An interventional study of additional osteotomies in Hallux Valgus, sponsored by Elsan. Active, not recruiting at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by Elsan · Not applicable, Interventional, and Treatment
Among 17 studies in Hallux Valgus with a site in France — 3 open to participants now, 5 under way, none of them phase 3. Hallux Valgus · France.
Among the 17 studies in Hallux Valgus with a site in France, this one has the largest enrollment of the 13 interventional ones that give a count, is one of 3 that started in 2019, is one of 13 with no phase, and was the 7th registered.
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
Browse Hallux Valgus studies →3 of the 17 studies in Hallux Valgus with a site in France are open now. Recruiting first, the newest first:
Clinique Saint Jean, France · Sites in France
Ages 18+
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+
GCS Ramsay Santé pour l'Enseignement et la Recherche · Sites in France
Ages 18–85
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 21 Hallux Valgus studies recruiting now, 10 (48%) set no upper age limit and 7 (33%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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17 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2019.
This study's enrollment of 515 is above the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Median enrollment 74 across the 13 interventional studies, 76 across the 4 observational. Of the 12 that completed or were terminated, 2 (17%) have results posted.
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3 of 17 have an industry lead sponsor. The 10 most frequent:
Elsan is the lead sponsor of 68 studies on the registry; 35 are open to participants now.
Elsan has 1 study filed under Hallux Valgus — fewer than ten, so there is no comparison to draw.
2 of the studies in Hallux Valgus with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06680518Clinique Saint Jean, FranceTourniquet Use in Hallux Valgus Surgery | 2026-11 |
| NCT07653828GCS Ramsay Santé pour l'Enseignement et la RechercheEvaluation of the Impact of Self-rehabilitation After Foot Surgery Via a Connected Application | 2026-12 |
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Among the 17 studies in Hallux Valgus with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Deviation of the big toe in valgus at the level of the first metatarsophalangeal joint is called Hallux Valgus. In case of significant pain especially due to a conflict with the shoes, surgery could be indicated. Angle between the first metatarsal (M1) and the first phalangeal (P1) is named Hallux Valgus Angle (HVA). Angle between M1 and the second metatarsal (M2) is named InterMetatarsal Angle (IMA). Angle between M1 distal articular surface and M1 shaft axis in a frontal plane is named Distal Metatarsal Articular Angle (DMAA).
Insufficient surgical correction is a risk factor of recurrence (HVA>20° after surgery). According to Okuda et al in a 67 patients group treated by proximal osteotomies correction, postoperative risk factors of recurrence at 33 month of follow-up are : HVA>40° before the surgery and HVA>15° with an IMA>10° 10 weeks (3-24) after the surgery.
Currently, one of the most common used procedure is a translated (laterally) distal chevron associated with a release of the metatarso-sesamoid suspensory ligament and a Akin procedure on P1. Nevertheless this procedure does not correct deformation in all plans. HVA and IMA are corrected but DMAA and M1 pronation angle are not.
Surgeons can add three different osteotomies in this type of chevron. In the dorsal saw cut a varisation wedge osteotomy is possible , in the plantar saw cut a supination wedge osteotomy is possible, and both are possible. No studies have tried to assess these three possibilities.
The investigators hypothesize that the addition of a varisation and/or a supination wedge osteotomies in a distal chevron decrease risk factors of recurrence at six months of follow-up
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Procedure: additional osteotomies
Procedure: additional osteotomies
Procedure: additional osteotomies
Procedure: additional osteotomies
varisation osteotomy, supination osteotomy or both
Rate of patients having both Hallux Valgus Angle >15° and InterMetatarsal Angle >10°
on weight bearing X-Rays
Time frame: 6 months
Recurrence of hallux valgus (HVA>20°).
Time frame: 5 years
American Orthopedic Foot and Ankle Forefoot Score (AOFAS)
Mini 0 (Worse) - Maxi 100 (Better)
Time frame: 6 months
American Orthopedic Foot and Ankle Forefoot Score (AOFAS)
Mini 0 (Worse) - Maxi 100 (Better)
Time frame: 5 years
Patient satisfaction (Likert scale)
very satisfied/satisfied/fairly satisfied/no satisfied
Time frame: 6 months
Patient satisfaction (Likert scale)
very satisfied/satisfied/fairly satisfied/no satisfied
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2019 to primary completion in Jul 2021, 22 months.
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 22 months is close to 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 active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Elsan