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Gastrocnemius EquinusEUGLGCNCT06302530

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

A study testing Stayer, Plantar transection and Baumann in people with Gastrocnemius Equinus, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 3 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 90 years
Conditions the study is for
Gastrocnemius Equinus
What is being tested?
Stayer, Plantar transection and Baumann
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
3 sitesSpain
Study dates
15 Mar 2024to 15 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 90 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Spain3 sites
  • Clinica Mayral foot center

    Barcelona, Barcelon, 08029

  • Podologia Avançada

    Granollers, Barcelona, 08401

  • Clinica Pasito a pasito

    Valencia, Valencia, 46008

Other trials in Spain

About this study

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.

Read the 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.

Being tested
Stayer, Plantar transection, Baumann, Gastro-Soleus
Keywords
Gastrocnemius lengthening, Equinus, Contracture correction surgery, ankle range of motion improvement, Orthopedic foot surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • StayerProcedure or surgery

    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.

  • Plantar transectionProcedure or surgery

    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.

  • BaumannProcedure or surgery

    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.

  • Gastro-SoleusProcedure or surgery

    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.

Study groups in NCT06302530
Study groupRoleWhat they receive
Group Strayer:ExperimentalThis 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.
Receives: Procedure: Stayer
Group Plantar transection:ExperimentalThis 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.
Receives: Procedure: Plantar transection
Group BahumanExperimentalThis 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
Receives: Procedure: Baumann
Group Gastro-SoleusExperimentalThis 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
Receives: Procedure: Gastro-Soleus

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)
  1. Visual Analog Scale.

    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.

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

  2. American Orthopedic Foot and Ankle Score

    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.

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

  3. Complications

    Record of complications related to surgery.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2024
  2. Study start15 Mar 2024
  3. Primary completion30 Dec 2024
  4. Study completion15 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06302530
Sponsor's protocol ID
UCV/2022-2023/155
Acronym
EUGLGC
Status last verified
Apr 2024
First submitted
12 Feb 2024
Last updated
20 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25937405
  • 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.

    PubMed 12063330
  • 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.

    PubMed 25456715
  • 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.

    PubMed 15111077
  • 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.

    PubMed 15428491
  • 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.

    PubMed 36096902
  • 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.

    PubMed 30847522
  • 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.

    PubMed 32705404

Questions about this trial

What is this clinical trial studying?

A study testing Stayer, Plantar transection and Baumann in people with Gastrocnemius Equinus, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ankle range of motion (time frame: Pre-surgery, 2 months, 6months and 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06302530, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.

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