Clinical trial NCT04145882: Efficacy of Additional Osteotomies to Correct Hallux Valgus
Official title: Is it Better to Add Supination Osteotomy, Varisation Osteotomy, or Both to Distal Chevron as Part of Hallux Valgus Management : a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hallux Valgus
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of patients having both Hallux Valgus Angle >15° and InterMetatarsal Angle >10°
timeFrame: 6 months
Secondary outcomes:
measure: Recurrence of hallux valgus (HVA>20°).
timeFrame: 5 years
measure: American Orthopedic Foot and Ankle Forefoot Score (AOFAS)
timeFrame: 6 months
measure: American Orthopedic Foot and Ankle Forefoot Score (AOFAS)
timeFrame: 5 years
measure: Patient satisfaction (Likert scale)
timeFrame: 6 months
measure: Patient satisfaction (Likert scale)
timeFrame: 5 years
Other outcomes:
Locations:
city: Lesquin
country: France
facility: Clinique Lille sud
city: Lyon
country: France
facility: Clinique du Parc Lyon
city: Saint-Aubin-sur-Scie
country: France
facility: Clinique Mégival
city: Saint-Jean
country: France
facility: Clinique de l'Union
Study officials:
References: