Biceps to Flexor Digitorum Superficialis Tendon Transfer for Finger Flexion Reconstruction After Pan-brachial Plexus Injury
21 maja 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
17
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Bangkok
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Bangkok Noi, Bangkok, Tajlandia, 10700
- Siriraj Hospital
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Finger flexion motor power
Ramy czasowe: From enrollment to at least 3 months after surgery
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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.
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From enrollment to at least 3 months after surgery
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Elbow flexion motor power
Ramy czasowe: From enrollment to at least 3 months after surgery
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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.
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From enrollment to at least 3 months after surgery
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Tendon rupture
Ramy czasowe: From enrollment to at least 3 months after surgery
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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.
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From enrollment to at least 3 months after surgery
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Finger stiffness
Ramy czasowe: From enrollment to at least 3 months after surgery
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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.
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From enrollment to at least 3 months after surgery
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Panai Laohaprasitiporn, MD, Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- Maldonado AA, Poppler L, Loosbrock Rn MF, Spinner RJ, Bishop AT, Shin AY. Restoration of Grasp after Single-Stage Free Functioning Gracilis Muscle Transfer in Traumatic Adult Pan-Brachial Plexus Injury. Plast Reconstr Surg. 2023 Jan 1;151(1):133-142. doi: 10.1097/PRS.0000000000009787. Epub 2022 Oct 11.
- Hara Y, Nishiura Y, Yoshii Y, Asakawa S, Matsumoto Y, Ochiai N. Reconstruction of hook grip function of the fingers in patients with traumatic brachial plexus injury. J Hand Surg Eur Vol. 2022 Apr;47(4):399-404. doi: 10.1177/17531934211054968. Epub 2021 Oct 29.
- Oberlin C, Durand S, Fox M, Belkheyar Z. Transfer of the recovered biceps to the long flexors of the digits to restore grip function following complete traumatic brachial plexus palsy. Chir Main. 2010 Jun;29(3):167-71. doi: 10.1016/j.main.2010.03.010.
- Gousheh J, Arasteh E. Upper limb functional restoration in old and complete brachial plexus paralysis. J Hand Surg Eur Vol. 2010 Jan;35(1):16-22. doi: 10.1177/1753193409348182. Epub 2009 Oct 20.
- Goubier JN, Teboul F. Restoration of active fingers flexion with tensor fascia lata transfer in total brachial plexus palsy. Tech Hand Up Extrem Surg. 2009 Mar;13(1):1-3. doi: 10.1097/BTH.0b013e3181818832.
- DeGeorge BR Jr, Becker HA, Faryna JH, Spinner RJ, Bishop AT, Shin AY. Outcomes of Muscle Brachialis Transfer to Restore Finger Flexion in Brachial Plexus Palsy. Plast Reconstr Surg. 2017 Aug;140(2):307e-317e. doi: 10.1097/PRS.0000000000003563.
- Bertelli JA, Ghizoni MF. Brachialis muscle transfer to reconstruct finger flexion or wrist extension in brachial plexus palsy. J Hand Surg Am. 2006 Feb;31(2):190-6. doi: 10.1016/j.jhsa.2005.09.020.
- Doi K, Sakai K, Kuwata N, Ihara K, Kawai S. Reconstruction of finger and elbow function after complete avulsion of the brachial plexus. J Hand Surg Am. 1991 Sep;16(5):796-803. doi: 10.1016/s0363-5023(10)80138-8.
- Shen YD, Zheng MX, Hua XY, Qiu YQ, Hu KJ, Xu WD. Brachialis muscle transfer for reconstructing digital flexion after brachial plexus injury or forearm injury. J Hand Surg Eur Vol. 2018 Mar;43(3):259-268. doi: 10.1177/1753193417730656. Epub 2017 Sep 13.
- Kummari VK, Bhardwaj P, Varadharajan V, Madhusudhan NC, Venkatramani H, Raja Sabapathy S. Restoration of Hand Function in Isolated Lower Brachial Plexus Injury with Brachioradialis to Flexor Pollicis Longus and Biceps to Flexor Digitorum Profundus Transfer. J Hand Surg Asian Pac Vol. 2022 Aug;27(4):599-606. doi: 10.1142/S2424835522500655. Epub 2022 Aug 11.
- Doi K, Hattori Y, Sakamoto S, Dodakundi C, Satbhai NG, Montales T. Current Procedure of Double Free Muscle Transfer for Traumatic Total Brachial Plexus Palsy. JBJS Essent Surg Tech. 2013 Aug 28;3(3):e16. doi: 10.2106/JBJS.ST.M.00010. eCollection 2014 Sep.
- Doi K, Hattori Y, Tan SH, Dhawan V. Basic science behind functioning free muscle transplantation. Clin Plast Surg. 2002 Oct;29(4):483-95, v-vi. doi: 10.1016/s0094-1298(02)00020-2.
- Wang SF, Li PC, Xue YH, Li F, Berger AJ, Bhatia A. Direct Repair of the Lower Trunk to Residual Nerve Roots for Restoration of Finger Flexion After Total Brachial Plexus Injury. J Hand Surg Am. 2021 May;46(5):423.e1-423.e8. doi: 10.1016/j.jhsa.2020.09.023. Epub 2020 Dec 14.
- Yang G, Chang KW, Chung KC. A Systematic Review of Contralateral C7 Transfer for the Treatment of Traumatic Brachial Plexus Injury: Part 1. Overall Outcomes. Plast Reconstr Surg. 2015 Oct;136(4):794-809. doi: 10.1097/PRS.0000000000001494.
- Lanier ST, Hill JR, James AS, Rolf L, Brogan DM, Dy CJ. Approach to the Pan-brachial Plexus Injury: Variation in Surgical Strategies among Surgeons. Plast Reconstr Surg Glob Open. 2020 Nov 24;8(11):e3267. doi: 10.1097/GOX.0000000000003267. eCollection 2020 Nov.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 maja 2014
Zakończenie podstawowe (Rzeczywisty)
30 czerwca 2025
Ukończenie studiów (Rzeczywisty)
31 grudnia 2025
Daty rejestracji na studia
Pierwszy przesłany
18 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
21 maja 2026
Pierwszy wysłany (Rzeczywisty)
26 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
26 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
21 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- SIRB ID: 742/2568(IRB2)
- COA no. Si 745/2025 (Inny identyfikator: Siriraj Institutional Review Board)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Opis planu IPD
The data might be available upon request.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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