Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:34 PM
Study NCT ID:
NCT07382193
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-02
First Post:
2026-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Eight-Strand Flexor Tendon Repair Without Splinting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-26', 'studyFirstSubmitDate': '2026-01-26', 'studyFirstSubmitQcDate': '2026-01-26', 'lastUpdatePostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Active Motion (Strickland Score)', 'timeFrame': '6 weeks and 6 months post-surgery', 'description': 'Total active motion of the injured finger(s) measured using the Strickland and Glogovac score via handheld goniometer, assessing flexion excursion.'}], 'secondaryOutcomes': [{'measure': 'Grip Strength', 'timeFrame': '6 weeks and 6 months post-surgery', 'description': 'Grip strength of the injured hand measured using a standard hand dynamometer.'}]}, 'conditionsModule': {'keywords': ['Eight-strand repair', 'Flexor tendon injury', 'no splint'], 'conditions': ['Flexor Tendon Injury', 'Splints', 'Flexor Tendon Repair', 'Flexor Tendon']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAll 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.\n\nUnlike 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.\n\nPatients 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18+ years).\n* Single or multiple clean-cut flexor tendon injuries.\n* Primary repair performed within 2 weeks.\n* Patients with concurrent digital nerve injuries will include if the nerve could be directly repaired.\n\nExclusion Criteria:\n\n* Crush or avulsion injuries.\n* Associated fractures or neurovascular compromise.\n* Recurrent or chronic tendon injuries.'}, 'identificationModule': {'nctId': 'NCT07382193', 'briefTitle': 'Evaluation of Eight-Strand Flexor Tendon Repair Without Splinting', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Evaluation of the Eight - Strand Repair of Flexor Tendon Injuries Without Splinting a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'Eight-strand Tendon Repair'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident at Orthopaedics and Traumatology Department, Assiut University', 'investigatorFullName': 'Abdalrhaman Mohamed Nasr Eldin Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}