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

NCT06847971 | Not Yet Recruiting

• 1 other identifier: FHLTT VS GAFHLTT in ATD
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Achilles Tendon Repairs/reconstructions; Achilles Tendon Rupture

Keywords

Achilles tendon rupture; flexor hallucis longus; gastrocnemius augmentation; Achilles tendon repairs/reconstructions

Outcome Measures

Primary Outcomes (2)

• American Orthopedic Foot and Ankle Society (AOFAS) Score Ankle-Hindfoot Scale

  A scale for assessing the functional status of the ankle and hindfoot. It evaluates both subjective and objective components, including pain, function, alignment, and range of motion. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion. Scores range from 0 to 100, and interpreted as: Excellent: 90-100 Good: 80-89 Fair: 70-79 Poor: ≤69

  at 6 months, and 1 year follow up visits

• Strength Testing with handheld Dynamometry for plantar flexors

  Isometric plantar flexion against consistent resistance with the strength measured in Newtons.

  At 3 months, 6 months, and one year follow up visits.

Secondary Outcomes (2)

• Rate of complications

  Through study completion, an average of 1 year

• Foot function index

  at 6 months, and 1 year follow up visits

Study Arms (2)

Flexor hallucis longus tendon transfer

ACTIVE COMPARATOR

Achilles tendon defects repair will be done by flexor hallucis longus tendon transfer only.

Procedure: Flexor hallucis longus tendon transfer

Gastrocnemius augmented flexor hallucis longus tendon transfer

ACTIVE COMPARATOR

Achilles tendon defect repair by gastrocnemius augmentation plus flexor hallucis longus tendon transfer

Procedure: Gastrocnemius augmented Flexor hallucis longus tendon transfer

Interventions

Flexor hallucis longus tendon transfer PROCEDURE

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. A tunnel will be drilled over the guide wire according to the tendon thickness, without penetrating the planter surface of the calcaneum. The threads at the end of FHL tendon suture will be passed through the eyelet of the guide wire. The tendon will be driven into the calcaneal bony tunnel by pulling the guide wire through the plantar aspect of the heel. Then the FHL tendon will be tenodesed into the bone tunnel using a interference screw of the same size or 1 mm larger than the bone tunnel.

Flexor hallucis longus tendon transfer

Gastrocnemius augmented Flexor hallucis longus tendon transfer PROCEDURE

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 fixation to the calcaneus. V-Y flap will be achieved by having inverted V-shaped incision in the distal part of the gastrocnemius starting proximally and extending the two limbs distally leaving the lateral 1 cm from the original tendon. Then carful advancement of the proximal AT stump distally to reach the calcaneal tuberosity. then Fixation will be achieved by suture anchors. If more than 5 cm gap, tenomyodesis of FHL through the proximal stump of Gastrocnemius muscle will be done.

Gastrocnemius augmented flexor hallucis longus tendon transfer

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit university hospitals

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (12)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Kann JN, Myerson MS. Surgical management of chronic ruptures of the Achilles tendon. Foot and ankle clinics. 1997;2(3):535-45.

  BACKGROUND

• 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 BACKGROUND

• Leslie HD, Edwards WH. Neglected ruptures of the Achilles tendon. Foot Ankle Clin. 2005 Jun;10(2):357-70. doi: 10.1016/j.fcl.2005.01.009.

  PMID: 15922924 BACKGROUND

• Abubeih H, Khaled M, Saleh WR, Said GZ. Flexor hallucis longus transfer clinical outcome through a single incision for chronic Achilles tendon rupture. Int Orthop. 2018 Nov;42(11):2699-2704. doi: 10.1007/s00264-018-3976-x. Epub 2018 May 12.

  PMID: 29754186 BACKGROUND

• Maffulli N, Waterston SW, Squair J, Reaper J, Douglas AS. Changing incidence of Achilles tendon rupture in Scotland: a 15-year study. Clin J Sport Med. 1999 Jul;9(3):157-60. doi: 10.1097/00042752-199907000-00007.

  PMID: 10512344 BACKGROUND

• Leppilahti J, Puranen J, Orava S. Incidence of Achilles tendon rupture. Acta Orthop Scand. 1996 Jun;67(3):277-9. doi: 10.3109/17453679608994688.

  PMID: 8686468 BACKGROUND

Central Study Contacts

Moaiadeldin A. Abelmawla

CONTACT

+201028591904; moaied.16285824@med.aun.edu.eg

Ahmed E. Osman, Assist.prof

CONTACT

+201012756356; ahmed.osman@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 26, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

EG (1)