Hallux ValgusPOINTURE-HVNCT07755488
Change in Shoe Size and Forefoot Morphological Parameters After Scarf + P1 Osteotomy for Hallux Valgus: a Prospective Study Using Surface 3D Scanning
A study testing Surgical correction of hallux valgus via osteotomy in people with Hallux Valgus, run by Groupe Hospitalier Diaconesses Croix Saint-Simon.
Trial summary
Background and Rationale: Surgical correction of Hallux Valgus via Scarf and P1 osteotomy aims to realign the first ray, modifying overall forefoot morphology. While radiological correction is well established, a discrepancy often exists between objective foot measurements and patient-perceived postoperative shoe… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Surgical correction of hallux valgus via osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 31 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient informed about the study and signed written consent obtained in duplicate
- Male or female participant aged 18 years or older
- Symptomatic hallux valgus without lateral ray involvement, requiring surgical correction by Scarf + P1 osteotomy
- Primary surgery planned for the affected foot
- Ability to understand study information, complete questionnaires, and comply with follow-up visits (6 weeks and 6 months)
Who cannot join
- Previous bony surgery of the first ray or forefoot on the affected side (osteotomy, arthrodesis)
- Surgical indication on lateral rays (claw toes, Weil osteotomy)
- Severe lower-limb neurological or vascular disease altering gait or foot morphology (Charcot foot, critical limb ischemia, severe neuropathy)
- Active inflammatory rheumatic disease (e.g., rheumatoid arthritis) with polyarticular foot involvement
- Complex foot deformity requiring primary first metatarsophalangeal (MTP1) arthrodesis or procedure other than Scarf + P1 osteotomy
- Pregnant or breastfeeding woman
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- Person under legal guardianship or unable to provide free and informed consent
- Person deprived of liberty by judicial or administrative decision
- Concurrent participation in another research study that could interfere with study endpoints
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Changes in Shoe Size and Forefoot Morphological Parameters After Scarf + P1 Osteotomy for Hallux Valgus: A Prospective Study Using Surface 3D Scanning
Background and Rationale:
Surgical correction of Hallux Valgus via Scarf and P1 osteotomy aims to realign the first ray, modifying overall forefoot morphology. While radiological correction is well established, a discrepancy often exists between objective foot measurements and patient-perceived postoperative shoe fitting. Weight-bearing 3D surface scanning provides a non-irradiating, precise method to evaluate volumetric and dimensional changes without the biases of traditional foot-measuring gauges.
Read more
Objective and Hypothesis:
The primary objective is to measure changes in shoe size (in French/Paris points) using weight-bearing 3D surface scanning between baseline and 6 months postoperatively. The study hypothesis is that Scarf + P1 osteotomy induces a shoe size reduction of at least 0.5 Paris points at 6 months, correlated with forefoot width reduction, M1 shortening, and angular correction (HVA and M1-M2 angles).
Study Design:
Prospective, single-center, non-comparative interventional study with minimal risks and constraints (RIPH 2) involving 100 participants.
Read the detailed description
Study Procedures and Follow-up Schedule: Preoperative Assessment: Clinical evaluation, standing plain radiographs (HVA and M1-M2 angles), baseline self-reported shoe size, foot-measuring device measurement, and weight-bearing 3D surface scan. Surgical Intervention: Hallux valgus correction via Scarf osteotomy of the first metatarsal combined with P1 phalanx osteotomy. Postoperative Follow-up Visits: 6-Week Visit: Routine clinical evaluation, 3D surface scan, foot-measuring device measurement, and self-reported shoe size assessment. 6-Month Visit: Final follow-up visit including standing radiographs, 3D surface scan, foot-measuring device measurement, self-reported shoe size assessment, and recording of surgical/mechanical complications.
- Conditions
- Hallux Valgus
- Being tested
- Surgical correction of hallux valgus via osteotomy
- Keywords
- Hallux Valgus, Scarf Osteotomy, 3D Surface Scanner, Shoe Size, Forefoot Morphometry
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical correction of hallux valgus via osteotomyProcedure or surgery
A prospective, non-comparative, single-center interventional study involving human subjects and entailing minimal risk and burden (RIPH2).
