Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-01 @ 11:02 PM
Study NCT ID:
NCT04823169
Status:
UNKNOWN
Last Update Posted:
2021-03-30
First Post:
2021-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Painful and Barometric Dynamic Monitoring in the Aftermath of Foot Surgery Using the Distal Metatarsal Mini-invasive Osteotomy (DMMO) Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-09-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-29', 'studyFirstSubmitDate': '2021-03-25', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'podobarographic parameters (plantar pressures) predictive of the need for a palliative foot orthosis', 'timeFrame': '90 days after surgery', 'description': 'Plantar pressures were measured by podobarometric Platform (FREEMED Platform)'}], 'secondaryOutcomes': [{'measure': '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)', 'timeFrame': '90 days after surgery', 'description': 'Daily walk pain was measured by questionnaire (Google form) completed by patient every day during 30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Distal Metatarsal Mini-invasive Osteotomy', 'DMMO', 'Podobarometry'], 'conditions': ['Distal Metatarsal Mini-invasive Osteotomy (DMMO)']}, 'descriptionModule': {'briefSummary': '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.\n\nDMMO 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.\n\nThe 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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult person\n* Affiliated or beneficiary of a statutory social insurance scheme\n* Free ans informed consent\n* Following foot surgery like DMMO only or DMMO and hallux valgus\n\nExclusion Criteria:\n\n* Minor or legally protect adult\n* Amputation disturbing the natural course of the step\n* Osteoarticular diseases/sequelae affecting walking and/or balance\n* Neuromuscular diseases/sequelae affecting walking and/or balance\n* Vestibular disorders affecting balance\n* Patients requiring a walking aid (e.g., walker)\n* Pregnant woman\n* Patient with dementia who are unable to follow verbal instructions'}, 'identificationModule': {'nctId': 'NCT04823169', 'acronym': 'BAROC', 'briefTitle': 'Painful and Barometric Dynamic Monitoring in the Aftermath of Foot Surgery Using the Distal Metatarsal Mini-invasive Osteotomy (DMMO) Method', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier le Mans'}, 'officialTitle': 'Painful and Barometric Dynamic Monitoring in the Aftermath of Foot Surgery Using the Distal Metatarsal Mini-invasive Osteotomy (DMMO) Method.', 'orgStudyIdInfo': {'id': 'CHM-2020/S11/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'podobarometry', 'description': 'podobarometric measures at day7 and day 30', 'interventionNames': ['Other: podobarometry']}], 'interventions': [{'name': 'podobarometry', 'type': 'OTHER', 'description': 'podobarometric measures on day 7 and day 30', 'armGroupLabels': ['podobarometry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72000', 'city': 'Le Mans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christelle JADEAU', 'role': 'CONTACT', 'email': 'cjadeau@ch-lemans.fr', 'phone': '02 44 71 07 81'}], 'facility': 'Centre Hospitalier Du Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}], 'centralContacts': [{'name': 'Christelle JADEAU', 'role': 'CONTACT', 'email': 'cjadeau@ch-lemans.fr', 'phone': '02 44 71 07 81'}, {'name': 'Jean-Michel AUDEBRAND, MD', 'role': 'CONTACT', 'email': 'jmaudebrand@ch-lemans.fr', 'phone': '02 43 43 43 43'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier le Mans', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}