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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Dynamic dressing is made by bandages of the foot with gauze pad, stretchable adhesive tape and elastic compression band
Centre Hospitalier Annecy Genevois
Metz-Tessy, France
Change from baseline M1 / P1 angle at day 75 measured by weightbearing foot radiograph
M1 / P1 angle measured before and after intervention
Time frame: radiograph between day 0 less than 6 months and day 0 and radiograph at day 75
Variation of the M1 / M2 angle measured by weightbearing foot radiograph
M1 / M2 angle measured before and after intervention
Time frame: radiograph between day 0 less than 6 months and day 0 and radiograph at day 75
Variation of the M1 / P1 and M1/M2 angle measured by weightbearing foot radiograph at long time
M1/P1 et M1 / M2 angle measured just at the end of the intervention and at long time
Time frame: radiograph at day 75 and at month 6 and month 12
12-month surgery rate
use of surgery 12 months after randomization
Time frame: month 12
Quality of life measured by the American Orthopedic Foot and Ankle Society score
American Orthopedic Foot and Ankle Society - hallux metatarsophalangeal interphalangeal scale (min = 0, max = 100, higher scores mean a better outcome).
Time frame: day 0, day 75, month 6 and month 12
Quality of life measured by the Foot Function Index score
Foot Fonction Index (min = 0, max = 100, higher scores mean a worse outcome).
Time frame: day 0, day 75, month 6 and month 12
Quality of life measured by the EuroQol Visual Analogue Scale
EuroQol Visual Analogue Scale (min = 0, max = 100, higher scores mean a better outcome.
Time frame: day 0, day 75, month 6 and month 12
Pain Visual Analogue Scale
Pain Visual Analogue Scale (min = 0, max = 10, higher scores mean a worse outcome).
Time frame: day 0, day 75, month 6 and month 12
Physician clinical qualitative assessement of skin condition
Presence or absence of irritation, blisters, redness, itching
Time frame: day 0 and day 75
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