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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
Led by Queen Savang Vadhana Memorial Hospital, Thailand · Updated on 2026-01-15
50
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two methods of minimal invasive surgery to treat severe Hallux Valgus, a condition affecting the big toe causing pain and deformity. This randomized controlled trial evaluates the outcomes of using either one or two Kirshner wires for fixation during distal linear metatarsal osteotomy. The study aims to understand if adding a second wire improves stability, reduces complications like recurrence and infections, and enhances pain relief and function. Participants are divided into two groups of 25 each. One group receives the standard fixation with one Kirshner wire placed through the first metatarsal bone, while the other group has an additional wire inserted across the metatarsophalangeal joint for extra stability. This second-generation minimal invasive surgery is chosen for its cost-effectiveness, less pain, smaller scars, shorter surgery time, and reduced blood loss. Over a follow-up period of one year, participants will attend regular visits to complete questionnaires and undergo radiographic exams to measure the Hallux Valgus Angle at baseline and multiple time points up to 12 months. Researchers will analyze pain, function, and complications to compare the two fixation methods. The study involves detailed monitoring to assess the effectiveness and safety of the surgical techniques.
CONDITIONS
Brief Title
Comparing Outcomes Using 1 Versus 2 Kirshner Wire Fixation in Patients With Severe Hallux Valgus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 60 years
- Pain along the inner side of the first metatarsophalangeal joint
- Radiographic evidence of medial deviation of first metatarsal and lateral deviation of big toe
- Hallux valgus angle greater than 20 degrees and intermetatarsal angle greater than 10 degrees on x-rays
- Failed conservative treatment for at least 8 months with persistent pain and difficulty walking or bearing weight
- Willingness to complete 1 year of follow-up with questionnaires and radiographic exams at each visit
You will not qualify if you...
- Previous injury or fracture to the big toe
- Deviation or subluxation of the first metatarsophalangeal joint caused by trauma
- Arthritic changes in the metatarsal or phalangeal bones of the big toe
- Previous or active infection or open wound along the first metatarsal or big toe
- Patient refusal to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and hospital stay as per routine care
Participants undergo minimal invasive distal metatarsal osteotomy surgery with fixation using either one or two Kirshner wires to treat severe hallux valgus.
1 surgical visit (in-person)
Duration - Up to 12 months
Participants attend follow-up visits to monitor recovery, evaluate fixation stability, and assess pain and functional outcomes.
Visits at 2 weeks, 1 month, 2 months, 4 months, 8 months, and 12 months (in-person)
Trial Site Locations
Total: 1 location
1
Queen Savang Vadhana Memorial hospital
Chon Buri, Changwat Chon Buri, Thailand, 20110
Actively Recruiting
Research Team
K
Krit Patana-anake, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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