Evaluation of Eight-Strand Flexor Tendon Repair Without Splinting

NCT07382193 | Not Yet Recruiting

• 1 other identifier: Eight-strand Tendon Repair
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Flexor Tendon Injury; Splints; Flexor Tendon Repair; Flexor Tendon

Keywords

Eight-strand repair; Flexor tendon injury; no splint

Outcome Measures

Primary Outcomes (1)

• Total Active Motion (Strickland Score)

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

  6 weeks and 6 months post-surgery

Secondary Outcomes (1)

• Grip Strength

  6 weeks and 6 months post-surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) presenting to Assiut University Hospitals with single or multiple clean-cut flexor tendon injuries in zone II, eligible for primary repair within 2 weeks of injury. Concurrent directly repairable digital nerve injuries are included. Crush/avulsion injuries, associated fractures, neurovascular compromise, or recurrent/chronic cases are excluded. Target enrollment: 40 patients.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Orthopaedics and Traumatology Department, Assiut University

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01