Efficacy of Additional Osteotomies to Correct Hallux Valgus

NCT04145882 | Active Not Recruiting

• 1 other identifier: CPL-2019-HV
• Study Type: interventional
• Target: 515
• Locations: 1 country
• Sites: 4

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

Conditions

Hallux Valgus

Outcome Measures

Primary Outcomes (1)

• Rate of patients having both Hallux Valgus Angle >15° and InterMetatarsal Angle >10°

  on weight bearing X-Rays

  6 months

Secondary Outcomes (5)

• Recurrence of hallux valgus (HVA>20°).

  5 years

• American Orthopedic Foot and Ankle Forefoot Score (AOFAS)

  6 months

• American Orthopedic Foot and Ankle Forefoot Score (AOFAS)

  5 years

• Patient satisfaction (Likert scale)

  6 months

• Patient satisfaction (Likert scale)

  5 years

Study Arms (4)

No additional osteotomy

ACTIVE COMPARATOR

Procedure: additional osteotomies

varisation osteotomy addition

EXPERIMENTAL

Procedure: additional osteotomies

supination osteotomy addition

EXPERIMENTAL

Procedure: additional osteotomies

both (varisation + supination) osteotomies addition.

EXPERIMENTAL

Procedure: additional osteotomies

Interventions

additional osteotomies PROCEDURE

varisation osteotomy, supination osteotomy or both

No additional osteotomy; both (varisation + supination) osteotomies addition.; supination osteotomy addition; varisation osteotomy addition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient older than 18 years.
• Informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elsan: lead

Study Sites (4)

Clinique Lille sud

Lesquin, 59810, France

Location

Clinique du Parc Lyon

Lyon, 69006, France

Location

Clinique Mégival

Saint-Aubin-sur-Scie, 76550, France

Location

Clinique de l'Union

Saint-Jean, 31240, France

Location

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: September 11, 2019
• Primary Completion: July 29, 2021
• Study Completion (Estimated): September 11, 2026
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)