Efficacy of Additional Osteotomies to Correct Hallux Valgus

Not Applicable

Active, not recruiting

• Conditions: Hallux Valgus
• Interventions: Procedure: additional osteotomies

• Registration Number: NCT04145882
• Lead Sponsor: Elsan

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-11
• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-10-31
• Primary Completion: 2021-07-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29
• Study Completion: 2026-09-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 515

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No additional osteotomy	additional osteotomies	-
supination osteotomy addition	additional osteotomies	-
varisation osteotomy addition	additional osteotomies	-
both (varisation + supination) osteotomies addition.	additional osteotomies	-

Primary Outcome Measures

Name	Time	Method
Rate of patients having both Hallux Valgus Angle >15° and InterMetatarsal Angle >10°	6 months	on weight bearing X-Rays

Secondary Outcome Measures

Name	Time	Method
Recurrence of hallux valgus (HVA>20°).	5 years
American Orthopedic Foot and Ankle Forefoot Score (AOFAS)	5 years	Mini 0 (Worse) - Maxi 100 (Better)
Patient satisfaction (Likert scale)	5 years	very satisfied/satisfied/fairly satisfied/no satisfied

Trial Locations

Locations (4)

Clinique Lille sud; 🇫🇷 Lesquin, France

Clinique du Parc Lyon; 🇫🇷 Lyon, France

Clinique Mégival; 🇫🇷 Saint-Aubin-sur-Scie, France

Clinique de l'Union; 🇫🇷 Saint-Jean, France