"Effectiveness of the Ultrasound - Guided Lengthening of the Gastrocsoleus Complex" (EUGLGC)

April 22, 2024 updated by: Fundación Universidad Católica de Valencia San Vicente Mártir
This research project compares the effectiveness of different surgical techniques for lengthening the gastrocnemius-soleus system in patients with equinus deformity. The study will compare 2 techniques: gastrocnemius tendon recession (Strayer) and plantaris resection. Increased ankle range of motion, complications, operative time, recovery time, pain scales and function will be measured. The results will help determine which technique is most effective and safe for correcting equinus deformity.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Equinus deformity is a common deformity caused by contracture of the triceps suralis, especially the gastrocnemius. This causes limitation of ankle dorsiflexion, pain and gait incompetence. Treatment includes surgical lengthening techniques such as gastrocnemius tendon recession (Strayer) or isolated plantar tendon transection.

The minimally invasive Strayer technique is effective but carries morbidity. Ultrasound-guided plantar tendon transection is a new minimally invasive technique but its effectiveness has not been well established.

The aim of this study is to compare the efficacy and safety of the Strayer technique versus isolated plantar tendon transection in the surgical treatment of the equinus deformity. The results will help determine the best surgical option for increasing ankle range of motion in these patients.

To compare the effectiveness of the Strayer technique (gastrocnemius tendon recession) versus plantar tendon transection in patients with equinus deformity

Patients will be divided into two groups:

Group 1: Patients with isolated gastrocnemius contracture undergoing Strayer technique. This consists of ultrasound-guided recession of the gastrocnemius tendon distally.

Group 2: Patients with mild contracture undergoing ultrasound-guided plantar tendon transection of the medial aspect of the gastrocnemius.

The main variables will be the increase in the range of mobility of the ankle, measured with a goniometer before and after surgery. Pain will also be evaluated with visual analogue scale, function with American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score scale, complications and surgical time.

Descriptive statistics, paired Student's t-test for before/after and Student's t-test for independent samples between groups will be used.

The objective is to determine which technique allows a greater increase in ankle range of motion in patients with equinus deformity in a safe and effective manner. The results will help to establish the best surgical option for patients with gastrocnemius contracture.

The study complies with ethical requirements and has the approval of the ethics committee of the Catholic University of Valencia.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Valencia, Spain, 46008
        • Recruiting
        • Clinica Pasito a pasito
        • Contact:
        • Contact:
        • Principal Investigator:
          • JAVIER Ferrer- TORREGROSA, Dr
    • Barcelon
      • Barcelona, Barcelon, Spain, 08029
        • Recruiting
        • Clinica Mayral foot center
        • Principal Investigator:
          • Cristina Razzano
        • Sub-Investigator:
          • Simone Moroni
        • Contact:
        • Sub-Investigator:
          • Jordi Mayral
    • Barcelona
      • Granollers, Barcelona, Spain, 08401
        • Recruiting
        • Podologia Avançada
        • Contact:
        • Sub-Investigator:
          • Lluis Castillo, Dr
        • Principal Investigator:
          • Cristina Razzano
        • Sub-Investigator:
          • Simone Moroni

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical and radiological diagnosis of clubfoot.
  • Limitation of passive dorsiflexion of the ankle (<10°).
  • Associated pain and functional limitation
  • Absence of previous ankle/foot surgeries

Exclusion criteria:

  • Neurologic or congenital disease.
  • Advanced ankle joint osteoarthritis
  • Peripheral vascular insufficiency
  • Uncontrolled diabetes mellitus
  • Severe hepatic or renal disease
  • Coagulopathies or anticoagulant therapy

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (Strayer):
This group will consist of patients with isolated gastrocnemius contracture who will be operated with the Strayer technique. This consists of ultrasound-guided surgical recession of the gastrocnemius tendon distally.
Procedure: Stayer

In group A, the intervention involves using the Strayer technique, an echo-guided recession of the gastrocnemius tendon, with local anesthesia and sedation as needed. The patient can be in a prone or supine position. Ultrasound will identify the sural nerve and blood vessels to prevent damage. The entry point is 2-3 cm distal to the medial head of the gastrocnemius. Local anesthetic is infiltrated, and blunt dissection creates a working space. V-shaped curettes widen the entry point without harming noble structures.

Under direct ultrasound control, a curved scalpel is inserted until reaching the medial border of the gastrocnemius tendon. Transection occurs progressively from medial to lateral while flexing the foot. Verification of complete tendon transection is done with a blunt dissector. Finally, a dressing with adhesive strips and an elastic bandage is applied, eliminating the need for sutures.
Experimental: Group B (Plantar transection):
This group will include patients with mild contracture of the triceps suralis who will undergo surgery by ultrasound-guided transection of the plantar tendon on the medial aspect of the gastrocnemius.
Procedure: Plantar transection
In group B, an echo-guided transection of the plantar tendon will be performed. Local anesthesia and sedation will be used as needed. The patient will be in prone or supine position. The plantar tendon will be identified ultrasonographically on the medial aspect of the gastrocnemius distal to the myotendinous junction. Local anesthetic will be infiltrated at that point to isolate the plantar tendon. An ultrasound-guided retrograde hook is introduced until the plantar tendon is engaged. Then proceed to retrograde transection of the tendon from lateral to medial, verifying complete section. At the end, a dressing with adhesive strips and elastic bandage, without sutures, will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle range of motion
Time Frame: Pre-surgery, 2 months, 6months and 1 year.
Measurement in degrees of the passive dorsiflexion range of the ankle using a goniometer, with the patient in supine position and knee extended.
Pre-surgery, 2 months, 6months and 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale.
Time Frame: Pre-surgery,2 months,6months and 1 year.
This is a measurement tool used to evaluate the intensity of symptoms such as pain, where the patient marks on a visual line the perceived intensity, being 0 no pain and 10 a lot of pain.
Pre-surgery,2 months,6months and 1 year.
American Orthopedic Foot and Ankle Score
Time Frame: Pre-surgery,2 months,6months and 1 year.

The AOFAS Ankle-Hindfoot Scale was designed by the American Foot and Ankle Society to provide an international method to assess the clinical status of the ankle and foot.

This questionnaire incorporates subjective and objective factors that are scored using a numerical scale and describe variables of function, alignment and pain. The score ranges from 0 to 100 depending on the degree of limitation of the patient.
Pre-surgery,2 months,6months and 1 year.
Complications
Time Frame: Pre-surgery,2 months,6months and 1 year.
Record of complications related to surgery.
Pre-surgery,2 months,6months and 1 year.

Collaborators and Investigators

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

Sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

Investigators

  • Principal Investigator: SIMONE MORONI, Dr., UNIVERSIDAD CATOLICA DE VALENCIA
  • Study Director: JAVIER FERRER-TORREGROSA, Dr., UNIVERSIDAD CATOLICA DE VALENCIA

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 15, 2024

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

March 15, 2025

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UCV/2022-2023/155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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