Endoscopic FHL Transfer for Acute Achilles Tendon Rupture

October 12, 2024 updated by: Michail Kotsapas, Aristotle University Of Thessaloniki

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Central Macedonia
      • Náousa, Central Macedonia, Greece, 59200
        • General Hospital of Naousa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
All patients have already undergone the same operation for the same disease. All data are to be collected retrospectively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: At least 24 months postoperatively
Evaluated and quantified with the Achilles Tendon Total Rupture Score (min = 0 - worst outcome, max = 100 - best outcome)
At least 24 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: At least 24 months postoperatively
Complications will be recorded and categorized: Rerupture, Infection, Nerve injury, Miscellaneous
At least 24 months postoperatively
Calf Circumference
Time Frame: At least 24 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.
At least 24 months postoperatively
Ankle Circumference
Time Frame: At least 24 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.
At least 24 months postoperatively
Ankle Range of Motion
Time Frame: At least 24 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.
At least 24 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Collaborators

General Hospital of Naoussa

Investigators

  • Principal Investigator: Michail Kotsapas, MD, MSc, General Hospital of Naousa, Department of Orthopedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2023

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

October 12, 2024

First Submitted That Met QC Criteria

October 12, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 12, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6/14.6.2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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