Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT07184658
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound-Guided Multiple Saline Injections for Prevention of Tendon Adhesion: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label study; no masking will be applied.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective, single-center, randomized controlled trial with parallel assignment. Patients undergoing flexor tendon repair will be randomly allocated to either the intervention group (ultrasound-guided saline injections) or the control group (no injection).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2025-09-18', 'studyFirstSubmitQcDate': '2025-09-18', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Active Motion Percentage (TAM-%) of the injured finger at 3 months after surgery', 'timeFrame': '3 months after tendon repair', 'description': 'TAM-% is calculated as the sum of active flexion at the metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints minus the sum of extension deficits, divided by the normal range of motion, multiplied by 100%. It reflects functional recovery and tendon adhesion severity.'}], 'secondaryOutcomes': [{'measure': 'Pain score (VAS)', 'timeFrame': '6 weeks and 3 months after surgery', 'description': 'Visual Analog Scale (0-10), where 0 = no pain and 10 = worst imaginable pain.'}, {'measure': 'TAM-% at 6 weeks after surgery', 'timeFrame': '6 weeks after tendon repair', 'description': 'Same calculation method as the primary outcome, evaluated at an earlier time point.'}, {'measure': 'Michigan Hand Questionnaire (MHQ) score', 'timeFrame': '3 months after surgery', 'description': 'Patient-reported outcome measure assessing hand function, activities of daily living, pain, work performance, aesthetics, and satisfaction.'}, {'measure': 'Tendon rupture rate', 'timeFrame': 'Within 3 months after surgery', 'description': 'Incidence of tendon rupture confirmed by clinical examination or imaging.'}, {'measure': 'Infection rate', 'timeFrame': 'Within 3 months after surgery', 'description': 'Incidence of superficial or deep surgical site infections diagnosed according to clinical and laboratory criteria.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound-guided injection', 'Normal saline', 'Tendon adhesion prevention', 'Flexor tendon repair', 'Hand surgery', 'Randomized controlled trial'], 'conditions': ['Tendon Adhesion']}, 'referencesModule': {'references': [{'pmid': '36794129', 'type': 'BACKGROUND', 'citation': 'Franssen AJPM, Degens JHRJ, Daemen JHT, Laven IEWG, Hulsewe KWE, Vissers YLJ, de Loos ER. Mediastinal staging by thoracic surgeons: are we close to a paradigm shift? J Thorac Dis. 2023 Jan 31;15(1):10-13. doi: 10.21037/jtd-22-1420. Epub 2023 Jan 6. No abstract available.'}, {'pmid': '35122339', 'type': 'BACKGROUND', 'citation': 'Ockun MA, Gercek YC, Demirsoy H, Demirsoy L, Macit I, Oz GC. Comparative evaluation of phenolic profile and antioxidant activity of new sweet cherry (Prunus avium L.) genotypes in Turkey. Phytochem Anal. 2022 Jun;33(4):564-576. doi: 10.1002/pca.3110. Epub 2022 Feb 4.'}, {'pmid': '34932626', 'type': 'BACKGROUND', 'citation': 'Yasmeen R, Zahid B, Alyas S, Akhtar R, Zahra N, Kouser S, Hashmi AS, Athar M, Tayyab M, Anjum AA. Ameliorative effects of Lactobacillus against Aflatoxin B1. Braz J Biol. 2021 Dec 20;84:e250517. doi: 10.1590/1519-6984.250517. eCollection 2021.'}, {'pmid': '24342071', 'type': 'BACKGROUND', 'citation': 'Sueiras M, Sahuquillo J, Garcia-Lopez B, Sanchez-Guerrero A, Poca MA, Santamarina E, Riveiro M, Fabricius M, Strong AJ. [Cortical spreading depolarization phenomena in patients with traumatic and ischemic brain injuries. Results of a pilot study]. Med Intensiva. 2014 Oct;38(7):413-21. doi: 10.1016/j.medin.2013.09.008. Epub 2013 Dec 15. Spanish.'}, {'pmid': '22317983', 'type': 'BACKGROUND', 'citation': 'Roy V, Sahni P, Gupta P, Sethi GR, Khanna A. Blood levels of pyrazinamide in children at doses administered under the Revised National Tuberculosis Control Program. Indian Pediatr. 2012 Sep;49(9):721-5. doi: 10.1007/s13312-012-0164-8. Epub 2011 Jan 17.'}, {'pmid': '24900904', 'type': 'BACKGROUND', 'citation': 'Kim HT, Oh JS, Lee JS, Lee TH. Z-lengthening of the Achilles tendon with transverse skin incision. Clin Orthop Surg. 2014 Jun;6(2):208-15. doi: 10.4055/cios.2014.6.2.208. Epub 2014 May 16.'}], 'seeAlsoLinks': [{'url': 'https://www.shsmu.edu.cn/english/info/1085/1228.htm', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This prospective randomized controlled trial aims to evaluate the efficacy and safety of ultrasound-guided repeated normal saline injections for the prevention and treatment of tendon adhesion following flexor tendon repair. Tendon adhesion is a common complication after tendon injury, leading to pain, stiffness, and impaired hand function. Conventional anti-adhesion strategies, such as physical barrier membranes, may induce local inflammation or have limited effectiveness.\n\nIn this study, patients undergoing tendon repair will be randomly assigned to receive either ultrasound-guided peritendinous saline injections at 7, 14, and 21 days after surgery (intervention group) or no injection (control group). The primary outcome is total active motion (TAM-%) at 3 months after surgery. Secondary outcomes include TAM-% at 6 weeks, pain scores (VAS), Michigan Hand Questionnaire (MHQ) scores, infection rate, and tendon rupture rate. A total of 136 patients will be enrolled (68 in each group).