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NCT Number: NCT06847971

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

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assuit university hospitals

Asyut, Asyut Governorate, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: at 6 months, and 1 year follow up visits

    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

  2. Strength Testing with handheld Dynamometry for plantar flexors

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

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

Secondary outcomes

  1. Rate of complications

    Time frame: Through study completion, an average of 1 year

    wound healing complications, post-operative infections, nerve injuries, and tendon re-rupture.

  2. Foot function index

    Time frame: at 6 months, and 1 year follow up visits

    Foot function index included 17 questions, covering three sub-scales of foot function: Pain, Disability, and Activity Limitation. Scoring for the Foot Function is based on a visual analog scale with 10 intervals. Scores are calculated for each of the sub-scales, as well as a total score (average of all sub-scales). Scores may be represented both as a raw score and a percentage. Higher scores indicate worsening foot health and poorer foot-related quality of life. The score ranges from 0 to 170 with 0 being the best regarding foot function and 170 the worst regarding foot function.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed E. Osman, Assist.prof

CONTACT

[email protected]

+201012756356

Moaiadeldin A. Abelmawla

CONTACT

[email protected]

+201028591904

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 26, 2025
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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