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Enrolling by invitation NCT06641401

Endoscopic FHL Transfer for Acute Achilles Tendon Rupture

— Observational Achilles Tendon Rupture Achilles Tendon Injury Achilles Tendon Surgery Flexor Hallucis Longus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic Flexor Hallucis Longus transfer for Acute Achilles tendon rupture.
Who it may be relevant to
Registry conditions: Achilles Tendon Rupture, Achilles Tendon Injury, Achilles Tendon Surgery, Flexor Hallucis Longus. Basic parameters: 18 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure Endoscopic 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

Primary outcome measures

  • Patient Satisfaction [Time frame: At least 24 months postoperatively]
Secondary outcome measures (4)
  • Complication rate [Time frame: At least 24 months postoperatively]
  • Calf Circumference [Time frame: At least 24 months postoperatively]
  • Ankle Circumference [Time frame: At least 24 months postoperatively]
  • Ankle Range of Motion [Time frame: At least 24 months postoperatively]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Greece · 1 center
  • General Hospital of Naousa — Náousa

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. PMID 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. PMID 32527698

Identifiers

NCT: NCT06641401 · 6/14.6.2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