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

21 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

17

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Tailandia
    • Bangkok
      • Bangkok Noi, Bangkok, Tailandia, 10700
        • Siriraj Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Finger flexion motor power
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Elbow flexion motor power
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Siriraj Hospital

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2014

Completamento primario (Effettivo)

30 giugno 2025

Completamento dello studio (Effettivo)

31 dicembre 2025

Date di iscrizione allo studio

Primo inviato

18 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 maggio 2026

Primo Inserito (Effettivo)

26 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

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INDECISO

Descrizione del piano IPD

The data might be available upon request.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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