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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hallux Valgus
• Intervention / Treatment: Procedure: additional osteotomies

• Study Type: Interventional
• Enrollment (Actual): 515
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lesquin, France, 59810
    • Clinique Lille sud
  • Lyon, France, 69006
    • Clinique du Parc Lyon
  • Saint-Aubin-sur-Scie, France, 76550
    • Clinique Mégival
  • Saint-Jean, France, 31240
    • Clinique de l'Union

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No additional osteotomy	Procedure: additional osteotomies; varisation osteotomy, supination osteotomy or both
Experimental: varisation osteotomy addition	Procedure: additional osteotomies; varisation osteotomy, supination osteotomy or both
Experimental: supination osteotomy addition	Procedure: additional osteotomies; varisation osteotomy, supination osteotomy or both
Experimental: both (varisation + supination) osteotomies addition.	Procedure: additional osteotomies; varisation osteotomy, supination osteotomy or both

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients having both Hallux Valgus Angle >15° and InterMetatarsal Angle >10°	on weight bearing X-Rays	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of hallux valgus (HVA>20°).		5 years
American Orthopedic Foot and Ankle Forefoot Score (AOFAS)	Mini 0 (Worse) - Maxi 100 (Better)	6 months
American Orthopedic Foot and Ankle Forefoot Score (AOFAS)	Mini 0 (Worse) - Maxi 100 (Better)	5 years
Patient satisfaction (Likert scale)	very satisfied/satisfied/fairly satisfied/no satisfied	6 months
Patient satisfaction (Likert scale)	very satisfied/satisfied/fairly satisfied/no satisfied	5 years

Collaborators and Investigators

• Sponsor: Elsan
• Collaborators: Elsan

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2019
• Primary Completion (Actual): July 29, 2021
• Study Completion (Estimated): September 11, 2026

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Hallux Valgus; Bunion
• Other Study ID Numbers: CPL-2019-HV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No