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

NCT07184658 | Completed

• 2 other identifiers: 2025-11982425035
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Tendon Adhesion

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months after tendon repair

Secondary Outcomes (5)

• Pain score (VAS)

  6 weeks and 3 months after surgery

• TAM-% at 6 weeks after surgery

  6 weeks after tendon repair

• Michigan Hand Questionnaire (MHQ) score

  3 months after surgery

• Tendon rupture rate

  Within 3 months after surgery

• Infection rate

  Within 3 months after surgery

Study Arms (2)

Intervention Group - Ultrasound-guided Saline Injection

EXPERIMENTAL

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

Control Group - Standard Care

NO INTERVENTION

Patients will receive standard postoperative care after tendon repair without saline injection.

Interventions

Ultrasound-guided peritendinous saline injection PROCEDURE

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

Intervention Group - Ultrasound-guided Saline Injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60 years. Diagnosed with flexor tendon rupture. Scheduled for surgical tendon repair.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kai Wang: lead

Study Sites (1)

Shanghai 6th People's Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (6)

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• 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: 24342071 BACKGROUND

• 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: 22317983 BACKGROUND

• 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.

  PMID: 24900904 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Shen LIU, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study; no masking will be applied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Department of Orthopaedics

Model Details: 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).

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 22, 2025
• Study Start: September 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2025-09

Locations

CN (1)