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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)

C

Centre Hospitalier le Mans

Status

Unknown

Conditions

Distal Metatarsal Mini-invasive Osteotomy (DMMO)

Treatments

Other: podobarometry

Study type

Interventional

Funder types

Other

Identifiers

NCT04823169
CHM-2020/S11/09

Details and patient eligibility

About

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)

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

70 participants in 1 patient group

podobarometry
Experimental group
Description:
podobarometric measures at day7 and day 30
Treatment:
Other: podobarometry

Trial contacts and locations

1

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Central trial contact

Jean-Michel AUDEBRAND, MD; Christelle JADEAU

Data sourced from clinicaltrials.gov

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