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临床试验/NCT06747962
NCT06747962尚未招募不适用

A1 Pulley Release and Pull-out Tenolysis Versus Simple A1 Pulley Release in Trigger Fingers and Thumb. a Randomized Controlled Trial

Eleni Karagergou2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
2
主要终点
Visual Analog Scale (VAS) for pain relief

研究概览

简要总结

Trigger finger is a common tendinopathy and clinically presents with painful catching or popping as the patient flexes and extends the digit, due to mechanical impingement of the thickened flexor tendons as they pass through a narrow tendon sheath canal at the level of the metacarpal head. If conservative management with corticosteroid injection and splinting fails or if symptoms recur, surgery and division of the A1 pulley are indicated. Traction (or pull- out) tenolysis is a maneuver based on pulling of the flexor tendons out of the wound, to release any adhesions that might have occurred due to long- standing triggering. Although it has been associated with postoperative pain and stiffness, no robust evidence exists to support its benefit or not. In view of the low quality evidence regarding the pros and cons of traction (or pull-out) tenolysis following A1 pulley release, the investigators will compare simple A1 pulley release versus A1 pulley release and pull-out tenolysis in a prospective randomized study design. Hypothesis of the study is that the pull- out tenolysis yields better results in terms of total active range of movement, pinch and grip strength, pain and quick-DASH scoring when compared to simple pulley release. The confirmation of the hypothesis will justify the use of pull-out tenolysis as a means of breaking any tendon adhesions and returning to normal function sooner. On the contrary, if the pull-out tenolysis is linked to a less favorable functional outcome, simple A1 pulley release will be recommended.

详细描述

Trigger finger is a common condition that can cause hand pain and disability. It involves entrapment of the flexor tendons of the fingers and thumb within their flexor tendon sheath at the level of the metacarpal head. This phenomenon is due to the mechanical impingement of the thickened flexor tendons as they pass through a narrow tendon sheath canal. It can cause painful catching or popping as the patient flexes and extends the digit. On occasion, the digit will lock in flexion and require passive manipulation to extend. Initial management can be conservative with corticosteroid injection and splinting. If conservative management fails or if symptoms recur, surgical release of the A1 pulley is indicated. This is a common procedure which is performed under local anaesthesia. Intraoperatively, following division of A1 pulley, a traction tenolysis is occasionally performed by some surgeons. This maneuver, which is based on pulling of the flexor tendons out of the wound, is believed to release any adhesions that might have occurred due to long- standing triggering but it has been reported to result in prolonged postoperative pain and stiffness. However, there is no robust evidence to support a less favorable outcome following traction tenolysis. Aim of the study: In view of the low quality evidence regarding the pros and cons of traction (or pull-out) tenolysis following A1 pulley release, the investigators will compare simple A1 pulley release versus A1 pulley release and pull-out tenolysis in a prospective randomized study design. Hypothesis of the study is that the pull-out tenolysis yields better results in terms of total active range of movement, pinch and grip strength, pain and quick-DASH scoring when compared to simple pulley release. The confirmation of the hypothesis will justify the use of pull-out tenolysis as a means of breaking any tendon adhesions and returning to normal function sooner. On the contrary, if the pull- out tenolysis is linked to a less favorable functional outcome, simple A1 pulley release will be recommended. The study will be conducted in accordance with the Declaration of Helsinki and the Guidelines on Good Clinical Practice.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with single trigger finger that failed conservative treatment
  • Patients with single trigger finger that had recurrence of symptoms after conservative treatment

排除标准

  • Patients with limited range of movement before appearance of triggering
  • Patients with osteoarthritis / rheumatoid arthritis
  • Patients that had a second procedure at the same time of trigger finger release (eg carpal tunnel release).

结局指标

主要结局

Visual Analog Scale (VAS) for pain relief

时间窗: 3 months

Comparison of the VAS for pain between the groups. Minimum 0, Maximum 10, higher scores mean a worse outcome

Total active range of motion (AROM) of the affected finger

时间窗: 3 months

Comparison of total (AROM) between the groups. Measurements will be done with a goniometer.

次要结局

  • Grip and Pinch strength(3 months)
  • Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) functional score(3 months)

研究者

发起方
Eleni Karagergou
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eleni Karagergou

Consultant Plastic and Hand Surgeon

Aristotle University Of Thessaloniki

研究点 (2)

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