Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06641401

Endoscopic FHL Transfer for Acute Achilles Tendon Rupture

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

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Achilles Tendon Rupture Achilles Tendon Injury Achilles Tendon Surgery Flexor Hallucis Longus Rupture Wounds and Injuries

Age range

18 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital of Naousa

Náousa, Central Macedonia, 59200, Greece

About this study

This evaluation will be performed by examining the following parameters:

  • Patient satisfaction quantified with the Achilles tendon Total Rupture Score (ATRS). This is the primary outcome.
  • Complication rate
  • Ankle and Calf circumference compared to the contralateral healthy limb.
  • Passive and Active range of ankle motion compared to the contralateral healthy limb.
  • Hallux flexion force compared to the contralateral healthy limb.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Endoscopic Flexor Hallucis Longus transfer for Acute Achilles tendon rupture

Procedure

All patients have already undergone the same operation for the same disease. All data are to be collected retrospectively

Primary outcomes

  1. Patient Satisfaction

    Time frame: At least 24 months postoperatively

    Evaluated and quantified with the Achilles Tendon Total Rupture Score (min = 0 - worst outcome, max = 100 - best outcome)

Secondary outcomes

  1. Complication rate

    Time frame: At least 24 months postoperatively

    Complications will be recorded and categorized: Rerupture, Infection, Nerve injury, Miscellaneous

  2. Calf Circumference

    Time frame: 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.

  3. Ankle Circumference

    Time frame: 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.

  4. Ankle Range of Motion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • General Hospital of Naoussa

Registry information

Official study title

A Case Series of Endoscopic Flexor Hallucis Longus Transfer for Acute Achilles Tendon Rupture.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.