Efficacy of Additional Osteotomies to Correct Hallux Valgus

Sponsor

Klouche-Clinical-Research (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04145882

Collaborator

Elsan (Other)

515

Enrollment

Locations

Arms

Anticipated Duration (Months)

128.8

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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 (lateraly) distal chevron associated with a release of the metatarsosesamoid suspensory ligament and a Akin procedure on P1. Nevertheless this procedure does not correct déformation 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

Condition or Disease	Intervention/Treatment	Phase
Hallux Valgus	Procedure: additional osteotomies	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

515 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 11, 2019

Actual Primary Completion Date :

Jul 29, 2021

Anticipated Study Completion Date :

Sep 11, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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, polyomyelitis, compartment syndrome sequelae)
Clinical or X-ray degenerative signs (Hallux rigidus) or irreducible deformations (MTP1 arthrodesis indications).
Patient who declined the study.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clinique Lille sud	Lesquin	France	59810
2	Clinique du Parc Lyon	Lyon	France	69006
3	Clinique Mégival	Saint-Aubin-sur-Scie	France	76550
4	Clinique de l'Union	Saint-Jean	France	31240

Sponsors and Collaborators

Klouche-Clinical-Research
Elsan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Klouche-Clinical-Research

ClinicalTrials.gov Identifier:

NCT04145882

Other Study ID Numbers:

CPL-2019-HV

First Posted:

Oct 31, 2019

Last Update Posted:

Aug 5, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Hallux Valgus

Bunion

Study Results

No Results Posted as of Aug 5, 2021