Hallux Valgus CorrectionNCT07344077
Comparing Outcomes Using 1 Versus 2 Kirshner Wire Fixation in Patients With Severe Hallux Valgus
A study testing 2 Kirshner wire fixation in people with Hallux Valgus Correction and Hallux Valgus, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hallux Valgus Correction, Hallux Valgus, Hallux Valgus Deformity
- What is being tested?
- 2 Kirshner wire fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2024to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Queen Savang Vadhana Memorial hospital
Chon Buri, Changwat Chon Buri, 20110
chuenrutai yeekian, Ph.D., +66038322157 ext. 3460, jayeekian88@gmail.com
wanna Sermklin, Bsc, +6638322157 ext. 1182, wannanook04@gmail.com
About this study
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
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
Read the 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
- Conditions
- Hallux Valgus Correction, Hallux Valgus, Hallux Valgus Deformity, Minimal Invasive Surgery
- Being tested
- 2 Kirshner wire fixation
- Keywords
- DLMO, kirshner wire fixation, minimal invasive surgery
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 Kirshner wire fixationProcedure or surgery
additional Kirshner wire fixation of first metatarsal bone
| Study group | Role | What they receive |
|---|---|---|
| fixation with two kirshner wire in DLMO Surgery | Experimental | adding another kirshner wire through the osteotomized first metatarsal bone Receives: Procedure: 2 Kirshner wire fixation |
| fixation with one kirshner wire in DLMO surgery | No intervention | using a standard technique of one kirshner wire fixation at first metatarsal bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hallux Valgus Angle ( HVA )
degree of long axis of first Metatarsal to first proximal phalanx big toe
Measured: baseline, 2 week , 1 month , 2 month, 4 month , 8 month, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jun 2024
- Primary completion1 Jan 2026
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux Valgus CorrectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344077
- Sponsor's protocol ID
- 044/2568
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07344077
- Acronym / sponsor ID
- 044/2568
- Conditions
- Hallux Valgus Correction, Hallux Valgus, Hallux Valgus Deformity, Minimal Invasive Surgery
- Keywords
- DLMO, kirshner wire fixation, minimal invasive surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fixation with two kirshner wire in DLMO Surgery | Experimental | Procedure: 2 Kirshner wire fixationadding another kirshner wire through the osteotomized first metatarsal bone |
| fixation with one kirshner wire in DLMO surgery | No intervention | –using a standard technique of one kirshner wire fixation at first metatarsal bone |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 Kirshner wire fixationadditional Kirshner wire fixation of first metatarsal bone | Procedure or surgery | fixation with two kirshner wire in DLMO Surgery |
Primary outcome
Hallux Valgus Angle ( HVA )
Time frame: baseline, 2 week , 1 month , 2 month, 4 month , 8 month, 12 month
degree of long axis of first Metatarsal to first proximal phalanx big toe
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 Kirshner wire fixation in people with Hallux Valgus Correction and Hallux Valgus, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krit Patana-anake, M.D. (+66849404004, mead.patana@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hallux Valgus Angle ( HVA ) (time frame: baseline, 2 week , 1 month , 2 month, 4 month , 8 month, 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.