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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Flexor hallucis longus tendon transfer

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Flexor hallucis longus tendon transferActive comparator 1 intervention
Group B: Gastrocnemius augmented flexor hallucis longus tendon transferActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
at 6 months, and 1 year follow up visits
2

Strength Testing with handheld Dynamometry for plantar flexors

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

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

Secondary outcomes

1

Rate of complications

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

Time frame
Through study completion, an average of 1 year
2

Foot function index

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: