Flexor Hallucis Longus Tendon Transfer VS Gastrocnemius Augmented Flexor Hallucis Longus Tendon Transfer in Management of Achilles Tendon Defect

Официальное название

Isolated Flexor Hallucis Longus Tendon Transfer VS Gastrocnemius Augmented Flexor Hallucis Longus Tendon Transfer in Management of Achilles Tendon Defect: a Randomized Controlled Trial

Обзор

This study aims to compare the functional outcome of Isolated Flexor hallucis longus tendon transfer and Gastrocnemius Augmented Flexor hallucis longus tendon transfer in repair of Achilles tendon defects. Also, compare the two procedures regarding complication rate, time to restore the function, and the need for secondary procedures.

Подробное описание

The Achilles tendon (AT) is the largest and strongest tendon in the human body, yet it is also one of the most commonly ruptured tendons, with an annual incidence of about 18 cases per 100,000 people. Around 75% of Achilles tendon ruptures (ATR) occur in middle-aged patients during sports activity or following trauma. These injuries typically happen in a region 2 to 6 cm above the tendon's attachment to the heel, an area that has a relatively poor blood supply, that reducing the probability of the healing of the tendon by conservative management. Because of the absence of significant pain and the ability to partially maintain plantar flexion, it has been reported that around 10-25% of Achilles tendon rupture (ATR) cases are overlooked or misdiagnosed during the initial medical assessment. The delaying of the diagnosis and by the way the treatment results in a greater separation between the tendon ends, with scar tissue filling the gap leading to lengthening to the gastrocnemius muscle decreasing its tensile forces. This makes the surgical intervention for repair of chronic tendo Achillis rupture necessary to restore normal leg function. Various surgical procedures such as reconstruction with V-Y advanced flap, gastrocnemius turn-down flap, local tendon transfer augments (Flexor hallucis longus (FHL) or peroneus brevis), semitendinosus autograft, free tissue transfer including synthetic grafts and allografts to bridge the gap have been described. Some techniques have been combined, such as tissue advancement and tendon transfer. Multiple studies have been done comparing two or more of the mentioned techniques, but to our knowledge there is no randomized controlled study comparing the isolated FHL tendon transfer to gastrocnemius augmented flexor hallucis longus (GAFHL) tendon transfer.

Вмешательства

• Процедура Flexor hallucis longus tendon transfer
  The FHL tendon will be dissected and transected as far distally as possible. The FHL tendon will be transfixed by Krakow's suture being inserted into the distal 3 cm in the stump to ensure adequate length of the graft inserted within the bony tunnel in the calcaneus.A guide wire with eyelet will be inserted in the calcaneum just anterior to the native AT insertion by a distance 2 mm more than the half of the diameter of the transferred tendon to avoid blow up of the posterior wall of the tunnel.
• Процедура Gastrocnemius augmented Flexor hallucis longus tendon transfer
  The gastrocnemius tendon will be refixed to the calcaneal tuberosity using anchors. According to the size of the defect: If the size of the gap was 4-5 cm, an additional gastrocnemius turndown or V-Y flaps will be done. Turn down flap will be achieved by creating 2 cm wide and 5-6 cm long flap from the gastrocnemius tendon. The most distal 1 cm from the proximal stump will be secured along the lateral border of the flap to prevent its separation from the original stump during tensioning and fixa

Первичные конечные точки

• American Orthopedic Foot and Ankle Society (AOFAS) Score Ankle-Hindfoot Scale [Срок оценки: at 6 months, and 1 year follow up visits]
• Strength Testing with handheld Dynamometry for plantar flexors [Срок оценки: At 3 months, 6 months, and one year follow up visits.]

Вторичные конечные точки (2)

• Rate of complications [Срок оценки: Through study completion, an average of 1 year]
• Foot function index [Срок оценки: at 6 months, and 1 year follow up visits]

Критерии участия

Критерии включения

• Age range: Adolescents and adults with skeletally mature feet (above 12 y in females and 14 years in males).
• Achilles Tendon defects more than 4 cm resulted from acute or chronic rupture, post-debridement defects in case of neglected insertional tendinopathy, spontaneous ruptures due to tendinosis or after tumor resection.

Критерии исключения

• General medical contraindications to surgical interventions
• Calcaneal Fracture, subtalar fusion
• infection or previous surgery in the ipsilateral hindfoot or ankle
• Systemic disease including seronegative inflammatory diseases, spondyloarthropathies or sarcoidosis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Assuit university hospitals — Asyut

Публикации

• Guclu B, Basat HC, Yildirim T, Bozduman O, Us AK. Long-term Results of Chronic Achilles Tendon Ruptures Repaired With V-Y Tendon Plasty and Fascia Turndown. Foot Ankle Int. 2016 Jul;37(7):737-42. doi: 10.1177/1071100716642753. Epub 2016 Apr 1. PMID 27036138
• Nilsson N, Gunnarsson B, Carmont MR, Brorsson A, Karlsson J, Nilsson Helander K. Endoscopically assisted reconstruction of chronic Achilles tendon ruptures and re-ruptures using a semitendinosus autograft is a viable alternative to pre-existing techniques. Knee Surg Sports Traumatol Arthrosc. 2022 Jul;30(7):2477-2484. doi: 10.1007/s00167-022-06943-2. Epub 2022 Apr 9. PMID 35396938
• Padanilam TG. Chronic Achilles tendon ruptures. Foot Ankle Clin. 2009 Dec;14(4):711-28. doi: 10.1016/j.fcl.2009.08.001. PMID 19857844
• Gabel S, Manoli A 2nd. Neglected rupture of the Achilles tendon. Foot Ankle Int. 1994 Sep;15(9):512-7. doi: 10.1177/107110079401500912. PMID 7820247
• Kraeutler MJ, Purcell JM, Hunt KJ. Chronic Achilles Tendon Ruptures. Foot Ankle Int. 2017 Aug;38(8):921-929. doi: 10.1177/1071100717709570. Epub 2017 May 29. No abstract available. PMID 28553729
• Abraham E, Pankovich AM. Neglected rupture of the Achilles tendon. Treatment by V-Y tendinous flap. J Bone Joint Surg Am. 1975 Mar;57(2):253-5. PMID 1089672
• Kann JN, Myerson MS. Surgical management of chronic ruptures of the Achilles tendon. Foot and ankle clinics. 1997;2(3):535-45.
• Cetti R, Junge J, Vyberg M. Spontaneous rupture of the Achilles tendon is preceded by widespread and bilateral tendon damage and ipsilateral inflammation: a clinical and histopathologic study of 60 patients. Acta Orthop Scand. 2003 Feb;74(1):78-84. doi: 10.1080/00016470310013707. PMID 12635798

Идентификаторы

NCT: NCT06847971 · FHLTT VS GAFHLTT in ATD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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