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

Pilot Study of Arteriovenous Loop Graft for Free Functional Gracilis Transfer in Brachial Plexus Injured Patients With Insufficient Flow of Donor Artery

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.

Study Overview

• Status: Completed
• Conditions: Brachial Plexus Injury
• Intervention / Treatment: Procedure: Arteriovenous loop graft

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arteriovenous loop graft; 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; 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.; Other Names: AV loop graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viability of the flap	Survival of the flap after the surgery	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor power	Medical Research Council (MRC) grading for motor power assessment	12 months, 18 months
Complications	Bleeding, infection, blood transfusion, stroke, embolism, thrombosis	1 month
Operative time	Total operative time including flap revision surgery or other related complications	1 month

Collaborators and Investigators

• Sponsor: Siriraj Hospital
• Investigators: Principal Investigator: Panai Laohaprasitiporn, MD, Siriraj Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2015
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: May 26, 2024
• First Submitted That Met QC Criteria: May 26, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: brachial plexus palsy; brachial plexus injury; free functional muscle transfer; arteriovenous loop graft; subclavian artery injury; axillary artery injury
• Other Study ID Numbers: 652/2556(EC4)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No