One versus two Kirschner wires for minimally invasive correction of 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
This trial tests whether adding a second Kirschner (K-) wire during minimally invasive bunion surgery helps people with severe hallux valgus keep their toe alignment and have fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Queen Savang Vadhana Memorial Hospital, Thailand Academic / other |
| Locations | 1 site (Chon Buri, Changwat Chon Buri) |
| Trial ID | NCT07344077 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial comparing outcomes after a distal linear metatarsal osteotomy done by a minimally invasive approach with either one intramedullary K-wire (standard) or two K-wires (experimental). Fifty patients were randomized into two equal groups and followed with radiographs, pain and functional questionnaires, and complication surveillance for one year. Primary measures include hallux valgus and intermetatarsal angles on imaging, plus patient-reported pain and function, and rates of issues such as wire loosening, pin-tract infection, recurrence, and malunion. Data analysis used paired t tests, Wilcoxon signed-rank tests, and chi-squared tests to compare groups over time.
Who should consider this trial
Good fit: Adults 18–60 years with symptomatic hallux valgus (HVA >20°, IMA >10°), medial first MTP pain, and at least eight months of failed conservative care who can complete one-year follow-up are ideal candidates.
Not a fit: Patients with prior big toe fracture or traumatic subluxation, osteoarthritic changes of the first ray, active infection or open wounds, or those who decline enrollment are unlikely to benefit from this procedure within the trial.
Why it matters
Potential benefit: If successful, adding a second K-wire could improve construct stability, reduce recurrence and hardware complications, and lead to less pain and better function after bunion surgery.
How similar studies have performed: Minimally invasive distal metatarsal osteotomy with single K-wire fixation is commonly used and shows good outcomes but has reported instability and hardware complications, while the two-wire modification has been proposed but lacks extensive comparative evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chon Buri, Changwat Chon Buri
- Queen Savang Vadhana Memorial hospital — Chon Buri, Changwat Chon Buri, Thailand (Recruiting)
Study contacts
- Study coordinator: Krit Patana-anake, M.D.
- Email: mead.patana@gmail.com
- Phone: +66849404004
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.