Endoscopic FHL Transfer for Acute Achilles Tendon Rupture

NCT06641401 | Enrolling By Invitation

• 1 other identifier: 6/14.6.2022
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Achilles tendon, rupture, endoscopic, flexor hallucis longus transfer

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction

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

  At least 24 months postoperatively

Secondary Outcomes (4)

• Complication rate

  At least 24 months postoperatively

• Calf Circumference

  At least 24 months postoperatively

• Ankle Circumference

  At least 24 months postoperatively

• Ankle Range of Motion

  At least 24 months postoperatively

Study Arms (1)

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

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

Endoscopic Flexor Hallucis Longus Transfer Group

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• General Hospital of Naoussa: collaborator

Study Sites (1)

General Hospital of Naousa

Náousa, Central Macedonia, 59200, Greece

Location

Related Publications (2)

• 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 BACKGROUND

• 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 RESULT

MeSH Terms

Conditions

Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Michail Kotsapas, MD, MSc

  General Hospital of Naousa, Department of Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Michail Kotsapas, MD, MSc, Resident of Orthopedics (General Hospital of Naoussa), PhD Candidate (Aristotle University of Thessaloniki)

Study Record Dates

• First Submitted: October 12, 2024
• First Posted: October 15, 2024
• Study Start: March 5, 2023
• Primary Completion: January 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

GR (1)