Comparing Outcomes Using 1 Versus 2 Kirshner Wire Fixation in Patients With Severe Hallux Valgus
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
1 other identifier
interventional
50
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedFirst Submitted
Initial submission to the registry
January 7, 2026
CompletedFirst Posted
Study publicly available on registry
January 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedJanuary 15, 2026
January 1, 2026
1.6 years
January 7, 2026
January 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hallux Valgus Angle ( HVA )
degree of long axis of first Metatarsal to first proximal phalanx big toe
baseline, 2 week , 1 month , 2 month, 4 month , 8 month, 12 month
Study Arms (2)
fixation with two kirshner wire in DLMO Surgery
EXPERIMENTALadding another kirshner wire through the osteotomized first metatarsal bone
fixation with one kirshner wire in DLMO surgery
NO INTERVENTIONusing a standard technique of one kirshner wire fixation at first metatarsal bone
Interventions
additional Kirshner wire fixation of first metatarsal bone
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Savang Vadhana Memorial hospital
Chon Buri, Changwat Chon Buri, 20110, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2026
First Posted
January 15, 2026
Study Start
June 1, 2024
Primary Completion
January 1, 2026
Study Completion
May 1, 2026
Last Updated
January 15, 2026
Record last verified: 2026-01