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Painful and Barometric Dynamic Monitoring in the Aftermath of Foot Surgery Using the Distal Metatarsal Mini-invasive Osteotomy (DMMO) Method (BAROC)

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ClinicalTrials.gov Identifier: NCT04823169
Recruitment Status : Recruiting
First Posted : March 30, 2021
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier le Mans

Brief Summary:

The definitive treatment of disabling metatarsalgia requires surgery. In recent years, a percutaneous technique has been developed, the "Distal Metatarsal Mini-invasive Osteotomy" (DMMO). It consists of performing extra-articular osteotomies that are not osteosynthesized and maintained during the time of bone consolidation by a dressing and specific offloading footwear.The patient is encouraged to resume walking immediately after the procedure, as full plantar support is an integral part of the surgical concept. The goal is to actively modify the distribution of all metatarsal supports by the pressure exerted on the ground during walking and by tendon tensions, in order to reduce forefoot deformities.

DMMO offers many advantages over traditional techniques, but it remains a painful forefoot surgery in the short term despite the systematic use of analgesics and the wearing of a dedicated therapeutic shoe.

The study will seek to identify the predictive character of podobarometric parameters at walking (D+7 and D+30 post-op), between patients who will require a palliative solution versus those who will not (D+90)


Condition or disease Intervention/treatment Phase
Distal Metatarsal Mini-invasive Osteotomy (DMMO) Other: podobarometry Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Painful and Barometric Dynamic Monitoring in the Aftermath of Foot Surgery Using the Distal Metatarsal Mini-invasive Osteotomy (DMMO) Method.
Actual Study Start Date : March 22, 2021
Estimated Primary Completion Date : September 22, 2023
Estimated Study Completion Date : September 22, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: podobarometry
podobarometric measures at day7 and day 30
Other: podobarometry
podobarometric measures on day 7 and day 30




Primary Outcome Measures :
  1. podobarographic parameters (plantar pressures) predictive of the need for a palliative foot orthosis [ Time Frame: 90 days after surgery ]
    Plantar pressures were measured by podobarometric Platform (FREEMED Platform)


Secondary Outcome Measures :
  1. Compare daily walk pain kinetics over one month postoperatively in patients requesting palliative solutions at 3 months (requesters) versus those not requesting them (non-requesters) [ Time Frame: 90 days after surgery ]
    Daily walk pain was measured by questionnaire (Google form) completed by patient every day during 30 days



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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:

  • Adult person
  • Affiliated or beneficiary of a statutory social insurance scheme
  • Free ans informed consent
  • Following foot surgery like DMMO only or DMMO and hallux valgus

Exclusion Criteria:

  • Minor or legally protect adult
  • Amputation disturbing the natural course of the step
  • Osteoarticular diseases/sequelae affecting walking and/or balance
  • Neuromuscular diseases/sequelae affecting walking and/or balance
  • Vestibular disorders affecting balance
  • Patients requiring a walking aid (e.g., walker)
  • Pregnant woman
  • Patient with dementia who are unable to follow verbal instructions

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): NCT04823169


Contacts
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Contact: Christelle JADEAU 02 44 71 07 81 cjadeau@ch-lemans.fr
Contact: Jean-Michel AUDEBRAND, MD 02 43 43 43 43 jmaudebrand@ch-lemans.fr

Locations
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France
Centre Hospitalier Du Mans Recruiting
Le Mans, France, 72000
Contact: Christelle JADEAU    02 44 71 07 81    cjadeau@ch-lemans.fr   
Sponsors and Collaborators
Centre Hospitalier le Mans
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Responsible Party: Centre Hospitalier le Mans
ClinicalTrials.gov Identifier: NCT04823169    
Other Study ID Numbers: CHM-2020/S11/09
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier le Mans:
Distal Metatarsal Mini-invasive Osteotomy
DMMO
Podobarometry