Evaluation of Eight-Strand Flexor Tendon Repair Without Splinting

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07382193

Enrollment

Registered

2026-02-02

Start date

2026-03-01

Completion date

2027-04-01

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flexor Tendon, Flexor Tendon Injury, Flexor Tendon Repair, Splints

Keywords

Eight-strand repair, Flexor tendon injury, no splint

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Total Active Motion (Strickland Score)	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

Measure	Time frame	Description
Grip Strength	6 weeks and 6 months post-surgery	Grip strength of the injured hand measured using a standard hand dynamometer.

Outcome results