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

Last updated: February 18, 2025
Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Plantar transection

Baumann

Gastro-Soleus

Clinical Study ID

NCT06302530
UCV/2022-2023/155
  • Ages 10-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 118
Treatment Group(s): 4
Primary Treatment: Plantar transection
Phase:
Study Start date:
March 15, 2024
Estimated Completion Date:
January 15, 2025

Study 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.

Connect with a study center

  • Clinica Mayral foot center

    Barcelona, Barcelon 08029
    Spain

    Site Not Available

  • Podologia Avançada

    Granollers, Barcelona 08401
    Spain

    Site Not Available

  • Clinica Pasito a pasito

    Valencia, 46008
    Spain

    Site Not Available

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