"Effectiveness of the Ultrasound - Guided Lengthening of the Gastrocsoleus Complex"
NCT ID: NCT06302530
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
118 participants
INTERVENTIONAL
2024-03-15
2025-01-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
Study Groups
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Group Strayer:
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.
Stayer
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 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.
Plantar transection
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 Bahuman
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
Baumann
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 Gastro-Soleus
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
Gastro-Soleus
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.
Interventions
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Stayer
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 transection
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.
Baumann
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-Soleus
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.
Eligibility Criteria
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Inclusion Criteria
* Limitation of passive dorsiflexion of the ankle (\<10°).
* Associated pain and functional limitation
* Absence of previous ankle/foot surgeries
Exclusion Criteria
* Advanced ankle joint osteoarthritis
* Peripheral vascular insufficiency
* Uncontrolled diabetes mellitus
* Severe hepatic or renal disease
* Coagulopathies or anticoagulant therapy
10 Years
90 Years
ALL
No
Sponsors
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Fundación Universidad Católica de Valencia San Vicente Mártir
OTHER
Responsible Party
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Principal Investigators
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SIMONE MORONI, Dr.
Role: PRINCIPAL_INVESTIGATOR
UNIVERSIDAD CATOLICA DE VALENCIA
JAVIER FERRER-TORREGROSA, Dr.
Role: STUDY_DIRECTOR
UNIVERSIDAD CATOLICA DE VALENCIA
Locations
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Podologia Avançada
Granollers, Barcelona, Spain
Clinica Mayral foot center
Barcelona, Barcelon, Spain
Clinica Pasito a pasito
Valencia, Valencia, Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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UCV/2022-2023/155
Identifier Type: -
Identifier Source: org_study_id
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