Comparing Two Skin Incisions for Flexor Tendon Repair
NCT07596017
Flexor Tendon Injury, Incision, Surgical
View Trial DetailsNCT Number: NCT07382193
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 weeks and 6 months post-surgery
Grip strength of the injured hand measured using a standard hand dynamometer.
Assiut University
Other
Evaluation of the Eight - Strand Repair of Flexor Tendon Injuries Without Splinting a Prospective Cohort Study
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