Skip to content

Efficacy of Additional Osteotomies to Correct Hallux Valgus

Is it Better to Add Supination Osteotomy, Varisation Osteotomy, or Both to Distal Chevron as Part of Hallux Valgus Management : a Prospective Randomized Trial

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04145882
Enrollment
515
Registered
2019-10-31
Start date
2019-09-11
Completion date
2026-09-11
Last updated
2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Valgus

Brief summary

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

Interventions

PROCEDUREadditional osteotomies

varisation osteotomy, supination osteotomy or both

Sponsors

Elsan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient older than 18 years. * Informed consent

Exclusion criteria

* Associated lesser metatarsals surgery. * Associated surgery on midfoot, hindfoot or ankle. * Neurologic diseases (Charcot Marie Tooth disease, poliomyelitis, compartment syndrome sequelae) * Clinical or X-ray degenerative signs (Hallux rigidus) or irreducible deformations (MTP1 arthrodesis indications). * Patient who declined the study.

Design outcomes

Primary

MeasureTime frameDescription
Rate of patients having both Hallux Valgus Angle >15° and InterMetatarsal Angle >10°6 monthson weight bearing X-Rays

Secondary

MeasureTime frameDescription
Recurrence of hallux valgus (HVA>20°).5 years
American Orthopedic Foot and Ankle Forefoot Score (AOFAS)6 monthsMini 0 (Worse) - Maxi 100 (Better)
Patient satisfaction (Likert scale)6 monthsvery satisfied/satisfied/fairly satisfied/no satisfied

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026