Hallux Abductus Valgus and Extensor Hallux Longus; Treatment by MIS Surgery

NCT06243471 | Completed

• 1 other identifier: UCV/2022-2023/035
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the relationship between Hallux Abductus Valgus (HAV) and the hyperextension of the Extensor Hallucis Longus (EHL) tendon. The study aims to understand the efficacy of MIS surgery in treating foot deformities like HAV and to evaluate the impact of EHL tendon hyperextension on this condition. 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.

Conditions

Hallux Valgus and Bunion

Keywords

minimal incision surgery; Tenotomy; Extensor hallucis longus; Hallux Abducts Valgus

Outcome Measures

Primary Outcomes (1)

• Radiographic

  Flat Panel is a direct digitization radiography system that provides us with the image in two seconds. The investigators will perform dorso-plantar and lateral oblique radiographs of the patients' feet.

  Pre-surgery, 2 months, 6months

Secondary Outcomes (2)

• Pressure platform

  Pre-surgery, 2 months, 6months

• American Orthopedic Foot and Ankle Society

  Pre-surgery, 2 months, 6months

Study Arms (2)

Group 1

Minimally Invasive Surgery Group with Zigzag EHL Tenotomy

Procedure: 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

Procedure: Minimally invasive procedures for the Hallux Abductus Valgus.

Interventions

Minimally invasive procedures for the Hallux Abductus Valgus. PROCEDURE

Minimally invasive procedures for the Hallux Abductus Valgus

Group 2

Minimally invasive procedures for the Hallux Abductus Valgus and a zig-zag tenotomy for the extensus hallux longus. PROCEDURE

Minimally invasive procedures for the Hallux Abductus Valgus and a zig-zag tenotomy for the extensus hallux longus.

Group 1

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population for this project is men and women between 20 and 90 years old with hallux abductus valgus and the first toe in hyperextension on one or both feet. The subjects in the sample will be patients undergoing surgery in private clinics who come for consultation at the time of the study. The method to select the sample is non-probabilistic due to the inclusion of volunteers.

You may qualify if:

• Pain in the metatarsophalangeal joint of the big toe caused by HAV.
• 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.

You may not qualify if:

• Patients who have previously undergone surgery for Hallux Abductus Valgus.
• Pregnant patients.
• Patients with coagulopathies, diabetes or risk disease (ASA lll, ASA lV).
• Patients with high-risk pharmacological treatments.

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead

Study Sites (1)

Levante Salud

Ondara, Alicante, 03760, Spain

Location

Related Publications (9)

• 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.

  PMID: 34483396 BACKGROUND

• 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.

  PMID: 29310149 BACKGROUND

• 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.

  PMID: 20488776 BACKGROUND

• 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.

  PMID: 26361518 BACKGROUND

• 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.

  PMID: 20710024 BACKGROUND

• 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.

  PMID: 27919259 BACKGROUND

• 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.

  PMID: 32600562 BACKGROUND

• 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.

  PMID: 28870735 BACKGROUND

• Sanchis-Soria V, Ferrer-Torregrosa J, Marti-Martinez LM, Carratala-Villarroya G, Vicente-Mampel J, Lorca-Gutierrez R. Multimodal evaluation of partial zig-zag tenotomy of the extensor hallucis longus in minimally invasive hallux valgus surgery: a randomized trial. J Orthop Surg Res. 2025 Nov 28;21(1):3. doi: 10.1186/s13018-025-06456-x.

  PMID: 41316331 DERIVED

MeSH Terms

Conditions

Hallux Valgus; Bunion

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Acquired

Study Officials

• Javier Ferrer-Torregrosa, Dr.

  Fundación Universidad Católica de Valencia San Vicente Mártir

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 6, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 12, 2025
• Last Updated: February 17, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)