Ultrasound-Guided Multiple Saline Injections for Prevention of Tendon Adhesion: A Randomized Controlled Trial
NCT ID: NCT07184658
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
136 participants
INTERVENTIONAL
2025-09-01
2026-03-31
Brief Summary
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In 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).
The 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.
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Detailed Description
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Our 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.
This 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.
Safety 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.
The 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Group - Ultrasound-guided Saline Injection
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.
Ultrasound-guided peritendinous saline injection
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.
Control Group - Standard Care
Patients will receive standard postoperative care after tendon repair without saline injection.
No interventions assigned to this group
Interventions
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Ultrasound-guided peritendinous saline injection
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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Kai Wang
OTHER
Responsible Party
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Kai Wang
Principal Investigator, Department of Orthopaedics
Principal Investigators
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Shen LIU, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai 6th Peoples Hospital Affiliated to Shanghai Jiaotong University School of Medicine Department of Orthopaedic Surgery
Locations
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Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Related Links
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Related Info
Other Identifiers
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82425035
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2025-119
Identifier Type: -
Identifier Source: org_study_id
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