One versus two Kirschner wires for minimally invasive correction of severe hallux valgus
Official title: 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
Run by Queen Savang Vadhana Memorial Hospital, Thailand · NCT07344077 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Queen Savang Vadhana Memorial Hospital, Thailand Academic / other |
| Locations | 1 site (Chon Buri, Changwat Chon Buri) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | January 1, 2026 |
| Study ends | May 1, 2026 |
| Registry record updated | January 15, 2026 |
| Trial ID | NCT07344077 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Minimally Invasive Closed Hemorrhoidectomy for Grade III Hemorrhoids
This study tests a minimally invasive, closed hemorrhoidectomy approach for adults with Grade III hemorrhoids to see if it offers good outcomes with less pain and quicker healing.
-
Self-rehabilitation after foot surgery with a connected app
This study tests whether a connected rehabilitation app can help adults after hallux valgus surgery improve ankle and toe mobility at home.
-
Sciatic nerve block with extended-release bupivacaine (ALX006) for bunion surgery
This will test whether a single-dose extended-release bupivacaine (ALX006) given as a sciatic nerve block reduces pain after bunion surgery in adults.
-
VIRTUGUIDE System with DePuy Synthes Lapidus Implant for Hallux Valgus
This study tests how well the VIRTUGUIDE System with a compatible DePuy Synthes Lapidus implant works for people undergoing a primary Lapidus procedure to correct hallux valgus.
-
Custom 3D-printed toe spacer for bunion (hallux valgus) surgery recovery
This will test whether a custom 3D-printed toe spacer is more comfortable and better at keeping the big toe aligned than a standard folded-gauze spacer for adults after hallux valgus surgery.
-
How orthotics and foot exercises change the biomechanics of hallux valgus (bunions)
This project will test whether wearing orthotics or doing foot exercises for 12 weeks can change how the foot and lower limb move in people aged 18–45 with bunions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.