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NCT Number: NCT06584487

Proximal Metatarsal Osteotomy in Correction of Hallux Valgus

The outcomes of the correction of hallux valgus by proximal opening wedge osteotomy

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Hallux valgus is a common cause of foot pain and deformity in the adult and adolescent population, which often requires surgical treatment when nonsurgical treatments fail.

During the past decades, multiple modified procedures and fixation techniques have been described.

The most common types of osteotomies of the first metatarsal are crescentic, chevron, scarf and lateral or medial opening wedge techniques.

A concern with the Chevron and other distal osteotomies is the development of avascular necrosis of the first metatarsal head with a reported incidence of between 0% and 20%.

On the other side, the proximal dome osteotomy along with a distal soft tissue release is an excellent procedure. The proximal location of the osteotomy avoids devascularization of the metatarsal head, and the crescent shape maintains the length of the metatarsal. It allows a high degree of correction at the intermetatarsal angle in severe deformities.

When the condition is associated with an increased intermetatarsal angle, a surgical technique using a proximal first metatarsal osteotomy is often indicated. A proximal opening wedge osteotomy stabilized with a wedge and plate configuration offers a stable, reliable means to correct the increased intermetatarsal angle.

Over the past 10 years, some surgeons have increasingly used locking plates instead of a single screw for stabilisation of the osteotomy with the assumption of better postoperative stability and preserved length of the first metatarsal. In addition, fixation with a plate has been described as technically less challenging.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • all admitted patients to Assiut University Hospitals.
  • age group of 15 years old and above.
  • Moderate and severe degrees of hallux valgus.

Exclusion criteria

  • Burn
  • age group below 15 years old.
  • patient who refuse to participate in the study.

Treatment and study plan

Primary outcomes

  1. The American Orthopedic Foot and Ankle Society hallux-metatarsophalangeal-interphalangeal scale (AOFAS scale).

    Time frame: baseline

    Pain-Function-Alignment

Secondary outcomes

  1. Post operative radiographic changes in standing AP view foot and standing lateral view foot.

    Time frame: Baseline

    In standing AP view foot

    • The hallux valgus angle HVA in degrees.It is the angle between long axis of 1st metatarsal and proximal phalanx of big toe
    • The intermetatarsal angle IMA in degree
    • The distal metatarsal articular angle DMAA in degree
    • The 1st metatarsal length in centimeter In standing lateral view foot
    • The inclination angle of the 1st metatarsal in degree In standing AP view foot
    • The hallux valgus angle HVA in degree
    • The intermetatarsal angle IMA in degree
    • The distal metatarsal articular angle DMAA in degree
    • The 1st metatarsal length in centimeter In standing lateral view foot
    • The inclination angle of the 1st metatarsal

Study contacts

Contact information is provided by the study sponsor or research team.

Abdulrahman M Hussein Mohamed, Master

CONTACT

[email protected]

+2001063555610

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Proximal Metatarsal Medial Opening Wedge Osteotomy Fixed by Plate and Screws in Correction of Hallux Valgus

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2024
Registry last updated
Sep 4, 2024

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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