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

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ClinicalTrials.gov Identifier: NCT04732897
Recruitment Status : Recruiting
First Posted : February 1, 2021
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Annecy Genevois

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hallux Abductovalgus Procedure: dynamic dressing Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label randomized trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of a Dynamic Dressing in the Management of Unoperated Hallux Valgus With Theoretical Indication for Surgery: Randomized Open Trial
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bunion
MedlinePlus related topics: Foot Health

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control arm
wearing made-to-measure soles with SHORE greater than or equal to 65 (standard of care)
Experimental: Interventional arm
wearing made-to-measure soles with SHORE greater than or equal to 65 + dynamic dressing of the joint
 Procedure: dynamic dressing
Dynamic dressing is made by bandages of the foot with gauze pad, stretchable adhesive tape and elastic compression band


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline M1 / P1 angle at day 75 measured by weightbearing foot radiograph [ Time Frame: radiograph between day 0 less than 6 months and day 0 and radiograph at day 75 ]
    M1 / P1 angle measured before and after intervention


Secondary Outcome Measures :
  1. Variation of the M1 / M2 angle measured by weightbearing foot radiograph [ Time Frame: radiograph between day 0 less than 6 months and day 0 and radiograph at day 75 ]
    M1 / M2 angle measured before and after intervention

  2. Variation of the M1 / P1 and M1/M2 angle measured by weightbearing foot radiograph at long time [ Time Frame: radiograph at day 75 and at month 6 and month 12 ]
    M1/P1 et M1 / M2 angle measured just at the end of the intervention and at long time

  3. 12-month surgery rate [ Time Frame: month 12 ]
    use of surgery 12 months after randomization

  4. Quality of life measured by the American Orthopedic Foot and Ankle Society score [ Time Frame: day 0, day 75, month 6 and month 12 ]
    American Orthopedic Foot and Ankle Society - hallux metatarsophalangeal interphalangeal scale (min = 0, max = 100, higher scores mean a better outcome).

  5. Quality of life measured by the Foot Function Index score [ Time Frame: day 0, day 75, month 6 and month 12 ]
    Foot Fonction Index (min = 0, max = 100, higher scores mean a worse outcome).

  6. Quality of life measured by the EuroQol Visual Analogue Scale [ Time Frame: day 0, day 75, month 6 and month 12 ]
    EuroQol Visual Analogue Scale (min = 0, max = 100, higher scores mean a better outcome.

  7. Pain Visual Analogue Scale [ Time Frame: day 0, day 75, month 6 and month 12 ]
    Pain Visual Analogue Scale (min = 0, max = 10, higher scores mean a worse outcome).

  8. Physician clinical qualitative assessement of skin condition [ Time Frame: day 0 and day 75 ]
    Presence or absence of irritation, blisters, redness, itching


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04732897


Contacts
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Contact: Anne-Laure Claudel +33450637032 alclaudel@ch-annecygenevois.fr
Contact: Guy Allamel, PhD gallamel@ch-annecygenevois.fr

Locations
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France
Centre Hospitalier Annecy Genevois Recruiting
Metz-Tessy, France, 74374
Contact: Guy Allamel       gallamel@ch-annecygenevois.fr   
Sub-Investigator: Charline Houillon         
Sponsors and Collaborators
Centre Hospitalier Annecy Genevois
Investigators
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Principal Investigator: Guy Allamel, PhD CH Annecy Genevois
More Information
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Responsible Party: Centre Hospitalier Annecy Genevois
ClinicalTrials.gov Identifier: NCT04732897    
Other Study ID Numbers: 18-45
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hallux Valgus
Foot Deformities
Musculoskeletal Diseases