Hallux Abductus Valgus and Extensor Hallux Longus; Treatment by MIS Surgery (HAV-EHL-MIS)

February 13, 2025 updated by: Fundación Universidad Católica de Valencia San Vicente Mártir

"Hallux Abductus Valgus and Extensor Hallux Longus: Relationship Between Them, Preoperative and Postoperative Assessment, Pressure Platform and Treatment by MIS Surgery"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Main Objective: To analyze the effectiveness of incomplete zig-zag tenotomy of the EHL combined with minimally invasive foot surgery for the correction of moderate and severe hallux abducts valgus (HAV).

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Ondara, Alicante, Spain, 03760
        • Levante Salud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Minimally invasive procedures for the Hallux Abductus Valgus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic
Time Frame: Pre-surgery, 2 months, 6months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure platform
Time Frame: Pre-surgery, 2 months, 6months
It is a tool that allows us to know the distribution of pressures on the sole of the foot, both statically and dynamically. It offers a range of colors in the patient's footprint according to the baropressure captured. It will help us determine the change in pre-surgical and post-surgical plantar pressures.
Pre-surgery, 2 months, 6months
American Orthopedic Foot and Ankle Society
Time Frame: Pre-surgery, 2 months, 6months
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.
Pre-surgery, 2 months, 6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

Investigators

  • Study Director: Javier Ferrer-Torregrosa, Dr., Fundación Universidad Católica de Valencia San Vicente Mártir

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

February 1, 2025

Study Completion (Actual)

February 12, 2025

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 13, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCV/2022-2023/035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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