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

NCT06302530 | Completed

• 1 other identifier: UCV/2022-2023/155
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 3

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.

Conditions

Gastrocnemius Equinus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Ankle range of motion

  Measurement in degrees of the passive dorsiflexion range of the ankle using a goniometer, with the patient in supine position and knee extended.

  Pre-surgery, 2 months, 6months and 1 year.

Secondary Outcomes (3)

• Visual Analog Scale.

  Pre-surgery,2 months,6months and 1 year.

• American Orthopedic Foot and Ankle Score

  Pre-surgery,2 months,6months and 1 year.

• Complications

  Pre-surgery,2 months,6months and 1 year.

Study Arms (4)

Group Strayer:

EXPERIMENTAL

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.

Procedure: Stayer

Group Plantar transection:

EXPERIMENTAL

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.

Procedure: Plantar transection

Group Bahuman

EXPERIMENTAL

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

Procedure: Baumann

Group Gastro-Soleus

EXPERIMENTAL

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

Procedure: Gastro-Soleus

Interventions

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.

Group Strayer:

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.

Group Plantar transection:

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.

Group Bahuman

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.

Group Gastro-Soleus

Eligibility Criteria

• Age: 10 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Neurologic or congenital disease.
• Advanced ankle joint osteoarthritis
• Peripheral vascular insufficiency
• Uncontrolled diabetes mellitus
• Severe hepatic or renal disease
• Coagulopathies or anticoagulant therapy

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead

Study Sites (3)

Podologia Avançada

Granollers, Barcelona, 08401, Spain

Location

Clinica Mayral foot center

Barcelona, Barcelon, 08029, Spain

Location

Clinica Pasito a pasito

Valencia, Valencia, 46008, Spain

Location

Related Publications (8)

• Cychosz CC, Phisitkul P, Belatti DA, Glazebrook MA, DiGiovanni CW. Gastrocnemius recession for foot and ankle conditions in adults: Evidence-based recommendations. Foot Ankle Surg. 2015 Jun;21(2):77-85. doi: 10.1016/j.fas.2015.02.001. Epub 2015 Feb 26.

  PMID: 25937405 BACKGROUND

• DiGiovanni CW, Kuo R, Tejwani N, Price R, Hansen ST Jr, Cziernecki J, Sangeorzan BJ. Isolated gastrocnemius tightness. J Bone Joint Surg Am. 2002 Jun;84(6):962-70. doi: 10.2106/00004623-200206000-00010.

  PMID: 12063330 BACKGROUND

• Barouk P, Barouk LS. Clinical diagnosis of gastrocnemius tightness. Foot Ankle Clin. 2014 Dec;19(4):659-67. doi: 10.1016/j.fcl.2014.08.004. Epub 2014 Sep 26.

  PMID: 25456715 BACKGROUND

• Maluf KS, Mueller MJ, Strube MJ, Engsberg JR, Johnson JE. Tendon Achilles lengthening for the treatment of neuropathic ulcers causes a temporary reduction in forefoot pressure associated with changes in plantar flexor power rather than ankle motion during gait. J Biomech. 2004 Jun;37(6):897-906. doi: 10.1016/j.jbiomech.2003.10.009.

  PMID: 15111077 BACKGROUND

• STRAYER LM Jr. Recession of the gastrocnemius; an operation to relieve spastic contracture of the calf muscles. J Bone Joint Surg Am. 1950 Jul;32-A(3):671-6. No abstract available.

  PMID: 15428491 BACKGROUND

• Kindred KB, Kapsalis AP, Adams WJE, Miller JM, Blacklidge DK, Elliott BG, Hoffman SM. The Role of the Plantaris in Intramuscular Gastrocnemius Equinus Correction. J Foot Ankle Surg. 2023 Mar-Apr;62(2):272-274. doi: 10.1053/j.jfas.2022.07.006. Epub 2022 Jul 30.

  PMID: 36096902 BACKGROUND

• Hickey B, Lee J, Stephen J, Antflick J, Calder J. It is possible to release the plantaris tendon under ultrasound guidance: a technical description of ultrasound guided plantaris tendon release (UPTR) in the treatment of non-insertional Achilles tendinopathy. Knee Surg Sports Traumatol Arthrosc. 2019 Sep;27(9):2858-2862. doi: 10.1007/s00167-019-05451-0. Epub 2019 Mar 7.

  PMID: 30847522 BACKGROUND

• Moroni S, Fernandez-Gibello A, Nieves GC, Montes R, Zwierzina M, Vazquez T, Garcia-Escudero M, Duparc F, Moriggl B, Konschake M. Anatomical basis of a safe mini-invasive technique for lengthening of the anterior gastrocnemius aponeurosis. Surg Radiol Anat. 2021 Jan;43(1):53-61. doi: 10.1007/s00276-020-02536-1. Epub 2020 Jul 23.

  PMID: 32705404 BACKGROUND

Study Officials

• SIMONE MORONI, Dr.

  UNIVERSIDAD CATOLICA DE VALENCIA

  PRINCIPAL INVESTIGATOR

• JAVIER FERRER-TORREGROSA, Dr.

  UNIVERSIDAD CATOLICA DE VALENCIA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: March 8, 2024
• Study Start: March 15, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 15, 2025
• Last Updated: February 20, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)