Clinical trial NCT06302530: "Effectiveness of the Ultrasound - Guided Lengthening of the Gastrocsoleus Complex"
Official title: "Effectiveness of the Ultrasound - Guided Lengthening of the Gastrocsoleus Complex"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrocnemius Equinus
Keywords: Gastrocnemius lengthening
Equinus
Contracture correction surgery
ankle range of motion improvement
Orthopedic foot surgery
Lead sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 118
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 criteria:

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

Primary outcomes:
measure: Ankle range of motion
timeFrame: Pre-surgery, 2 months, 6months and 1 year.
Secondary outcomes:
measure: Visual Analog Scale.
timeFrame: Pre-surgery,2 months,6months and 1 year.
measure: American Orthopedic Foot and Ankle Score
timeFrame: Pre-surgery,2 months,6months and 1 year.
measure: Complications
timeFrame: Pre-surgery,2 months,6months and 1 year.
Other outcomes:
Locations:
city: Granollers
country: Spain
facility: Podologia Avançada
state: Barcelona
city: Barcelona
country: Spain
facility: Clinica Mayral foot center
state: Barcelon
city: Valencia
country: Spain
facility: Clinica Pasito a pasito
Study officials:
affiliation: UNIVERSIDAD CATOLICA DE VALENCIA
name: SIMONE MORONI, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: UNIVERSIDAD CATOLICA DE VALENCIA
name: JAVIER FERRER-TORREGROSA, Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.