Efficacy of Additional Osteotomies to Correct Hallux Valgus

Hallux Valgus Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04145882
• Other study ID #: CPL-2019-HV
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 11, 2019
• Est. completion date: September 11, 2026

Study information

• Verified date: February 2024
• Source: Elsan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 515
• Est. completion date: September 11, 2026
• Est. primary completion date: July 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bunion
• Hallux Valgus

Intervention

Procedure:
• additional osteotomies
varisation osteotomy, supination osteotomy or both

Locations

Country	Name	City	State
France	Clinique Lille sud	Lesquin
France	Clinique du Parc Lyon	Lyon
France	Clinique Mégival	Saint-Aubin-sur-Scie
France	Clinique de l'Union	Saint-Jean

Sponsors (1)

Lead Sponsor	Collaborator
Elsan

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients having both Hallux Valgus Angle >15° and InterMetatarsal Angle >10°	on weight bearing X-Rays	6 months
Secondary	Recurrence of hallux valgus (HVA>20°).		5 years
Secondary	American Orthopedic Foot and Ankle Forefoot Score (AOFAS)	Mini 0 (Worse) - Maxi 100 (Better)	6 months
Secondary	American Orthopedic Foot and Ankle Forefoot Score (AOFAS)	Mini 0 (Worse) - Maxi 100 (Better)	5 years
Secondary	Patient satisfaction (Likert scale)	very satisfied/satisfied/fairly satisfied/no satisfied	6 months
Secondary	Patient satisfaction (Likert scale)	very satisfied/satisfied/fairly satisfied/no satisfied	5 years