Change in Shoe Size and Forefoot Morphological Parameters After Scarf + P1 Osteotomy for Hallux Valgus: a Prospective Study Using Surface 3D Scanning (POINTURE-HV)
24 augusti 2026 uppdaterad av: Groupe Hospitalier Diaconesses Croix Saint-Simon
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.
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Younes KERROUMI, Clinical Research Physician
- Telefonnummer: +33144643384
- E-post: ykerroumi@hopital-dcss.org
Studera Kontakt Backup
- Namn: Meriem BAKHTI, Clinical Research Technician
- Telefonnummer: +33144641603
- E-post: mbakhti@hopital-dcss.org
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Hallux valgus
patients consulting for hallux valgus
|
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:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Weight-Bearing 3D Surface Scan Shoe Size at 6 Months Postoperatively
Tidsram: 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.
|
Baseline (preoperative) and 6 months postoperatively
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Self-Reported Shoe Size
Tidsram: Baseline (preoperative) and 6 months postoperatively
|
Difference between the patient's self-reported shoe size at 6 months postoperatively compared to baseline (measured in Paris points).
|
Baseline (preoperative) and 6 months postoperatively
|
|
Correlation Coefficient Between Radiographic and 3D Surface Scanner Angular Measurements
Tidsram: Baseline (preoperative) and 6 months postoperatively
|
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.
|
Baseline (preoperative) and 6 months postoperatively
|
|
Incidence of Surgical Complications
Tidsram: Through 6 months postoperatively
|
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.
|
Through 6 months postoperatively
|
|
Forefoot Morphometric Changes Measured by 3D Surface Scanner
Tidsram: Baseline (preoperative), 6 weeks, and 6 months postoperatively
|
Changes in forefoot width (in mm), metatarsal perimeter (in mm), and global forefoot volume (in cm3) measured during weight-bearing 3D surface scanning.
|
Baseline (preoperative), 6 weeks, and 6 months postoperatively
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Antoine MOUTON, Diaconesses Croix Saint Simon Hospital Group
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
20 september 2026
Primärt slutförande (Beräknad)
20 september 2027
Avslutad studie (Beräknad)
31 december 2027
Studieregistreringsdatum
Först inskickad
5 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
5 augusti 2026
Första postat (Faktisk)
10 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ID RCB/ 2026-A00408-43
Plan för individuella deltagardata (IPD)
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NEJ
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