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

NCT ID: NCT04732897

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-22
• Study Completion Date: 2022-01-25

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.

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, i.e. wearer of made-to-measure soles with SHORE greater than or equal to 65 for at least 2 months.

Conditions

Hallux Abductovalgus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control arm

wearing made-to-measure soles with SHORE greater than or equal to 65 (standard of care)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventional arm

wearing made-to-measure soles with SHORE greater than or equal to 65 + dynamic dressing of the joint

Group Type: EXPERIMENTAL

dynamic dressing

Intervention Type: PROCEDURE

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

Interventions

dynamic dressing

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Annecy Genevois

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guy Allamel, PhD

Role: PRINCIPAL_INVESTIGATOR

CH Annecy Genevois

Locations

Centre Hospitalier Annecy Genevois

Metz-Tessy, , France

Countries

France

Other Identifiers

18-45

Identifier Type: -

Identifier Source: org_study_id