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

Queen Savang Vadhana Memorial Hospital, Thailand

Status: Enrolling

Conditions: Hallux Valgus Deformity; Hallux Valgus Correction; Hallux Valgus; Minimal Invasive Surgery

Treatments: Procedure: 2 Kirshner wire fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT07344077

044/2568

Details and patient eligibility

About

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

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

fixation with two kirshner wire in DLMO Surgery

Experimental group

Description:

adding another kirshner wire through the osteotomized first metatarsal bone

Treatment:

Procedure: 2 Kirshner wire fixation

fixation with one kirshner wire in DLMO surgery

No Intervention group

Description:

using a standard technique of one kirshner wire fixation at first metatarsal bone