\n\nThe findings of this trial will help to establish whether repeated saline injections under ultrasound guidance can effectively prevent tendon adhesion, improve pain and functional outcomes, and ensure tendon healing with minimal complications.', 'detailedDescription': 'Tendon adhesion is one of the most common complications following flexor tendon repair, with an incidence of up to 60%. Adhesion significantly impairs hand function, often leading to a cycle of adhesion formation, surgical release, and recurrent adhesion, which causes long-term disability and high healthcare costs. Current preventive measures mainly rely on physical barrier materials, such as membranes or gels, but these approaches may induce aseptic inflammation and pain, and their long-term effectiveness remains limited.\n\nOur previous research suggested that early peritendinous injection therapy may be more effective than intraoperative application in preventing tendon adhesion. Using dynamic ultrasound, we successfully localized tendon adhesion sites and demonstrated the feasibility of delivering precise peritendinous injections under ultrasound guidance. Based on these findings, we hypothesize that repeated ultrasound-guided saline injections at early postoperative stages can reduce adhesion formation while minimizing the impact on tendon healing.\n\nThis is a prospective, single-center, randomized controlled clinical trial enrolling 136 patients (68 per group) after flexor tendon repair. Patients in the intervention group will undergo ultrasound-guided peritendinous injections of 1 mL normal saline on postoperative days 7, 14, and 21. The control group will receive standard care without injections. Patients will be followed up at 6 weeks and 3 months after surgery. The primary endpoint is total active motion (TAM-%) at 3 months. Secondary endpoints include TAM-% at 6 weeks, visual analog scale (VAS) pain scores, Michigan Hand Questionnaire (MHQ) scores, infection rate, tendon rupture rate, and wound healing time.\n\nSafety will be assessed through physical examinations, laboratory tests (blood count, C-reactive protein, erythrocyte sedimentation rate), and adverse event monitoring. Statistical analysis will be performed using appropriate parametric or non-parametric methods, with significance set at P \\< 0.05.\n\nThe successful completion of this study is expected to provide clinical evidence supporting ultrasound-guided saline injections as a safe, effective, and low-cost strategy for preventing tendon adhesion, improving hand function, and reducing complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge between 18 and 60 years. Diagnosed with flexor tendon rupture. Scheduled for surgical tendon repair.\n\nExclusion Criteria:\n\nAssociated vascular or nerve injury. History of diabetes mellitus. History of non-steroidal anti-inflammatory drug (NSAID) treatment. History of cardiac insufficiency. History of hematologic diseases. History of hepatic or renal dysfunction. History of rheumatologic or autoimmune diseases. History of radiotherapy or chemotherapy. History of corticosteroid treatment. Pregnancy. Currently participating in another clinical trial.'}, 'identificationModule': {'nctId': 'NCT07184658', 'briefTitle': 'Ultrasound-Guided Multiple Saline Injections for Prevention of Tendon Adhesion: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 6th People's Hospital"}, 'officialTitle': 'A Prospective Randomized Controlled Trial of Ultrasound-Guided Repeated Normal Saline Injections for Preventing and Treating Tendon Adhesion', 'orgStudyIdInfo': {'id': '2025-119'}, 'secondaryIdInfos': [{'id': '82425035', 'type': 'OTHER_GRANT', 'domain': 'National Natural Science Foundation of China'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group - Ultrasound-guided Saline Injection', 'description': 'Patients will undergo ultrasound-guided peritendinous injections of 1 mL normal saline at the tendon repair site on postoperative days 7, 14, and 21. The goal is to prevent tendon adhesion and improve functional outcomes.', 'interventionNames': ['Procedure: Ultrasound-guided peritendinous saline injection']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group - Standard Care', 'description': 'Patients will receive standard postoperative care after tendon repair without saline injection.'}], 'interventions': [{'name': 'Ultrasound-guided peritendinous saline injection', 'type': 'PROCEDURE', 'otherNames': ['Normal saline injection'], 'description': 'Under ultrasound guidance, 1 mL of sterile normal saline will be injected peritendinously at the tendon repair site at 7, 14, and 21 days after surgery to reduce adhesion formation and preserve tendon healing.', 'armGroupLabels': ['Intervention Group - Ultrasound-guided Saline Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kai WAHG, MD', 'role': 'CONTACT', 'email': '2019wk@sjtu.edu.cn', 'phone': '+86 19821288715'}], 'facility': "Shanghai 6th People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shen LIU, MD', 'role': 'CONTACT', 'email': 'liushensjtu@sjtu.edu.cn', 'phone': '+86-21-64369181'}, {'name': 'Kai WANG, MD', 'role': 'CONTACT', 'email': '2019wk@sjtu.edu.cn', 'phone': '+8619821288715'}], 'overallOfficials': [{'name': 'Shen LIU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai 6th Peoples Hospital Affiliated to Shanghai Jiaotong University School of Medicine Department of Orthopaedic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual participant data will not be shared due to concerns regarding patient privacy and institutional regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kai Wang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Department of Orthopaedics', 'investigatorFullName': 'Kai Wang', 'investigatorAffiliation': "Shanghai 6th People's Hospital"}}}}