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Completed

NCT Number: NCT06302530

"Effectiveness of the Ultrasound - Guided Lengthening of the Gastrocsoleus Complex"

The study analyzes the effectiveness of different ultrasound-guided surgical techniques to treat gastrocnemius contracture and equinus deformity, conditions that affect ankle dorsiflexion and can cause problems such as plantar fasciitis and metatarsalgia. Four techniques were compared: Strayer, Plantaris, Baumann and Gastro-soleo, evaluating their impact on the improvement of ankle motion.

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Key information

Age range

10 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Mayral foot center, Barcelona, Barcelon, Spain

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About this study

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 study will evaluate the effectiveness of four ultrasound-guided surgical techniques in improving ankle dorsiflexion in patients with equinus due to gastrocnemius contracture. The Strayer, Plantaris, Baumann, and Gastro-soleo techniques will be compared, analyzing their impact on mobility before and after surgery.

Patients will be assigned to different groups based on the applied technique, following specific inclusion and exclusion criteria for each procedure. For statistical analysis, Wilcoxon and paired Student's t-tests will be used, depending on data distribution. Additionally, a repeated-measures ANOVA with Tukey's post-hoc tests will be applied to compare the results between techniques and determine which achieves the greatest increase in dorsiflexion range.

All techniques are expected to significantly improve dorsiflexion, with differences in the magnitude of change. The Gastro-soleo technique is anticipated to show the highest absolute increase, while Strayer may be the most statistically effective.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stayer

Procedure

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.

Plantar transection

Procedure

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.

Baumann

Procedure

It consists of an ultrasound-guided recession of the anterior gastrocnemius aponeurosis. Under local anesthesia, the myotendinous junction is accessed 3 cm proximal to the myotendinous junction, using saline for hydrodissection. Under ultrasound guidance, the entry portal is enlarged and a scalpel is introduced for transection of the aponeurosis and plantar tendon. The procedure is verified with a buttoned probe and does not require sutures. The patient wears a Walker boot for 4 weeks and follows a stretching protocol.

Gastro-Soleus

Procedure

This technique adapts the Strayer technique to include the soleus. Under local anesthesia, access is gained 4-5 cm distal to the medial head of the gastrocnemius. Transection of the gastrocnemius aponeurosis and a superficial section of the soleus tendon are performed, all under ultrasound guidance. Without the need for sutures, the patient wears a Walker boot for 4 weeks and follows a progressive rehabilitation protocol.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Complications

    Time frame: Pre-surgery,2 months,6months and 1 year.

    Record of complications related to surgery.

Sponsors and collaborators

Lead sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

Other

Registry information

Acronym: EUGLGC

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 8, 2024
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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