Clinical trial NCT04732897: Impact of a Dynamic Dressing in the Management of Unoperated Hallux Valgus (DYNHALLUX)
Official title: Impact of a Dynamic Dressing in the Management of Unoperated Hallux Valgus With Theoretical Indication for Surgery: Randomized Open Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hallux Abductovalgus
Lead sponsor: Centre Hospitalier Annecy Genevois
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label randomized trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline M1 / P1 angle at day 75 measured by weightbearing foot radiograph
timeFrame: radiograph between day 0 less than 6 months and day 0 and radiograph at day 75
Secondary outcomes:
measure: Variation of the M1 / M2 angle measured by weightbearing foot radiograph
timeFrame: radiograph between day 0 less than 6 months and day 0 and radiograph at day 75
measure: Variation of the M1 / P1 and M1/M2 angle measured by weightbearing foot radiograph at long time
timeFrame: radiograph at day 75 and at month 6 and month 12
measure: 12-month surgery rate
timeFrame: month 12
measure: Quality of life measured by the American Orthopedic Foot and Ankle Society score
timeFrame: day 0, day 75, month 6 and month 12
measure: Quality of life measured by the Foot Function Index score
timeFrame: day 0, day 75, month 6 and month 12
measure: Quality of life measured by the EuroQol Visual Analogue Scale
timeFrame: day 0, day 75, month 6 and month 12
measure: Pain Visual Analogue Scale
timeFrame: day 0, day 75, month 6 and month 12
measure: Physician clinical qualitative assessement of skin condition
timeFrame: day 0 and day 75
Other outcomes:
Locations:
city: Metz-Tessy
country: France
facility: Centre Hospitalier Annecy Genevois
Study officials:
affiliation: CH Annecy Genevois
name: Guy Allamel, PhD
role: PRINCIPAL_INVESTIGATOR
References: