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NCT Number: NCT06243471

Hallux Abductus Valgus and Extensor Hallux Longus; 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.

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Key information

Conditions

Hallux Valgus and Bunion Bunion Foot Deformities Foot Deformities, Acquired Hallux Valgus Musculoskeletal Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Levante Salud

Ondara, Alicante, 03760, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Minimally invasive procedures for the Hallux Abductus Valgus.

Procedure

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.

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

Other

Registry information

Official study title

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

Acronym: HAV-EHL-MIS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2024
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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