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Recruitment issue
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | No Intervention | wearing made-to-measure soles with SHORE greater than or equal to 65 (standard of care) | |
| Interventional arm | Experimental | wearing made-to-measure soles with SHORE greater than or equal to 65 + dynamic dressing of the joint |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dynamic dressing | Procedure | Dynamic dressing is made by bandages of the foot with gauze pad, stretchable adhesive tape and elastic compression band |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline M1 / P1 angle at day 75 measured by weightbearing foot radiograph | M1 / P1 angle measured before and after intervention | radiograph between day 0 less than 6 months and day 0 and radiograph at day 75 |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of the M1 / M2 angle measured by weightbearing foot radiograph | M1 / M2 angle measured before and after intervention | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guy Allamel, PhD | CH Annecy Genevois | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Annecy Genevois | Metz-Tessy | 74374 | France |
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| ID | Term |
|---|---|
| D006215 | Hallux Valgus |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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Open-label randomized trial
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M1/P1 et M1 / M2 angle measured just at the end of the intervention and at long time |
| radiograph at day 75 and at month 6 and month 12 |
| 12-month surgery rate | use of surgery 12 months after randomization | 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). | 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). | 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. | 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). | day 0, day 75, month 6 and month 12 |
| Physician clinical qualitative assessement of skin condition | Presence or absence of irritation, blisters, redness, itching | day 0 and day 75 |