Clinical trial NCT06641401: Endoscopic FHL Transfer for Acute Achilles Tendon Rupture
Official title: A Case Series of Endoscopic Flexor Hallucis Longus Transfer for Acute Achilles Tendon Rupture.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Achilles Tendon Rupture
Achilles Tendon Injury
Achilles Tendon Surgery
Flexor Hallucis Longus
Keywords: Achilles tendon, rupture, endoscopic, flexor hallucis longus transfer
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: General Hospital of Naoussa
First posted: 2024-10-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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)

Primary outcomes:
measure: Patient Satisfaction
timeFrame: At least 24 months postoperatively
Secondary outcomes:
measure: Complication rate
timeFrame: At least 24 months postoperatively
measure: Calf Circumference
timeFrame: At least 24 months postoperatively
measure: Ankle Circumference
timeFrame: At least 24 months postoperatively
measure: Ankle Range of Motion
timeFrame: At least 24 months postoperatively
Other outcomes:
Locations:
city: Náousa
country: Greece
facility: General Hospital of Naousa
state: Central Macedonia
Study officials:
affiliation: General Hospital of Naousa, Department of Orthopedics
name: Michail Kotsapas, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.