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Ultrasound-Guided Multiple Saline Injections for Prevention of Tendon Adhesion: A Randomized Controlled Trial

A Prospective Randomized Controlled Trial of Ultrasound-Guided Repeated Normal Saline Injections for Preventing and Treating Tendon Adhesion

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07184658
Enrollment
136
Registered
2025-09-22
Start date
2025-09-01
Completion date
2026-03-31
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tendon Adhesion

Keywords

Ultrasound-guided injection, Normal saline, Tendon adhesion prevention, Flexor tendon repair, Hand surgery, Randomized controlled trial

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREUltrasound-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.

Sponsors

Kai Wang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

This is an open-label study; no masking will be applied.

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Total Active Motion Percentage (TAM-%) of the injured finger at 3 months after surgery3 months after tendon repairTAM-% 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.

Secondary

MeasureTime frameDescription
Pain score (VAS)6 weeks and 3 months after surgeryVisual Analog Scale (0-10), where 0 = no pain and 10 = worst imaginable pain.
TAM-% at 6 weeks after surgery6 weeks after tendon repairSame calculation method as the primary outcome, evaluated at an earlier time point.
Michigan Hand Questionnaire (MHQ) score3 months after surgeryPatient-reported outcome measure assessing hand function, activities of daily living, pain, work performance, aesthetics, and satisfaction.
Tendon rupture rateWithin 3 months after surgeryIncidence of tendon rupture confirmed by clinical examination or imaging.
Infection rateWithin 3 months after surgeryIncidence of superficial or deep surgical site infections diagnosed according to clinical and laboratory criteria.

Countries

China

Contacts

PRINCIPAL_INVESTIGATORShen LIU, MD

Shanghai 6th Peoples Hospital Affiliated to Shanghai Jiaotong University School of Medicine Department of Orthopaedic Surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026