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Effectiveness of the Ultrasound - Guided Lengthening of the Gastrocsoleus Complex

Effectiveness of the Ultrasound - Guided Lengthening of the Gastrocsoleus Complex

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06302530
Acronym
EUGLGC
Enrollment
118
Registered
2024-03-08
Start date
2024-03-15
Completion date
2025-01-15
Last updated
2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrocnemius Equinus

Keywords

Gastrocnemius lengthening, Equinus, Contracture correction surgery, ankle range of motion improvement, Orthopedic foot surgery

Brief summary

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.

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 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.

Interventions

PROCEDUREStayer

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.

PROCEDUREPlantar 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.

PROCEDUREBaumann

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.

PROCEDUREGastro-Soleus

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.

Sponsors

Fundación Universidad Católica de Valencia San Vicente Mártir
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

To reduce bias, the study will use double-blind blinding. Patients will not know the group to which they have been assigned. In addition, the assessors performing the ankle range of motion measurements by goniometry will be blinded to each patient's treatment group. Randomization to each group will be performed using opaque sealed envelopes that will be opened in the operating room just prior to surgery. Neither the surgeon nor the patient will know the assignment until that time. The statistical analysis will also be performed in a blinded manner, without the statistician knowing the intervention received by each group. Only after the analysis will the groups be unblinded. In this way, the aim is to reduce the possibility of knowledge of the assigned treatment influencing the evaluation of the results, both on the part of the patients and of the evaluators and analysts.

Eligibility

Sex/Gender
ALL
Age
10 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ankle range of motionPre-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

MeasureTime frameDescription
Visual Analog Scale.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.
American Orthopedic Foot and Ankle ScorePre-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.
ComplicationsPre-surgery,2 months,6months and 1 year.Record of complications related to surgery.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026