Biceps to Flexor Digitorum Superficialis Tendon Transfer for Finger Flexion Reconstruction After Pan-brachial Plexus Injury

May 21, 2026 updated by: Panai Laohaprasitiporn, MD, Siriraj Hospital
This study is a prospective single-arm surgical protocol evaluating biceps-to-flexor digitorum superficialis (FDS) tendon transfer using a tensor fascia lata graft for restoration of finger flexion in patients with traumatic pan-brachial plexus injury (pan-BPI). Finger flexion reconstruction in intrinsic-minus hands remains challenging, as conventional flexor digitorum profundus (FDP)-based reconstructions may result in clawing and ineffective grasp. The proposed technique aims to improve metacarpophalangeal and proximal interphalangeal joint flexion to enhance functional grasp. Eligible patients are those with pan-BPI who previously underwent nerve transfer and achieved elbow flexion strength of at least Medical Research Council (MRC) grade 4. Patients with significant joint stiffness, severe forearm soft tissue injury, or insufficient elbow flexion strength are excluded. The procedure consists of staged reconstruction followed by tendon transfer with tensor fascia lata graft interposition. Postoperative management includes 4 weeks of immobilization and progressive rehabilitation. The primary outcome is functional finger flexion, while secondary outcomes include complications and reoperation rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Traumatic pan-brachial plexus injury (pan-BPI) results in severe upper limb dysfunction, with finger flexion restoration remaining challenging. FDP-based reconstructions often produce clawing and ineffective grasp in intrinsic-minus hands. This study proposes biceps-to-FDS tendon transfer using a tensor fascia lata graft to improve MCP and PIP flexion and enhance grasp. This is a prospective single-arm surgical protocol. Eligible patients include those with pan-BPI who have undergone nerve transfer and achieved elbow flexion at least MRC grade 4. Patients with joint stiffness, severe forearm soft tissue injury, or inadequate elbow strength are excluded. The procedure involves staged reconstruction, followed by tendon transfer with graft interposition. Postoperatively, immobilization is maintained for 4 weeks, with gradual rehabilitation. Primary outcome is functional finger flexion. Secondary outcomes include complications and reoperation.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Brachial plexus injury patients with successful nerve transfer surgery for elbow flexion
  • Elbow flexion motor power at least grade 4

Exclusion Criteria:

  • Stiffness of proximal interphalangeal (PIP) joint
  • Stiffness of metacarpophalangeal (MCP) joint
  • Severe soft tissue injury around the forearm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biceps to FDS transfer
Patients with traumatic pan-brachial plexus injury without spontaneous recovery underwent staged reconstruction to restore upper extremity function. Initial nerve transfer procedures included phrenic nerve transfer to the suprascapular nerve for shoulder stabilization and spinal accessory or intercostal nerve transfer to the musculocutaneous nerve or motor branch to the biceps for elbow flexion restoration. Secondary procedures, including wrist arthrodesis and first carpometacarpal joint fusion, were performed to optimize hand positioning for grasp. After patient selection, those with elbow flexion strength of at least Medical Research Council (MRC) grade 4 underwent biceps-to-flexor digitorum superficialis (FDS) tendon transfer using tensor fascia lata as an interposition tendon graft. Patients with finger joint stiffness, severe forearm soft tissue injury, or elbow flexion strength less than MRC grade 4 were excluded.
Procedure: Biceps to FDS tendon transfer
All procedures were performed under general anesthesia. An S-shaped incision was made over the anterior elbow to identify and mobilize the biceps tendon to its insertion at the radial tuberosity, followed by division of the bicipital aponeurosis. A second incision was made in the distal forearm to identify the flexor digitorum superficialis (FDS) tendon. The tendon gap was measured to determine graft length. A tensor fascia lata graft was harvested from the lateral thigh, tubularized, and used as an interposition tendon graft. The graft was attached to the biceps tendon using the Pulvertaft technique with nonabsorbable sutures, then passed through a subfascial tunnel to the distal forearm to prevent bowstringing. With the elbow flexed at 90° and fingers in full flexion, the distal graft was woven into the FDS tendons using the Pulvertaft technique. Transfer tension was confirmed by assessing the tenodesis effect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Finger flexion motor power
Time Frame: From enrollment to at least 3 months after surgery
Finger flexion motor power was assessed using the Medical Research Council (MRC) grading system at postoperative follow-up visits for a minimum of 3 months after surgery. Motor strength was graded on a scale from M0 to M5, where M0 indicates no visible muscle contraction and M5 indicates normal muscle strength against full resistance. Functional finger flexion strength during grasp was evaluated clinically by the treating surgeon.
From enrollment to at least 3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elbow flexion motor power
Time Frame: From enrollment to at least 3 months after surgery
Elbow flexion motor power was assessed using the Medical Research Council (MRC) grading system at postoperative follow-up visits for a minimum of 3 months after surgery. Motor strength was graded on a scale from M0 to M5, where M0 indicates no visible muscle contraction and M5 indicates normal muscle strength against full resistance. Elbow flexion strength was evaluated clinically by the treating surgeon.
From enrollment to at least 3 months after surgery
Tendon rupture
Time Frame: From enrollment to at least 3 months after surgery
Tendon rupture was assessed as a postoperative complication during follow-up visits for a minimum of 3 months after surgery. Tendon rupture was diagnosed clinically based on loss of active finger flexion or loss of previously achieved motor function at the tendon transfer site, with additional imaging performed when clinically indicated. The incidence of tendon rupture and the need for reoperation were recorded.
From enrollment to at least 3 months after surgery
Finger stiffness
Time Frame: From enrollment to at least 3 months after surgery
Finger stiffness related to excessive tension of the tendon transfer was assessed as a postoperative complication during follow-up visits for a minimum of 3 months after surgery. The complication was defined as limitation of passive and/or active finger motion associated with excessive tightness of the tendon transfer, resulting in impaired hand opening or functional finger movement. Clinical evaluation was performed by the treating surgeon, and the incidence of stiffness and requirement for additional intervention were recorded.
From enrollment to at least 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Investigators

  • Principal Investigator: Panai Laohaprasitiporn, MD, Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

May 21, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SIRB ID: 742/2568(IRB2)
  • COA no. Si 745/2025 (Other Identifier: Siriraj Institutional Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data might be available upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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