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

Not Applicable

• Conditions: Brachial Plexus Injury
• Interventions: Procedure: Arteriovenous loop graft

• Registration Number: NCT06437990
• Lead Sponsor: Siriraj Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-19
• Primary Completion: 2024-04-30
• Status Verified: 2024-05
• Study First Submitted: 2024-05-26
• Study First Submitted QC: 2024-05-26
• Last Update Submitted: 2024-05-26
• Study First Posted: 2024-05-31
• Last Update Posted: 2024-05-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arteriovenous loop graft	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.

Primary Outcome Measures

Name	Time	Method
Viability of the flap	1 month	Survival of the flap after the surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkoknoi, Bangkok, Thailand