Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06114368

Endoscopic Flexor Hallucis Longus Transfer vs Minimally Invasive Repair in Acute Achilles Tendon Rupture

The goal of this observational study is to compare the outcomes of two different surgical techniques (Endoscopic Flexor Hallucis Longus transfer - Group 1 vs Minimally Invasive primary repair - Group 2) for patients with acute Achilles tendon rupture. The main questions to be answered are:

1. Which group's patients are more satisfied? 2. Which group's patients appear to have a greater complication rate? 3. Which group's patients have greater calf and ankle circumference compared to the unaffected limb? 4. Which group's patients have greater passive and active range of ankle motion compared to the unaffected limb? 5. Are group 1 patients characterized by strength deficit in hallux flexion power?

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital of Naoussa

Náousa, Central Macedonia, 59200, Greece

About this study

Two separate foot and ankle surgeons in Northern Greece prefer to use a different surgical technique in their respective patients with Acute Achilles tendon rupture.

The first one (A.E.) prefers to perform only Endoscopic Flexor Hallucis Longus transfer, while the second one (P.S.) prefers to perform only Minimally invasive primary repair assisted by the Achillon device (Percutaneous Achilles Repair System - PARS). They both agreed to enroll their recently operated patients (last 5 years) in this retrospective study, which will be conducted by the researcher (M.K.). The patient's study may be retrospective, nevertheless, the patients were randomly chosen and enrolled by a prospectively designed study protocol. Each surgeon applied the respective surgical treatment modality regardless of each patient's characteristics, biometrics, or comorbidities. Inclusion and Elimination criteria will be applied. The patient's satisfaction will be evaluated with the Achilles Tendon Total Rupture Score (ATRS). Complications will be documented. Calf and ankle circumference will be measured and compared to the contralateral healthy limb. Ankle passive and active range of motion will be measured and compared to the contralateral healthy limb. Possible correlations will be investigated regarding patient age, BMI, history of smoking, level of activity, and comorbidities.

Who can participate

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

Inclusion criteria

  • Signed Consent Form
  • Age between 18-75 years
  • Acute Achilles Tendon Rupture (<3 weeks)
  • Surgical Management with Endoscopic Flexor Hallucis Longus transfer or Minimally Invasive primary tendon repair
  • More than 12 months postoperative follow-up
  • Patients operated after 2015

Exclusion criteria

  • Inability or Unwillingness to cooperate
  • Medically unfit for examination (e.g. due to terminal illness)
  • Age less than 18 or more than 75 years
  • Non-operative Management as definitive treatment
  • Surgical Management other than the ones described in the inclusion criteria
  • Neglected Achilles Tendon Rupture (>3 weeks)
  • Bilateral Achilles Tendon Rupture
  • Patients operated before 2015
  • 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

Surgery for the treatment of Acute Achilles tendon rupture

Procedure

Two different surgical techniques were applied in two different patient groups for the same disease. Their outcomes are evaluated and compared

Primary outcomes

  1. Patient Satisfaction assessed with the Achilles Tendon Total Rupture Score

    Time frame: More than 12 months postoperatively

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

Secondary outcomes

  1. Complication Rate

    Time frame: More than 12 months postoperatively

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

  2. Calf Circumference

    Time frame: More than 12 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: More than 12 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 joint Range of Motion

    Time frame: More than 12 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
  • Private Orthopedics Practice P. Symeonidis

Registry information

Official study title

Outcomes Evaluation of Endoscopic Flexor Hallucis Longus Transfer Versus Minimally Invasive Primary Repair in Patients With Acute Achilles Tendon Rupture

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 2, 2023
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.

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