An interventional study of Ultrasound-guided peritendinous saline injection in Tendon Adhesion, sponsored by Kai Wang. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Kai Wang · Not applicable, Interventional, and Treatment
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.
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.
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.
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.
Kai Wang is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Age between 18 and 60 years. Diagnosed with flexor tendon rupture. Scheduled for surgical tendon repair.
Exclusion Criteria:
Associated 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.
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.
Procedure: Ultrasound-guided peritendinous saline injection
Patients will receive standard postoperative care after tendon repair without 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.
Also known as: Normal saline injection
Total Active Motion Percentage (TAM-%) of the injured finger at 3 months after surgery
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.
Time frame: 3 months after tendon repair
Pain score (VAS)
Visual Analog Scale (0-10), where 0 = no pain and 10 = worst imaginable pain.
Time frame: 6 weeks and 3 months after surgery
TAM-% at 6 weeks after surgery
Same calculation method as the primary outcome, evaluated at an earlier time point.
Time frame: 6 weeks after tendon repair
Michigan Hand Questionnaire (MHQ) score
Patient-reported outcome measure assessing hand function, activities of daily living, pain, work performance, aesthetics, and satisfaction.
Time frame: 3 months after surgery
Tendon rupture rate
Incidence of tendon rupture confirmed by clinical examination or imaging.
Time frame: Within 3 months after surgery
Infection rate
Incidence of superficial or deep surgical site infections diagnosed according to clinical and laboratory criteria.
Time frame: Within 3 months after surgery
Plan to share: Undecided — Individual participant data will not be shared due to concerns regarding patient privacy and institutional regulations.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Kai Wang