Efficacy of Additional Osteotomies to Correct Hallux Valgus

Elsan

Status: Active, not recruiting

Conditions: Hallux Valgus

Treatments: Procedure: additional osteotomies

Study type: Interventional

Funder types: Other

Identifiers

NCT04145882

CPL-2019-HV

Details and patient eligibility

About

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

Enrollment: 515 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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515 participants in 4 patient groups

No additional osteotomy

Active Comparator group

Treatment:

Procedure: additional osteotomies

varisation osteotomy addition

Experimental group

Treatment:

Procedure: additional osteotomies

supination osteotomy addition

Experimental group

Treatment:

Procedure: additional osteotomies

both (varisation + supination) osteotomies addition.

Experimental group

Treatment:

Procedure: additional osteotomies