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

Centre Hospitalier Annecy Genevois

Status

Terminated

Conditions

Hallux Abductovalgus

Treatments

Procedure: dynamic dressing

Study type

Interventional

Funder types

Other

Identifiers

NCT04732897

18-45

Details and patient eligibility

About

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.

Full description

The hypothesis of the study is that a dynamic joint dressing, associated with a rigid orthopedic insole, would make it possible to "reverse" the deformation and re-focus the angles of deformation of the first ray in patients with a HV and already stabilized, i.e. wearer of made-to-measure soles with SHORE greater than or equal to 65 for at least 2 months.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

hallux valgus on at least one foot theoretically requiring surgical management within 12 months
reducible hallux valgus
wearing custom-made orthopedic insoles made by a biomechanical podiatrist - SHORE ≥ 65 - for at least 2 months at the time of inclusion
beneficiary of a social security scheme
informed of the study and signed informed consent form

Exclusion criteria

History of hallux valgus correction surgery on the affected foot
History of traumatic lesion of the M1-P1 metatarsophalangeal joint of the affected foot
Skin pathology limiting or contraindicating the possibility of dressings according to the judgment of the investigator (eg dyshidrotic eczema, psoriasis or other problematic skin damage located in the foot)
Acute bursitis
Clinical and / or radiological stage 1 or more osteoarthritis according to the criteria of Kellgren and Lawrence
Non-stabilized diabetes and / or diabetes with micro / macrovascular complications
Patients with neuropathy
History of gout
History of rheumatic pathology
Obliterating arteriopathy of the lower limbs of stage II or more according to the classification of Leriche and Fontaine
Pregnant woman
Patients under tutorship or curatorship
Patients under legal protection
Patients who do not understand French