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

NCT ID: NCT04823169

Last Updated: 2021-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-22

Study Completion Date

2023-09-22

Brief Summary

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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)

Detailed Description

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Conditions

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Distal Metatarsal Mini-invasive Osteotomy (DMMO)

Keywords

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Distal Metatarsal Mini-invasive Osteotomy DMMO Podobarometry

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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podobarometry

podobarometric measures at day7 and day 30

Group Type EXPERIMENTAL

podobarometry

Intervention Type OTHER

podobarometric measures on day 7 and day 30

Interventions

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podobarometry

podobarometric measures on day 7 and day 30

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier le Mans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Du Mans

Le Mans, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christelle JADEAU

Role: CONTACT

Phone: 02 44 71 07 81

Email: [email protected]

Jean-Michel AUDEBRAND, MD

Role: CONTACT

Phone: 02 43 43 43 43

Email: [email protected]

Facility Contacts

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Christelle JADEAU

Role: primary

Other Identifiers

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CHM-2020/S11/09

Identifier Type: -

Identifier Source: org_study_id