Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04732897
Status:
TERMINATED
Last Update Posted:
2022-07-22
First Post:
2021-01-26
Brief Title:
Impact of a Dynamic Dressing in the Management of Unoperated Hallux Valgus DYNHALLUX
Sponsor:
Centre Hospitalier Annecy Genevois
Organization:
Centre Hospitalier Annecy Genevois
Study Overview
Official Title:
Impact of a Dynamic Dressing in the Management of Unoperated Hallux Valgus With Theoretical Indication for Surgery Randomized Open Trial
Status:
TERMINATED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment issue
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DYNHALLUX
Brief 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
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
Detailed 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 ie wearer of made-to-measure soles with SHORE greater than or equal to 65 for at least 2 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None