The interventions introduced by the research consist of:
- Performing a mini-surface scan during the 6-week postoperative consultation.
- Scheduling the patient for a 6-month consultation.
- Performing a mini-surface scan during the 6-month postoperative consultation.
- Measuring shoe size using a foot-measuring device preoperatively, and tracking both reported and measured (using the device) shoe size postoperatively at 6 weeks and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Hallux valgus | Experimental | patients consulting for hallux valgus Receives: Procedure: Surgical correction of hallux valgus via osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight-Bearing 3D Surface Scan Shoe Size at 6 Months Postoperatively
Mean change in shoe size (expressed in French size points / Paris points) measured objectively using a weight-bearing 3D surface scanner between baseline (preoperative) and 6 months postoperatively. The proportion of patients experiencing a clinically significant shoe size reduction of at least 0.5 Paris points will also be assessed.
Measured: Baseline (preoperative) and 6 months postoperatively
Secondary outcomes (4)
Change in Self-Reported Shoe Size
Difference between the patient's self-reported shoe size at 6 months postoperatively compared to baseline (measured in Paris points).
Measured: Baseline (preoperative) and 6 months postoperatively
Forefoot Morphometric Changes Measured by 3D Surface Scanner
Changes in forefoot width (in mm), metatarsal perimeter (in mm), and global forefoot volume (in cm3) measured during weight-bearing 3D surface scanning.
Measured: Baseline (preoperative), 6 weeks, and 6 months postoperatively
Correlation Coefficient Between Radiographic and 3D Surface Scanner Angular Measurements
Correlation coefficient evaluating the agreement between Hallux Valgus Angle (HVA) and Intermetatarsal Angle (M1-M2) measured on standing plain radiographs versus 3D surface scan reconstructions.
Measured: Baseline (preoperative) and 6 months postoperatively
Incidence of Surgical Complications
Proportion of patients experiencing early or late postoperative complications, including deformity recurrence, hallux varus hypercorrection, transfer metatarsalgia, hardware intolerance/failure, delayed wound healing, surgical site infection, or dorsal collateral nerve sensory disorders.
Measured: Through 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start20 Sep 2026 (estimated)
- Primary completion20 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine MOUTON, Principal investigator, Diaconesses Croix Saint Simon Hospital Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755488
- Sponsor's protocol ID
- ID RCB/ 2026-A00408-43
- Acronym
- POINTURE-HV
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Shoe Size and Forefoot Morphological Parameters After Scarf + P1 Osteotomy for Hallux Valgus: A Prospective Study Using Surface 3D Scanning
- ClinicalTrials.gov ID
- NCT07755488
- Acronym / sponsor ID
- POINTURE-HV / ID RCB/ 2026-A00408-43
- Conditions
- Hallux Valgus
- Keywords
- Hallux Valgus, Scarf Osteotomy, 3D Surface Scanner, Shoe Size, Forefoot Morphometry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 20 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Aug 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.
Background and Rationale:
Surgical correction of Hallux Valgus via Scarf and P1 osteotomy aims to realign the first ray, modifying overall forefoot morphology. While radiological correction is well established, a discrepancy often exists between objective foot measurements and patient-perceived postoperative shoe fitting. Weight-bearing 3D surface scanning provides a non-irradiating, precise method to evaluate volumetric and dimensional changes without the biases of traditional foot-measuring gauges.
Objective and Hypothesis:
The primary objective is to measure changes in shoe size (in French/Paris points) using weight-bearing 3D surface scanning between baseline and 6 months postoperatively. The study hypothesis is that Scarf + P1 osteotomy induces a shoe size reduction of at least 0.5 Paris points at 6 months, correlated with forefoot width reduction, M1 shortening, and angular correction (HVA and M1-M2 angles).
Study Design:
Prospective, single-center, non-comparative interventional study with minimal risks and constraints (RIPH 2) involving 100 participants.
