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NCT Number: NCT07382193

Evaluation of Eight-Strand Flexor Tendon Repair Without Splinting

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Total Active Motion (Strickland Score)

    Time frame: 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.

Secondary outcomes

  1. Grip Strength

    Time frame: 6 weeks and 6 months post-surgery

    Grip strength of the injured hand measured using a standard hand dynamometer.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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