Arteriovenous Loop Graft for Free Functional Gracilis Transfer in Brachial Plexus Surgery

NCT06437990 | Completed

• 1 other identifier: 652/2556(EC4)
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Free functional muscle transfer (FFMT) using the gracilis muscle as a donor muscle has become a standard treatment for reconstructing late-onset brachial plexus injuries. Successful implementation of this procedure relies on the availability of functional donor vessels in the injured limb to supply the muscle flap. However, some brachial plexus injuries are accompanied by subclavian or axillary artery injuries, which compromise the viability of the muscle flap due to insufficient vascular supply. To address this, arteriovenous (AV) loop grafts have been employed to extend donor vessels to the flap and have been utilized in various body regions, including the upper extremity. Despite their widespread use, AV loop grafts have not been previously utilized in FFMT for late-onset brachial plexus injuries with concurrent subclavian or axillary artery injuries. This study aimed to assess the feasibility of this surgical approach and report the long-term outcomes of the procedure.

Conditions

Brachial Plexus Injury

Keywords

brachial plexus injury; brachial plexus palsy; free functional muscle transfer; arteriovenous loop graft; subclavian artery injury; axillary artery injury

Outcome Measures

Primary Outcomes (1)

• Viability of the flap

  Survival of the flap after the surgery

  1 month

Secondary Outcomes (3)

• Motor power

  12 months, 18 months

• Complications

  1 month

• Operative time

  1 month

Study Arms (1)

Arteriovenous loop graft

EXPERIMENTAL

A saphenous vein graft was used to create an arteriovenous loop from the common carotid artery to the external jugular vein, providing vascular supply for a free functional gracilis muscle flap in patients with late-onset brachial plexus injury.

Procedure: Arteriovenous loop graft

Interventions

Arteriovenous loop graft PROCEDURE

Using saphenous vein graft to create an arteriovenous loop from the common carotid artery to the external jugular vein, providing vascular supply for a free functional gracilis muscle flap in patients with late-onset brachial plexus injury with concomitant subclavian or axillary artery injury.

Also known as: AV loop graft

Arteriovenous loop graft

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age equal or more than 20 years old
• Patients with brachial plexus injury with depletion of blood flow to the injured limb which confirmed by abnormal computed tomography arteriogram

You may not qualify if:

• Patients who had sufficient thoraco-acromial or thoraco-dorsal artery blood flow for standard free functional muscle transfer operation without the need of an AV loop graft

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (1)

• Limthongthang R, Wongtrakul S, Laohaprasitiporn P, Monteerarat Y, Vathana T. Free Functional Muscle Transfer in Brachial Plexus Injury Patients With Subclavian Artery Injury Using Arteriovenous Loop Grafts. Microsurgery. 2025 Jan;45(1):e70020. doi: 10.1002/micr.70020.

  PMID: 39775958 DERIVED

Study Officials

• Panai Laohaprasitiporn, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Late-onset brachial plexus injury patient with concomitant subclavian or axillary artery injury

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: May 31, 2024
• Study Start: November 19, 2015
• Primary Completion: April 30, 2024
• Study Completion: July 31, 2024
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)