint osteoarthritis nonsurgical treatment.

排除标准

  • Pregnancy
  • Diabetes mellitus
  • Acute trauma
  • Rheumatoid arthritis
  • Hipothyroidism
  • Hyperthiroidism
  • Posttraumatic arthritis
  • Prior hand surgery procedures
  • Nerve compression at proximal level
  • Other nerve entrapments

结局指标

主要结局

Change of CTS symptoms intensity

时间窗: Preoperatively, 3, 6, and 12 months postoperatively

To assess the CTS symptoms intensity, patients filled out the Boston Carpal Tunnel Questionaire. This questionnaire evaluates symptom's severity (11 items) and functional status (8 items) (1: no complaints, 5 maximum complaints possible). Minimum score is 19 and maximum 95.

次要结局

  • Change of hand function(Preoperatively, 3, 6, and 12 months postoperatively)
  • Change of hand pain(Preoperatively, 3, 6, and 12 months postoperatively)
  • Change of grip strength(Preoperatively, 3, 6, and 12 months postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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