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

Not Applicable

Not yet recruiting

• Conditions: Achilles Tendon Repairs/reconstructions; Achilles Tendon Rupture

• Registration Number: NCT06847971
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-22
• Last Update Submitted: 2025-02-22
• Study First Posted: 2025-02-26
• Last Update Posted: 2025-02-26
• Study Start: 2025-06
• Primary Completion: 2028-01
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
American Orthopedic Foot and Ankle Society (AOFAS) Score Ankle-Hindfoot Scale	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
Strength Testing with handheld Dynamometry for plantar flexors	At 3 months, 6 months, and one year follow up visits.	Isometric plantar flexion against consistent resistance with the strength measured in Newtons.

Secondary Outcome Measures

Name	Time	Method
Rate of complications	Through study completion, an average of 1 year	wound healing complications, post-operative infections, nerve injuries, and tendon re-rupture.
Foot function index	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.

Trial Locations

Locations (1)

Assuit university hospitals; 🇪🇬 Assiut, Egypt