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Impact of a Dynamic Dressing in the Management of Unoperated Hallux Valgus (DYNHALLUX)

NCT04732897 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-07-22

No results posted yet for this study

Summary

Hallux Valgus (HV) is a lateral deviation of the big toe. HV is a deformity of the forefoot centered on the 1st radius (1st metatarsal and big toe). This deformation is characterized by:

* a big toe (hallux) deviated outwards (valgus greater than 12 °)
* a first metatarsal moved medially (varus) (angle M1 / M2\> 10 °). We also note the existence of an exostosis formed by the apex of the angle between the 1st metatarsal deviated inwards and the big toe deported outwards. This exostosis corresponds to the head of the 1st metatarsal.

In addition to the pain and the unaesthetic nature induced by this deviation, the modifications of the skeletal axes of the foot cause disorders of its function but also of the joints of the lower limb during standing, walking and running. Axis defects of the lower limbs in varum or valgum also cause deformities in the rearfoot, midfoot and forefoot.

There is no non-surgical curative treatment for this deformity. Different conservative treatment options have been offered for first-line treatment, including different types of physiotherapy, wearing rigid insoles or splints.

Wearing rigid insoles is indicated to "counter" the valgic pressure, thereby reducing pain and high plantar pressure, in patients with HV. Their hardness, expressed in SHORE units, must be greater than 65. By countering the valgic pressure (rearfoot and midfoot), the rigid soles make it possible to contain the development of deformation and stabilize the axis of the first spoke. The speed of hallux deformation is therefore greatly reduced if the soles are worn diligently. But there is little or no impact on the correction of the deformity, but it is stabilized as it is without rapid and major worsening. Indeed, soles with a hardness greater than or equal to 65 SHORE make it possible to avoid the valgum of the hindfoot and midfoot under load and when walking.

Wearing a dynamic splint was studied in a recently published prospective randomized study conducted between 2011 and 2013. This study, concluding that the dynamic splint is not effective in reducing the angle of deformation of the HV, nevertheless shows the reduction in pain during walking and running. The limits of the study lie in the pace of wearing the splint, left to the discretion of patients, during their rest period, and in the duration of the operation, which is not precisely described.

Conditions

  • Hallux Abductovalgus

Interventions

PROCEDURE

dynamic dressing

Dynamic dressing is made by bandages of the foot with gauze pad, stretchable adhesive tape and elastic compression band

Sponsors & Collaborators

  • Centre Hospitalier Annecy Genevois

    lead OTHER

Principal Investigators

  • Guy Allamel, PhD · CH Annecy Genevois

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-22
Primary Completion
2022-01-25
Completion
2022-01-25

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04732897 on ClinicalTrials.gov