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

NCT04732897 | Terminated

• 1 other identifier: 18-45
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallux Abductovalgus

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Variation of the M1 / M2 angle measured by weightbearing foot radiograph

  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

  radiograph at day 75 and at month 6 and month 12

• 12-month surgery rate

  month 12

• Quality of life measured by the American Orthopedic Foot and Ankle Society score

  day 0, day 75, month 6 and month 12

• Quality of life measured by the Foot Function Index score

  day 0, day 75, month 6 and month 12

Study Arms (2)

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

Procedure: dynamic dressing

Interventions

dynamic dressing PROCEDURE

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

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hallux valgus on at least one foot theoretically requiring surgical management within 12 months
• reducible hallux valgus
• beneficiary of a social security scheme
• informed of the study and signed informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead

Study Sites (1)

Centre Hospitalier Annecy Genevois

Metz-Tessy, 74374, France

Location

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Officials

• Guy Allamel, PhD

  CH Annecy Genevois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label randomized trial

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 1, 2021
• Study Start: April 22, 2021
• Primary Completion: January 25, 2022
• Study Completion: January 25, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

FR (1)