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NCT Number: NCT04145882

Efficacy of Additional Osteotomies to Correct Hallux Valgus

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Lille sud, Lesquin, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

additional osteotomies

Procedure

varisation osteotomy, supination osteotomy or both

Primary outcomes

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

    Time frame: 6 months

    on weight bearing X-Rays

Secondary outcomes

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

    Time frame: 5 years

  2. American Orthopedic Foot and Ankle Forefoot Score (AOFAS)

    Time frame: 6 months

    Mini 0 (Worse) - Maxi 100 (Better)

  3. American Orthopedic Foot and Ankle Forefoot Score (AOFAS)

    Time frame: 5 years

    Mini 0 (Worse) - Maxi 100 (Better)

  4. Patient satisfaction (Likert scale)

    Time frame: 6 months

    very satisfied/satisfied/fairly satisfied/no satisfied

  5. Patient satisfaction (Likert scale)

    Time frame: 5 years

    very satisfied/satisfied/fairly satisfied/no satisfied

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2026
First posted
Oct 31, 2019
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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