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

Fundación Universidad Católica de Valencia San Vicente Mártir

Status: Completed

Conditions: Gastrocnemius Equinus

Treatments: Procedure: Baumann; Procedure: Gastro-Soleus; Procedure: Plantar transection; Procedure: Stayer

Study type: Interventional

Funder types: Other

Identifiers

NCT06302530

UCV/2022-2023/155

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 10 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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118 participants in 4 patient groups

Group Strayer:

Experimental group

Description:

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.

Treatment:

Procedure: Stayer

Group Plantar transection:

Experimental group

Description:

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.

Treatment:

Procedure: Plantar transection

Group Bahuman

Experimental group

Description:

This group will include patients undergoing an ultrasound-guided recession of the anterior gastrocnemius aponeurosis, where the myotendinous junction is accessed 3 cm proximally using saline for hydrodissection, followed by portal enlargement and scalpel introduction to transect the aponeurosis and plantar tendon under ultrasound verification, without requiring sutures, with patients wearing a Walker boot for 4 weeks and adhering to a stretching protocol

Treatment:

Procedure: Baumann

Group Gastro-Soleus

Experimental group

Description:

This group will include patients undergoing a modified Strayer technique involving the soleus. Under local anesthesia and ultrasound guidance, the gastrocnemius aponeurosis and a superficial portion of the soleus tendon will be transected

Treatment:

Procedure: Gastro-Soleus