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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07344077
Enrollment
50
Registered
2026-01-15
Start date
2024-06-01
Completion date
2026-05-01
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Valgus, Hallux Valgus Correction, Hallux Valgus Deformity, Minimal Invasive Surgery

Keywords

DLMO, kirshner wire fixation, minimal invasive surgery

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

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

PROCEDURE2 Kirshner wire fixation

additional Kirshner wire fixation of first metatarsal bone

Sponsors

Queen Savang Vadhana Memorial Hospital, Thailand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hallux Valgus Angle ( HVA )baseline, 2 week , 1 month , 2 month, 4 month , 8 month, 12 monthdegree of long axis of first Metatarsal to first proximal phalanx big toe

Countries

Thailand

Contacts

Primary ContactKrit Patana-anake, M.D.
mead.patana@gmail.com+66849404004

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026