Impact of a Dynamic Dressing in the Management of Unoperated Hallux Valgus (DYNHALLUX) (DYNHALLUX)
Primary Purpose
Hallux Abductovalgus
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
dynamic dressing
Sponsored by
About this trial
This is an interventional treatment trial for Hallux Abductovalgus
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
Sites / Locations
- Centre Hospitalier Annecy Genevois
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control arm
Interventional arm
Arm Description
wearing made-to-measure soles with SHORE greater than or equal to 65 (standard of care)
wearing made-to-measure soles with SHORE greater than or equal to 65 + dynamic dressing of the joint
Outcomes
Primary Outcome Measures
Change from baseline M1 / P1 angle at day 75 measured by weightbearing foot radiograph
M1 / P1 angle measured before and after intervention
Secondary Outcome Measures
Variation of the M1 / M2 angle measured by weightbearing foot radiograph
M1 / M2 angle measured before and after intervention
Variation of the M1 / P1 and M1/M2 angle measured by weightbearing foot radiograph at long time
M1/P1 et M1 / M2 angle measured just at the end of the intervention and at long time
12-month surgery rate
use of surgery 12 months after randomization
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).
Quality of life measured by the Foot Function Index score
Foot Fonction Index (min = 0, max = 100, higher scores mean a worse outcome).
Quality of life measured by the EuroQol Visual Analogue Scale
EuroQol Visual Analogue Scale (min = 0, max = 100, higher scores mean a better outcome.
Pain Visual Analogue Scale
Pain Visual Analogue Scale (min = 0, max = 10, higher scores mean a worse outcome).
Physician clinical qualitative assessement of skin condition
Presence or absence of irritation, blisters, redness, itching
Full Information
NCT ID
NCT04732897
First Posted
January 26, 2021
Last Updated
July 19, 2022
Sponsor
Centre Hospitalier Annecy Genevois
1. Study Identification
Unique Protocol Identification Number
NCT04732897
Brief Title
Impact of a Dynamic Dressing in the Management of Unoperated Hallux Valgus (DYNHALLUX)
Acronym
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment issue
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
January 25, 2022 (Actual)
Study Completion Date
January 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Annecy Genevois
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Abductovalgus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open-label randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
wearing made-to-measure soles with SHORE greater than or equal to 65 (standard of care)
Arm Title
Interventional arm
Arm Type
Experimental
Arm Description
wearing made-to-measure soles with SHORE greater than or equal to 65 + dynamic dressing of the joint
Intervention Type
Procedure
Intervention Name(s)
dynamic dressing
Intervention Description
Dynamic dressing is made by bandages of the foot with gauze pad, stretchable adhesive tape and elastic compression band
Primary Outcome Measure Information:
Title
Change from baseline M1 / P1 angle at day 75 measured by weightbearing foot radiograph
Description
M1 / P1 angle measured before and after intervention
Time Frame
radiograph between day 0 less than 6 months and day 0 and radiograph at day 75
Secondary Outcome Measure Information:
Title
Variation of the M1 / M2 angle measured by weightbearing foot radiograph
Description
M1 / M2 angle measured before and after intervention
Time Frame
radiograph between day 0 less than 6 months and day 0 and radiograph at day 75
Title
Variation of the M1 / P1 and M1/M2 angle measured by weightbearing foot radiograph at long time
Description
M1/P1 et M1 / M2 angle measured just at the end of the intervention and at long time
Time Frame
radiograph at day 75 and at month 6 and month 12
Title
12-month surgery rate
Description
use of surgery 12 months after randomization
Time Frame
month 12
Title
Quality of life measured by the American Orthopedic Foot and Ankle Society score
Description
American Orthopedic Foot and Ankle Society - hallux metatarsophalangeal interphalangeal scale (min = 0, max = 100, higher scores mean a better outcome).
Time Frame
day 0, day 75, month 6 and month 12
Title
Quality of life measured by the Foot Function Index score
Description
Foot Fonction Index (min = 0, max = 100, higher scores mean a worse outcome).
Time Frame
day 0, day 75, month 6 and month 12
Title
Quality of life measured by the EuroQol Visual Analogue Scale
Description
EuroQol Visual Analogue Scale (min = 0, max = 100, higher scores mean a better outcome.
Time Frame
day 0, day 75, month 6 and month 12
Title
Pain Visual Analogue Scale
Description
Pain Visual Analogue Scale (min = 0, max = 10, higher scores mean a worse outcome).
Time Frame
day 0, day 75, month 6 and month 12
Title
Physician clinical qualitative assessement of skin condition
Description
Presence or absence of irritation, blisters, redness, itching
Time Frame
day 0 and day 75
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Allamel, PhD
Organizational Affiliation
CH Annecy Genevois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Annecy Genevois
City
Metz-Tessy
ZIP/Postal Code
74374
Country
France
12. IPD Sharing Statement
Learn more about this trial
Impact of a Dynamic Dressing in the Management of Unoperated Hallux Valgus (DYNHALLUX)
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