"Effectiveness of the Ultrasound - Guided Lengthening of the Gastrocsoleus Complex"
- Conditions
- Gastrocnemius Equinus
- Interventions
- Procedure: StayerProcedure: Plantar transection
- Registration Number
- NCT06302530
- Lead Sponsor
- Fundación Universidad Católica de Valencia San Vicente Mártir
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A (Strayer): Stayer 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. Group B (Plantar transection): 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.
- Primary Outcome Measures
Name Time Method Ankle range of motion 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 Outcome Measures
Name Time Method American Orthopedic Foot and Ankle Score 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.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.
Complications Pre-surgery,2 months,6months and 1 year. Record of complications related to surgery.
Trial Locations
- Locations (3)
Podologia Avançada
🇪🇸Granollers, Barcelona, Spain
Clinica Mayral foot center
🇪🇸Barcelona, Barcelon, Spain
Clinica Pasito a pasito
🇪🇸Valencia, Spain