Detailed description
Study Procedures and Follow-up Schedule: Preoperative Assessment: Clinical evaluation, standing plain radiographs (HVA and M1-M2 angles), baseline self-reported shoe size, foot-measuring device measurement, and weight-bearing 3D surface scan. Surgical Intervention: Hallux valgus correction via Scarf osteotomy of the first metatarsal combined with P1 phalanx osteotomy. Postoperative Follow-up Visits: 6-Week Visit: Routine clinical evaluation, 3D surface scan, foot-measuring device measurement, and self-reported shoe size assessment. 6-Month Visit: Final follow-up visit including standing radiographs, 3D surface scan, foot-measuring device measurement, self-reported shoe size assessment, and recording of surgical/mechanical complications.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hallux valgus | Experimental | Procedure: Surgical correction of hallux valgus via osteotomypatients consulting for hallux valgus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient informed about the study and signed written consent obtained in duplicate
- Male or female participant aged 18 years or older
- Symptomatic hallux valgus without lateral ray involvement, requiring surgical correction by Scarf + P1 osteotomy
- Primary surgery planned for the affected foot
- Ability to understand study information, complete questionnaires, and comply with follow-up visits (6 weeks and 6 months)
Key exclusion criteria (9 listed)
- Previous bony surgery of the first ray or forefoot on the affected side (osteotomy, arthrodesis)
- Surgical indication on lateral rays (claw toes, Weil osteotomy)
- Severe lower-limb neurological or vascular disease altering gait or foot morphology (Charcot foot, critical limb ischemia, severe neuropathy)
- Active inflammatory rheumatic disease (e.g., rheumatoid arthritis) with polyarticular foot involvement
- Complex foot deformity requiring primary first metatarsophalangeal (MTP1) arthrodesis or procedure other than Scarf + P1 osteotomy
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 |
|---|---|---|
| Surgical correction of hallux valgus via osteotomyA prospective, non-comparative, single-center interventional study involving human subjects and entailing minimal risk and burden (RIPH2). The interventions introduced by the research consist of: 1. Performing a mini-surface scan during the 6-week postoperative consultation. 2. Scheduling the patient for a 6-month consultation. 3. Performing a mini-surface scan during the 6-month postoperative consultation. 4. Measuring shoe size using a foot-measuring device preoperatively, and tracking both reported and measured (using the device) shoe size postoperatively at 6 weeks and 6 months. | Procedure or surgery | Hallux valgus |
Primary outcome
Change in Weight-Bearing 3D Surface Scan Shoe Size at 6 Months Postoperatively
Time frame: Baseline (preoperative) and 6 months postoperatively
Mean change in shoe size (expressed in French size points / Paris points) measured objectively using a weight-bearing 3D surface scanner between baseline (preoperative) and 6 months postoperatively. The proportion of patients experiencing a clinically significant shoe size reduction of at least 0.5 Paris points will also be assessed.
4 secondary outcomes
Change in Self-Reported Shoe Size
Time frame: Baseline (preoperative) and 6 months postoperatively
Forefoot Morphometric Changes Measured by 3D Surface Scanner
Time frame: Baseline (preoperative), 6 weeks, and 6 months postoperatively
Correlation Coefficient Between Radiographic and 3D Surface Scanner Angular Measurements
Time frame: Baseline (preoperative) and 6 months postoperatively
Incidence of Surgical Complications
Time frame: Through 6 months postoperatively
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 26 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Antoine MOUTON principal investigator
Diaconesses Croix Saint Simon Hospital Group
Questions about this trial
What is this clinical trial studying?
A study testing Surgical correction of hallux valgus via osteotomy in people with Hallux Valgus, run by Groupe Hospitalier Diaconesses Croix Saint-Simon.
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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Younes KERROUMI, Clinical Research Physician (+33144643384, ykerroumi@hopital-dcss.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight-Bearing 3D Surface Scan Shoe Size at 6 Months Postoperatively (time frame: Baseline (preoperative) and 6 months postoperatively). 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 26 Aug 2026.