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NCT Number: NCT07344077

Comparing Outcomes Using 1 Versus 2 Kirshner Wire Fixation in Patients With Severe Hallux Valgus

Comparing the radiographic and functional outcomes by using a Minimal invasive procedure to treat Hallux Valgus ; Distal linear Metatarsal Osteotomy -

1 Kirshner wire fixation versus two Kirshner wire fixation

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This is a randomise controlled trial between two groups patients, which are assigned to two different interventions, undergoing minimal invasive Hallux valgus surgery.

2nd generation of Minimal invasive surgery was selected in hallux valgus surgery due to its availability, cost effectiveness, reduced pain , and the overall simplicity of the operation, providing smaller surgical scars, and less op time , as well as blood loss.

this was done by making a osteotomy cut at the first metatarsal neck and placing one intramedullary Kirshner wire through the first metatarsal joint.

However the stability and the complication of this technique still remains - such as recurrence, K wire loosening, pin tract infection and malunion.

We believe that by adding another intramedullary Kirshner wire to fix the first metatarsal accoss the Metatarsophalangeal joint, the stability of the construct will improve and maintain a reduced hallux valgus angle ,and reduce the rate of complications , ultimately improving pain and functional outcome of the patient.

the participants were purposely randomized, and divided into two equal groups with 25 cases. the control group recieved a fixation with one Kirshner wire (standard) and the experimental group recieved a fixation with two Kirshner wire. Data were analyzed using paired T test , wilcoxon signed-rank test and chi squared test

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age 18-60 year
  • pain along medial surface of first MTP joint
  • radiographic finding : medial deviation of first Metatarsal bone , and lateral deviation of Big toe
  • complete a follow up period of 1 year , filling questionaires and undergone radiographic examination every visit
  • radiographic finding : Hallux valgus angle >20 , Intermetatarsal angle > 10 degrees
  • failed conservative treatment for atleast 8 months , with persistent pain along medial eminence and having difficulty walking, bearing weight

Exclusion criteria

  • previous injury/fracture at big toe
  • deviation/ subluxation of 1st MTP joint from traumatic event
  • arthritic change of metatarsal bone, phalangeal bone of big toe
  • previous/active infection , open wound along first metatarsal and big toe
  • patient denied enrolling in study

Treatment and study plan

2 Kirshner wire fixation

Procedure

additional Kirshner wire fixation of first metatarsal bone

Primary outcomes

  1. Hallux Valgus Angle ( HVA )

    Time frame: baseline, 2 week , 1 month , 2 month, 4 month , 8 month, 12 month

    degree of long axis of first Metatarsal to first proximal phalanx big toe

Study contacts

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

Krit Patana-anake, M.D.

CONTACT

[email protected]

+66849404004

Sponsors and collaborators

Lead sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Other

Registry information

Official study title

Comparison of Radiographic and Functional Outcomes of Minimal Invasive Distal Metatarsal Osteotomy Using 1 Versus 2 Kirshner Wire Fixation in Patients With Severe Hallux Valgus: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

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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