Hallux Abductus Valgus and Extensor Hallux Longus; Treatment by MIS Surgery
NCT ID: NCT06243471
Last Updated: 2025-02-17
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
30 participants
OBSERVATIONAL
2024-02-01
2025-02-12
Brief Summary
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The main questions this study aims to answer are:
* How does the hyperextension of the EHL tendon correlate with the presence and severity of HAV?
* What is the effectiveness of MIS surgery in correcting HAV deformities and addressing issues related to EHL tendon hyperextension? Participants in this study will undergo pre-surgical evaluation to assess the severity of HAV and measure the extent of EHL tendon hyperextension using pressure platform analysis and other relevant clinical measures. During the MIS surgery, participants will receive treatment targeted at correcting HAV, possibly involving partial tenotomy.
If there is a comparison group: Researchers will compare individuals who undergo MIS surgery for HAV correction with a control group not receiving this intervention. The comparison aims to assess the effects of MIS surgery on both HAV correction and the relationship between EHL tendon hyperextension and the deformity.
This study endeavors to shed light on the relationship between HAV and EHL tendon hyperextension, the effectiveness of MIS surgery in addressing these issues, and potentially pave the way for improved surgical techniques in treating foot pathologies.
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Detailed Description
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Secondary Objectives:
Compare pre-surgical and post-surgical plantar pressure changes. Determine American Orthopaedic Foot \& Ankle Society Scale (AOFAS scale) values pre-surgery and post-surgery.
Compare the improvement in post-surgical results of angles: HAV, Intermetatarsal Angle (AIM),Proximal Articular Set Angle (PASA),Distal Articular Set Angle(DASA), and the metatarsophalangeal angle of the first ray (lateral projection).
Materials and Methods: The chosen study design is an experimental, controlled, non-randomized, longitudinal, analytical, and prospective study. Subjects meeting the selection criteria will be non-randomly assigned to two different groups: the "Minimally Invasive Surgery Group with Zig-zag EHL Tenotomy" and the "Minimally Invasive Surgery Group without Zig-zag EHL Tenotomy." After surgery, a follow-up with radiological control will be performed, where post-surgical angles will be measured and plantar pressures will be evaluated.
Results: The investigators expect to achieve effective and safe lengthening of the long hallux extensor in all patients with HAV and hyperextension of the first toe.
Conclusions: The study results will indicate that zig-zag tenotomy of the long hallux extensor is a safe, effective, and rapid technique.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group 1
Minimally Invasive Surgery Group with Zigzag EHL Tenotomy
Minimally invasive procedures for the Hallux Abductus Valgus and a zig-zag tenotomy for the extensus hallux longus.
Minimally invasive procedures for the Hallux Abductus Valgus and a zig-zag tenotomy for the extensus hallux longus.
Group 2
Minimally Invasive Surgery Group without Zig-zag EHL Tenotomy
Minimally invasive procedures for the Hallux Abductus Valgus.
Minimally invasive procedures for the Hallux Abductus Valgus
Interventions
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Minimally invasive procedures for the Hallux Abductus Valgus.
Minimally invasive procedures for the Hallux Abductus Valgus
Minimally invasive procedures for the Hallux Abductus Valgus and a zig-zag tenotomy for the extensus hallux longus.
Minimally invasive procedures for the Hallux Abductus Valgus and a zig-zag tenotomy for the extensus hallux longus.
Eligibility Criteria
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Inclusion Criteria
* Moderate and severe Hallux Abductus Valgus.
* Incorrect metatarsal shape of the 2nd, 3rd and 4th rays due to HAV.
* Be between 20 and 90 years old.
* Patients with no osteoarthritis.
Exclusion Criteria
* Pregnant patients.
* Patients with coagulopathies, diabetes or risk disease (ASA lll, ASA lV).
* Patients with high-risk pharmacological treatments.
20 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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Javier Ferrer-Torregrosa, Dr.
Role: STUDY_DIRECTOR
Fundación Universidad Católica de Valencia San Vicente Mártir
Locations
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Levante Salud
Ondara, Alicante, Spain
Countries
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References
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Marijuschkin I, Souza ML, Diaz JLG, Carvalho P. Percutaneous Hallux Valgus: An Algorithm for the Surgical Treatment. Rev Bras Ortop (Sao Paulo). 2021 Aug;56(4):504-512. doi: 10.1055/s-0040-1721367. Epub 2021 Aug 30.
Restuccia G, Lippi A, Sacchetti F, Citarelli C, Casella F, Benifei M. Percutaneous Hallux Valgus Correction: Modified Reverdin-Isham Osteotomy, Preliminary Results. Surg Technol Int. 2017 Dec 22;31:263-266.
Bauer T, Biau D, Lortat-Jacob A, Hardy P. Percutaneous hallux valgus correction using the Reverdin-Isham osteotomy. Orthop Traumatol Surg Res. 2010 Jun;96(4):407-16. doi: 10.1016/j.otsr.2010.01.007. Epub 2010 May 20.
Botezatu I, Marinescu R, Laptoiu D. Minimally invasive-percutaneous surgery - recent developments of the foot surgery techniques. J Med Life. 2015;8 Spec Issue(Spec Issue):87-93.
Maffulli N, Longo UG, Marinozzi A, Denaro V. Hallux valgus: effectiveness and safety of minimally invasive surgery. A systematic review. Br Med Bull. 2011;97:149-67. doi: 10.1093/bmb/ldq027. Epub 2010 Aug 14.
Biz C, Fosser M, Dalmau-Pastor M, Corradin M, Roda MG, Aldegheri R, Ruggieri P. Functional and radiographic outcomes of hallux valgus correction by mini-invasive surgery with Reverdin-Isham and Akin percutaneous osteotomies: a longitudinal prospective study with a 48-month follow-up. J Orthop Surg Res. 2016 Dec 5;11(1):157. doi: 10.1186/s13018-016-0491-x.
Lu J, Zhao H, Liang X, Ma Q. Comparison of Minimally Invasive and Traditionally Open Surgeries in Correction of Hallux Valgus: A Meta-Analysis. J Foot Ankle Surg. 2020 Jul-Aug;59(4):801-806. doi: 10.1053/j.jfas.2019.03.021.
Bia A, Guerra-Pinto F, Pereira BS, Corte-Real N, Oliva XM. Percutaneous Osteotomies in Hallux Valgus: A Systematic Review. J Foot Ankle Surg. 2018 Jan-Feb;57(1):123-130. doi: 10.1053/j.jfas.2017.06.027. Epub 2017 Sep 1.
Other Identifiers
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UCV/2022-2023/035
Identifier Type: -
Identifier Source: org_study_id
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