About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Surgical correction of hallux valgus via osteotomy
Procedure/SurgeryA 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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).
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.
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.
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.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: