跳至主要内容
临床试验/NCT03757416
NCT03757416终止不适用

Outcomes After Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome: A Prospective Study

University of Tennessee0 个研究点目标入组 2 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
主要终点
Improvement of Symptoms

研究概览

简要总结

The purpose of this study is to collect data on the clinical and functional outcomes of surgical management for recurrent carpal tunnel syndrome (CTS) using flexor tenosynovectomy. It is hypothesized that the outcomes of patients undergoing flexor tenosynovectomy for recurrent CTS will compare favorably to published data regarding alternative types of surgeries for the same condition.

详细描述

Primary carpal tunnel release (CTR) is the most common surgical procedure of the hand, but reported rates of symptom recurrence are not uncommon. Many surgical techniques have been proposed and reported for management of carpal tunnel syndrome (CTS) symptom recurrence, however there is a paucity of data on flexor tenosynovectomy for management of recurrent CTS.

This study will evaluate clinical and functional outcomes using information from pre- and post-operative physical exams, surgery data, patient-reported satisfaction and symptoms, and scores on functional measures, such as the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Adult patients (> 18 years)
  • Patient of The Plastic Surgery Group/Hayes Hand Center
  • Previous diagnosis of Carpal Tunnel Syndrome
  • Diagnosis of Recurrent Carpal Tunnel Syndrome
  • Underwent primary carpal tunnel release
  • Undergoing isolated flexor tenosynovectomy as secondary procedure

排除标准

  • Had incomplete primary release of transverse carpal ligament
  • Had documented neuroma upon re-exploration
  • Had other soft tissue tumor within carpal tunnel or providing reasonable contribution to neurologic symptoms
  • Experienced fracture or other traumatic injury to wrist after primary carpal tunnel release
  • Diagnosis of osteomyelitis, infectious tenosynovitis or other infectious etiology to area of interest after primary procedure
  • Diagnosis of rheumatoid arthritis, psoriatic arthritis, or other inflammatory arthropathy

结局指标

主要结局

Improvement of Symptoms

时间窗: one year

'Improvement of symptoms' versus 'No change/worsening of symptoms' of carpal tunnel syndrome following flexor tenosynovectomy. Improvement vs worsening of symptoms determined by subjective physician assessment at one-year follow-up as documented through office dictation in the medical record.

次要结局

  • DASH (Disabilities of the Arm, Shoulder, and Hand) score(one year)
  • Patient 'satisfaction'(one year)

研究者

申办方类型
Other
责任方
Sponsor

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