Comparing Outcomes Using 1 Versus 2 Kirshner Wire Fixation in Patients With Severe Hallux Valgus
NCT ID: NCT07344077
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-06-01
2026-05-01
Brief Summary
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1 Kirshner wire fixation versus two Kirshner wire fixation
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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fixation with two kirshner wire in DLMO Surgery
adding another kirshner wire through the osteotomized first metatarsal bone
2 Kirshner wire fixation
additional Kirshner wire fixation of first metatarsal bone
fixation with one kirshner wire in DLMO surgery
using a standard technique of one kirshner wire fixation at first metatarsal bone
No interventions assigned to this group
Interventions
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2 Kirshner wire fixation
additional Kirshner wire fixation of first metatarsal bone
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Queen Savang Vadhana Memorial Hospital, Thailand
OTHER
Responsible Party
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Locations
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Queen Savang Vadhana Memorial hospital
Chon Buri, Changwat Chon Buri, Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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044/2568
Identifier Type: -
Identifier Source: org_study_id
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