Endoscopic FHL Transfer for Acute Achilles Tendon Rupture

• Conditions: Achilles Tendon Rupture; Achilles Tendon Injury; Achilles Tendon Surgery; Flexor Hallucis Longus

• Registration Number: NCT06641401
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

This observational study aims to evaluate the outcome of endoscopic flexor hallucis longus transfer (FHLt) in patients with acute Achilles tendon rupture (AATR).

Detailed Description

This evaluation will be performed by examining the following parameters:

1. Patient satisfaction quantified with the Achilles tendon Total Rupture Score (ATRS). This is the primary outcome.

2. Complication rate

3. Ankle and Calf circumference compared to the contralateral healthy limb.

4. Passive and Active range of ankle motion compared to the contralateral healthy limb.

5. Hallux flexion force compared to the contralateral healthy limb.

Study Timeline

• Study Start: 2023-03-05
• Status Verified: 2024-10
• Study First Submitted: 2024-10-12
• Study First Submitted QC: 2024-10-12
• Last Update Submitted: 2024-10-12
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-15
• Primary Completion: 2025-01-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Signed Consent Form
• Acute Achilles Tendon Rupture (<4 weeks)
• Underwent operative treatment with Endoscopic Flexor Hallucis Longus transfer
• More than 24 months postoperative follow-up
• Patients operated after 2015

Exclusion Criteria

• Inability or Unwillingness to cooperate
• Medically unfit for examination
• Age less than 18 or more than 75 years
• Non-operative Management or any other Surgical Management
• Neglected Achilles Tendon Rupture (>4 weeks)
• Bilateral Achilles Tendon Rupture
• Patients operated before 1.1.2015 or after 1.1.2023
• Comorbidities interfering with the secondary outcomes (e.g. Venous insufficiency resulting in lower limb excessive edema interferes with ankle and calf circumference, rheumatoid arthritis and/or previous foot and ankle surgery interferes with active and passive range of motion of the ankle, etc)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction	At least 24 months postoperatively	Evaluated and quantified with the Achilles Tendon Total Rupture Score (min = 0 - worst outcome, max = 100 - best outcome)

Secondary Outcome Measures

Name	Time	Method
Complication rate	At least 24 months postoperatively	Complications will be recorded and categorized: Rerupture, Infection, Nerve injury, Miscellaneous
Calf Circumference	At least 24 months postoperatively	Calf circumference measured 15 cm distally to the inferior pole of the patella. Contralateral limb calf circumference will also be measured. The Calf Circumference Difference will be calculated and compared between the two groups.
Ankle Circumference	At least 24 months postoperatively	Ankle circumference measured 8 cm proximally to the lateral malleolus. Contralateral limb ankle circumference will also be measured. The Ankle Circumference Difference will be calculated and compared between the two groups.
Ankle Range of Motion	At least 24 months postoperatively	Active and Passive Ankle joint Range of Motion will be calculated with an electronic goniometer. Contralateral limb Range of Ankle joint Motion will also be measured. The Range of Motion Difference will be calculated and compared between the two groups.

Trial Locations

Locations (1)

General Hospital of Naousa; 🇬🇷 Náousa, Central Macedonia, Greece