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Evaluation of Eight-Strand Flexor Tendon Repair Without Splinting

A

Assiut University

Status

Begins enrollment this month

Conditions

Splints
Flexor Tendon
Flexor Tendon Injury
Flexor Tendon Repair

Study type

Observational

Funder types

Other

Identifiers

NCT07382193
Eight-strand Tendon Repair

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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