Distal Metatarsal Mini-invasive Osteotomy (DMMO) Clinical Trial
— BAROCOfficial title:
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)
| Status | Recruiting |
| Enrollment | 70 |
| Est. completion date | September 22, 2023 |
| Est. primary completion date | September 22, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Du Mans | Le Mans |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier le Mans |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | podobarographic parameters (plantar pressures) predictive of the need for a palliative foot orthosis | Plantar pressures were measured by podobarometric Platform (FREEMED Platform) | 90 days after surgery | |
| Secondary | 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) | Daily walk pain was measured by questionnaire (Google form) completed by patient every day during 30 days | 90 days after surgery |