Clinical trial NCT06847971: Flexor Hallucis Longus Tendon Transfer VS Gastrocnemius Augmented Flexor Hallucis Longus Tendon Transfer in Management of Achilles Tendon Defect
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Achilles Tendon Repairs/reconstructions
Achilles Tendon Rupture
Keywords: Achilles tendon rupture
flexor hallucis longus
gastrocnemius augmentation
Achilles tendon repairs/reconstructions
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 72
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: American Orthopedic Foot and Ankle Society (AOFAS) Score Ankle-Hindfoot Scale
timeFrame: at 6 months, and 1 year follow up visits
measure: Strength Testing with handheld Dynamometry for plantar flexors
timeFrame: At 3 months, 6 months, and one year follow up visits.
Secondary outcomes:
measure: Rate of complications
timeFrame: Through study completion, an average of 1 year
measure: Foot function index
timeFrame: at 6 months, and 1 year follow up visits
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit university hospitals
Study officials:
References:
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