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Enrolling by invitationNCT06641401Updated Oct 15, 2024

Endoscopic FHL Transfer for Acute Achilles Tendon Rupture

An observational study in Achilles Tendon Rupture, Achilles Tendon Injury and Achilles Tendon Surgery, sponsored by Aristotle University Of Thessaloniki. Enrolling by invitation at 1 site in Greece. Open to participants aged 18 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Aristotle University Of Thessaloniki · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
28
Ages
18 Years to 18 Years
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Achilles Tendon Rupture
  • Achilles Tendon Injury
  • Achilles Tendon Surgery
  • Flexor Hallucis Longus

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Keywords

  • Achilles tendon, rupture, endoscopic, flexor hallucis longus transfer
03

In context

Rupture

78 studies on the registry are indexed under Rupture; 17 are open to participants now.

This study's planned enrollment of 28 is below the median of 100 across 31 observational studies indexed under Rupture.

Browse Rupture studies →

Lead sponsor

Aristotle University Of Thessaloniki is the lead sponsor of 282 studies on the registry; 55 are open to participants now.

Browse Aristotle University Of Thessaloniki studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who underwent endoscopic flexor hallucis longus transfer for acute Achilles tendon rupture by a single surgeon in a single hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
28 participants (estimated)
Patient registry
No

Groups and cohorts

  • Endoscopic Flexor Hallucis Longus Transfer Group

    28 Patients with acute Achilles tendon rupture treated with Endoscopic Flexor Hallucis Longus transfer by a single surgeon in a single hospital (General Hospital of Naousa, Greece). All patients followed the same postoperative rehabilitation program.

    Procedure: Endoscopic Flexor Hallucis Longus transfer for Acute Achilles tendon rupture

Interventions

  • ProcedureEndoscopic Flexor Hallucis Longus transfer for Acute Achilles tendon rupture

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

06

What researchers measure

Primary outcomes

  1. Patient Satisfaction

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

    Time frame: At least 24 months postoperatively

Secondary outcomes

  1. Complication rate

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

    Time frame: At least 24 months postoperatively

  2. Calf Circumference

    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.

    Time frame: At least 24 months postoperatively

  3. Ankle Circumference

    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.

    Time frame: At least 24 months postoperatively

  4. Ankle Range of Motion

    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.

    Time frame: At least 24 months postoperatively

07

Study locations

1 site
  • General Hospital of Naousa
    Náousa, Central Macedonia 59200, Greece
08

References and documents

Publications

  • Abdelatif NMN, Batista JP. Endoscopic Flexor Hallucis Longus Transfer for the Management of Acute Achilles Tendon Ruptures in Professional Soccer Players. Foot Ankle Int. 2022 Feb;43(2):164-175. doi: 10.1177/10711007211036439. Epub 2021 Sep 24. PubMed 34558318 ↗
  • Batista JP, Abdelatif NMN, Del Vecchio JJ, Diniz P, Pereira H. Endoscopic Flexor Hallucis Longus Transfer for the Management of Acute Achilles Tendon Ruptures: A Prospective Case Series Report With a Minimum of 18 Months' Follow-Up. J Foot Ankle Surg. 2020 Sep-Oct;59(5):927-937. doi: 10.1053/j.jfas.2019.12.008. Epub 2020 Jun 9. PubMed 32527698 ↗

Individual participant data

Plan to share: Undecided — The records of each patient to be enrolled belong to the General Hospital of Naousa. The records of each patient will be entrusted to the main researcher (M.K.) with the obligation to maintain doctor-patient confidentiality. The final study results will not reveal any sensitive patient data (de-identification). Photos and videos of each patient's examination may be taken after ensuring their written and oral informed consent.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2023 (actual). Primary completion is estimated for Jan 2025, 22 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2024
First posted
Oct 15, 2024
StartActual
Mar 5, 2023
Primary completionEst.
Jan 30, 2025
CompletionEst.
Dec 30, 2025
Last update
Oct 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06641401
Lead sponsor
Aristotle University Of Thessaloniki
Collaborators
General Hospital of Naoussa
Responsible party
Michail Kotsapas (Michail Kotsapas, MD, MSc, Resident of Orthopedics (General Hospital of Naoussa), PhD Candidate (Aristotle University of Thessaloniki), Aristotle University Of Thessaloniki) — Principal investigator
First posted
Oct 15, 2024
Start date
Mar 5, 2023
Primary completion
Jan 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Oct 15, 2024

Study contacts

Michail Kotsapas, MD, MSc
principal investigator · General Hospital of Naousa, Department of Orthopedics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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