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临床试验/NCT07382193
NCT07382193尚未招募不适用

Evaluation of the Eight - Strand Repair of Flexor Tendon Injuries Without Splinting a Prospective Cohort Study

Assiut University0 个研究点目标入组 40 人开始时间: 2026年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
Total Active Motion (Strickland Score)

研究概览

简要总结

This prospective cohort study evaluates functional outcomes of primary eight-strand flexor tendon repair in zone II without postoperative splinting in 40 adults (≥18 years) at Assiut University Hospitals. Patients undergo wide-awake local anesthesia no tourniquet (WALANT) surgery followed by immediate gentle active motion. Primary outcome: total active motion via Strickland score at 6 weeks and 6 months. Secondary: grip strength, DASH score, patient satisfaction.

详细描述

Flexor tendon injuries in zone II are traditionally managed with postoperative splinting to protect the repair, but this can limit early mobilization and functional recovery. This prospective cohort study aims to evaluate the clinical and functional outcomes of primary flexor tendon repair using an eight-strand core suture technique without postoperative splinting.

All procedures will be performed under wide-awake local anesthesia without a tourniquet (WALANT). The injured tendons will be repaired using an innovative crossed eight-strand core suture technique with PDS 3-0 or 4-0 sutures, depending on tendon size. Standard aseptic technique and microsurgical instruments will be utilized.

Unlike traditional protocols, no splint will be applied postoperatively. Patients will begin gentle, active range-of-motion exercises starting on postoperative day 5. This approach aims to leverage the superior tensile strength of the eight-strand repair to allow early mobilization, potentially reducing adhesion formation and improving outcomes.

Patients will be followed up weekly until 6 weeks, then at 12 weeks, and finally at 6 months post-surgery. Skin sutures will be removed at two weeks.

The primary outcome is Total Active Motion (TAM) assessed using the Strickland and Glogovac score at 6 weeks and 6 months. Secondary outcomes include grip strength and patient-reported function via the Disability of the Arm, Shoulder, and Hand (DASH) questionnaire at the same time points.

研究设计

研究类型
Observational
观察模型
Cohort
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).
  • Single or multiple clean-cut flexor tendon injuries.
  • Primary repair performed within 2 weeks.
  • Patients with concurrent digital nerve injuries will include if the nerve could be directly repaired.

排除标准

  • Crush or avulsion injuries.
  • Associated fractures or neurovascular compromise.
  • Recurrent or chronic tendon injuries.

结局指标

主要结局

Total Active Motion (Strickland Score)

时间窗: 6 weeks and 6 months post-surgery

Total active motion of the injured finger(s) measured using the Strickland and Glogovac score via handheld goniometer, assessing flexion excursion.

次要结局

  • Grip Strength(6 weeks and 6 months post-surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdalrhaman Mohamed Nasr Eldin Mohamed

Resident at Orthopaedics and Traumatology Department, Assiut University

Assiut University

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