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Clinical Trials/NCT04145882
NCT04145882
Active, not recruiting
Not Applicable

Is it Better to Add Supination Osteotomy, Varisation Osteotomy, or Both to Distal Chevron as Part of Hallux Valgus Management : a Prospective Randomized Trial

Elsan4 sites in 1 country515 target enrollmentSeptember 11, 2019
ConditionsHallux Valgus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hallux Valgus
Sponsor
Elsan
Enrollment
515
Locations
4
Primary Endpoint
Rate of patients having both Hallux Valgus Angle >15° and InterMetatarsal Angle >10°
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 11, 2019
End Date
September 11, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Elsan
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: 6 months

on weight bearing X-Rays

Secondary Outcomes

  • Recurrence of hallux valgus (HVA>20°).(5 years)
  • American Orthopedic Foot and Ankle Forefoot Score (AOFAS)(5 years)
  • Patient satisfaction (Likert scale)(5 years)

Study Sites (4)

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