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Recruiting NCT07344077

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

No phase Interventional Hallux Valgus Correction Hallux Valgus Hallux Valgus Deformity Minimal Invasive Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 2 Kirshner wire fixation.
Who it may be relevant to
Registry conditions: Hallux Valgus Correction, Hallux Valgus, Hallux Valgus Deformity, Minimal Invasive Surgery. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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

Detailed description

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

Interventions

  • Procedure 2 Kirshner wire fixation
    additional Kirshner wire fixation of first metatarsal bone

Primary outcome measures

  • Hallux Valgus Angle ( HVA ) [Time frame: baseline, 2 week , 1 month , 2 month, 4 month , 8 month, 12 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Thailand · 1 center
  • Queen Savang Vadhana Memorial hospital — Chon Buri

Identifiers

NCT: NCT07344077 · 044/2568

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