An interventional study of Surgical correction of hallux valgus via osteotomy in Hallux Valgus, sponsored by Groupe Hospitalier Diaconesses Croix Saint-Simon. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Groupe Hospitalier Diaconesses Croix Saint-Simon · Not applicable, Interventional, and Health services research
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.
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.
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
This study's planned enrollment of 100 is above the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Groupe Hospitalier Diaconesses Croix Saint-Simon is the lead sponsor of 27 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients consulting for hallux valgus
Procedure: Surgical correction of hallux valgus via osteotomy
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: 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.
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.
Time frame: Baseline (preoperative) and 6 months postoperatively
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through 6 months postoperatively
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's planned 12 months is below that.
Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Groupe Hospitalier Diaconesses Croix Saint-Simon