Endoscopic Flexor Hallucis Longus Transfer vs Minimally Invasive Repair in Acute Achilles Tendon Rupture

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

Outcomes Evaluation of Endoscopic Flexor Hallucis Longus Transfer Versus Minimally Invasive Primary Repair in Patients With Acute Achilles Tendon Rupture

The goal of this observational study is to compare the outcomes of two different surgical techniques (Endoscopic Flexor Hallucis Longus transfer - Group 1 vs Minimally Invasive primary repair - Group 2) for patients with acute Achilles tendon rupture. The main questions to be answered are:

  1. Which group's patients are more satisfied?
  2. Which group's patients appear to have a greater complication rate?
  3. Which group's patients have greater calf and ankle circumference compared to the unaffected limb?
  4. Which group's patients have greater passive and active range of ankle motion compared to the unaffected limb?
  5. Are group 1 patients characterized by strength deficit in hallux flexion power?

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Two separate foot and ankle surgeons in Northern Greece prefer to use a different surgical technique in their respective patients with Acute Achilles tendon rupture.

The first one (A.E.) prefers to perform only Endoscopic Flexor Hallucis Longus transfer, while the second one (P.S.) prefers to perform only Minimally invasive primary repair assisted by the Achillon device (Percutaneous Achilles Repair System - PARS). They both agreed to enroll their recently operated patients (last 5 years) in this retrospective study, which will be conducted by the researcher (M.K.). The patient's study may be retrospective, nevertheless, the patients were randomly chosen and enrolled by a prospectively designed study protocol. Each surgeon applied the respective surgical treatment modality regardless of each patient's characteristics, biometrics, or comorbidities. Inclusion and Elimination criteria will be applied. The patient's satisfaction will be evaluated with the Achilles Tendon Total Rupture Score (ATRS). Complications will be documented. Calf and ankle circumference will be measured and compared to the contralateral healthy limb. Ankle passive and active range of motion will be measured and compared to the contralateral healthy limb. Possible correlations will be investigated regarding patient age, BMI, history of smoking, level of activity, and comorbidities.

Study Type

Observational

Enrollment (Estimated)

40

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 Naoussa

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
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients with Achilles tendon rupture operated exclusively with these two surgical techniques, by these two particular surgeons (A.E. and P.S.) in their respective hospitals (General Hospital of Naoussa, St Luke's Hospital).

Description

Inclusion Criteria:

  • Signed Consent Form
  • Age between 18-75 years
  • Acute Achilles Tendon Rupture (<3 weeks)
  • Surgical Management with Endoscopic Flexor Hallucis Longus transfer or Minimally Invasive primary tendon repair
  • More than 12 months postoperative follow-up
  • Patients operated after 2015

Exclusion Criteria:

  • Inability or Unwillingness to cooperate
  • Medically unfit for examination (e.g. due to terminal illness)
  • Age less than 18 or more than 75 years
  • Non-operative Management as definitive treatment
  • Surgical Management other than the ones described in the inclusion criteria
  • Neglected Achilles Tendon Rupture (>3 weeks)
  • Bilateral Achilles Tendon Rupture
  • Patients operated before 2015
  • 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 1
Patients with acute Achilles tendon rupture managed with Endoscopic Flexor Hallucis Longus transfer by one surgeon (A.E.) in one hospital (General Hospital of Naoussa, Naoussa, Greece), all of which followed the same rehabilitation protocol.
Procedure: Surgery for the treatment of Acute Achilles tendon rupture
Two different surgical techniques were applied in two different patient groups for the same disease. Their outcomes are evaluated and compared
Minimally Invasive Primary repair / Group 2
Patients with acute Achilles tendon rupture managed with Minimally Invasive Primary repair by one surgeon (P.S.) in one hospital (St. Luke's Hospital, Thessaloniki, Greece), all of which followed the same rehabilitation protocol.
Procedure: Surgery for the treatment of Acute Achilles tendon rupture
Two different surgical techniques were applied in two different patient groups for the same disease. Their outcomes are evaluated and compared

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction assessed with the Achilles Tendon Total Rupture Score
Time Frame: More than 12 months postoperatively
Evaluated and quantified with the Achilles Tendon Total Rupture Score (minimum value = 0 - worst outcome, maximal value = 100 - best outcome)
More than 12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calf Circumference
Time Frame: More than 12 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.
More than 12 months postoperatively
Ankle Circumference
Time Frame: More than 12 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.
More than 12 months postoperatively
Ankle joint Range of Motion
Time Frame: More than 12 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.
More than 12 months postoperatively
Complication Rate
Time Frame: More than 12 months postoperatively
Complications will be recorded and categorized: Rerupture, Infection, Nerve injury, Miscellaneous
More than 12 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
Private Orthopedics Practice P. Symeonidis

Investigators

  • Principal Investigator: Michail K. Kotsapas, MD, MSc, Aristotle University of Thessaloniki

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)

March 30, 2025

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

October 28, 2023

First Submitted That Met QC Criteria

October 28, 2023

First Posted (Actual)

November 2, 2023

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

  • 26543

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 respective surgeon (A.E. and P.S.). Thus, 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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