Painful and Barometric Dynamic Monitoring in the Aftermath of Foot Surgery Using the Distal Metatarsal Mini-invasive Osteotomy (DMMO) Method (BAROC)
Painful and Barometric Dynamic Monitoring in the Aftermath of Foot Surgery Using the Distal Metatarsal Mini-invasive Osteotomy (DMMO) Method.
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)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jean-Michel AUDEBRAND, MD
- Phone Number: 02 43 43 43 43
- Email: jmaudebrand@ch-lemans.fr
Study Locations
-
-
-
Le Mans, France, 72000
- Recruiting
- Centre Hospitalier Du Mans
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: podobarometry
podobarometric measures at day7 and day 30
|
podobarometric measures on day 7 and day 30
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
90 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
90 days after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CHM-2020/S11/09
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.