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

21 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

17

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Finger flexion motor power
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Elbow flexion motor power
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Siriraj Hospital

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 mei 2014

Primaire voltooiing (Werkelijk)

30 juni 2025

Studie voltooiing (Werkelijk)

31 december 2025

Studieregistratiedata

Eerst ingediend

18 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 mei 2026

Eerst geplaatst (Werkelijk)

26 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

21 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

The data might be available upon request.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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