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

NCT ID: NCT06847971

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2028-06-30

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.

Detailed Description

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.

Conditions

Achilles Tendon Repairs/reconstructions; Achilles Tendon Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Flexor hallucis longus tendon transfer

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

Group Type: ACTIVE_COMPARATOR

Flexor hallucis longus tendon transfer

Intervention Type: 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.

Gastrocnemius augmented flexor hallucis longus tendon transfer

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

Group Type: ACTIVE_COMPARATOR

Gastrocnemius augmented Flexor hallucis longus tendon transfer

Intervention Type: 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.

Interventions

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. 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.

Intervention Type: PROCEDURE

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 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Moaiadeldin Ahmed Mohamed Ahmed Abdelmawla

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assuit university hospitals

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Central Contacts

Moaiadeldin A. Abelmawla

Role: CONTACT

moaied.16285824@med.aun.edu.eg

+201028591904

Ahmed E. Osman, Assist.prof

Role: CONTACT

ahmed.osman@aun.edu.eg

+201012756356

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

FHLTT VS GAFHLTT in ATD

Identifier Type: -

Identifier Source: org_study_id