Biceps to Flexor Digitorum Superficialis Tendon Transfer for Finger Flexion Reconstruction After Pan-brachial Plexus Injury
21 мая 2026 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
17
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Bangkok
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Bangkok Noi, Bangkok, Таиланд, 10700
- Siriraj Hospital
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Finger flexion motor power
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Elbow flexion motor power
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Panai Laohaprasitiporn, MD, Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 мая 2014 г.
Первичное завершение (Действительный)
30 июня 2025 г.
Завершение исследования (Действительный)
31 декабря 2025 г.
Даты регистрации исследования
Первый отправленный
18 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
21 мая 2026 г.
Первый опубликованный (Действительный)
26 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
26 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
21 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- SIRB ID: 742/2568(IRB2)
- COA no. Si 745/2025 (Другой идентификатор: Siriraj Institutional Review Board)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕ РЕШЕНО
Описание плана IPD
The data might be available upon request.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .