Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2026-01-02 @ 1:08 AM
Study NCT ID:
NCT04655950
Status:
COMPLETED
Last Update Posted:
2020-12-07
First Post:
2020-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immobilization and Neurological Complications in Patients With Vertebral Osteomyelitis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015299', 'term': 'Discitis'}], 'ancestors': [{'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013122', 'term': 'Spinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-30', 'studyFirstSubmitDate': '2020-02-04', 'studyFirstSubmitQcDate': '2020-11-30', 'lastUpdatePostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative description of main types of spine immobilization', 'timeFrame': 'inclusion', 'description': 'Type of bracing : smooth or rigid bracing, highness of bracing (cervical, thoracic, lumbar spine or both and level of the highest and lowest vertebrae included).'}], 'secondaryOutcomes': [{'measure': 'Frequency of neurological complications', 'timeFrame': 'inclusion, month 3 and month 6', 'description': 'Percentage of neurological complication at baseline, 3 and 6 months follow-up)\n\n* Percentage of major neurological signs (sphincter dysfunction and/or motor deficit and ASIA score) at baseline, 3 and 6 months follow-up\n* Percentage of minor neurological signs (radicular pain, reflex abolition, hypoesthesia) at baseline, 3 and 6 months follow-up'}, {'measure': 'MRI signs at baseline', 'timeFrame': 'inclusion, month 3 and month 6', 'description': 'Number of vertebrae involved, destruction of posterior arch, destruction of vertebrae, kyphosis, epidural phlegmon, spinal cord hypersignal, dural sac compression, anterior effacement of subarachnoidal space\n\nOswestry functional score at 3 and 6 months follow-up. Association between type and duration of spine immobilization and neurological complication'}, {'measure': 'Oswestry functional score at 3 and 6 months follow-up', 'timeFrame': 'inclusion, month 3 and month 6', 'description': 'Association between type and duration of spine immobilization and neurological complication'}, {'measure': 'Duration of Spine immobilization', 'timeFrame': 'month 6', 'description': 'Evaluation of the duration of immobilization of the spine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vertebral Osteomyelitis', 'Spine Immobilization', 'Neurological complications'], 'conditions': ['Vertebral Osteomyelitis', 'Spondylodiscitis']}, 'descriptionModule': {'briefSummary': 'Vertebral osteomyelitis is an infection of the intervertebral disk and adjacent vertebral plates with a non-negligible risk of neurological complications and handicap. If there are clear recommendations dealing with antibiotic therapy and surgery indications for this pathogen, the question of the immobilization will be remaining debate. The aim of the study was to describe protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections Centers. The secondary objectives were to evaluate the frequency of neurological complications in a large prospective cohort, and to identify clinical and imaging risk factors for neurological complications.\n\nThe investigators also aim to search for association between type and duration of spine immobilization and neurological status at the end of follow-up.', 'detailedDescription': "Study design is descriptive, prospective, multicentric, and the investigators have a single database centralized in Nantes University Hospital. Patient's data will be conserved and trapped anonymously and patients all give oral consent. Information letter is given to each patient.\n\nTypical study calendar :\n\nBaseline :\n\n* Patient information (letter and oral consent)\n* Clinical data and comorbidities collection\n* Neurological examination\n* Spine X-ray\n* MRI or CT-scan imaging to confirm diagnosis\n\nDuring Hospitalization\n\n* Date collection : spine immobilization modalities (type, duration, changes…), duration of bed rest\n* Other treatments (antibiotic therapy : molecules and duration)\n* Daily neurological examination\n\n 3 months follow-up visit : (if usually done by physician)\n* Clinical and neurological examination\n* Spine immobilization assessment\n* Spine X-ray\n* Oswestry questionary\n\n 6 months follow-up visit : finale visit (if usually done by physician)\n* Clinical and neurological examination\n* Spine immobilization assessment\n* Spine X-ray\n* Oswestry questionary"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Baseline :\n\n* Patient information (letter and oral consent)\n* Clinical data and comorbidities collection\n* Neurological examination\n* Spine X-ray\n* MRI or CT-scan imaging to confirm diagnosis\n\nDuring Hospitalization\n\n* Date collection : spine immobilization modalities (type, duration, changes…), duration of bed rest\n* Other treatments (antibiotic therapy : molecules and duration)\n* Daily neurological examination\n\n 3 months follow-up visit : (if usually done by physician)\n* Clinical and neurological examination\n* Spine immobilization assessment\n* Spine X-ray\n* Oswestry questionnary\n\n 6 months follow-up visit : finale visit (if usually done by physician)\n* Clinical and neurological examination\n* Spine immobilization assessment\n* Spine X-ray\n* Oswestry questionnary', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults patients, male and female\n* Hospitalized of a vertebral osteomyelitis in one of the Centers\n* Meeting the criteria for the definition of vertebral Osteomyelitis (typical imaging findings)\n* Microbiological proof of infection (blood culture or discovertebral biopsy) or high suspicion of infection (Compatible histology, good response to antibiotics and no differential diagnosis).\n\nExclusion Criteria:- Spine device infection\n\n* Recent spinal surgery less than 1month\n* Children under 18 years old\n* Under guardianship\n* Pregnant woman'}, 'identificationModule': {'nctId': 'NCT04655950', 'acronym': 'SPONDIMMO', 'briefTitle': 'Immobilization and Neurological Complications in Patients With Vertebral Osteomyelitis.', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'SPONDIMMO : Multicentered Descriptive Prospective Study of Immobilization and Neurological Complication in Patients With Vertebral Osteomyelitis.', 'orgStudyIdInfo': {'id': 'RC16_0214'}}, 'armsInterventionsModule': {'interventions': [{'name': 'protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections Centers', 'type': 'OTHER', 'description': 'Evaluation of the frequency of neurological complications in a large prospective cohort, and to identify clinical and imaging risk factors for neurological complications.\n\nWe search for association between type and duration of spine immobilization and neurological status at the end of follow-up'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'Angers University Hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Clermont ferrand University Hospital', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '85000', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'La Roche Sur Yon Hospital', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Paris University Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '29107', 'city': 'Quimper', 'country': 'France', 'facility': 'Quimper Hospital', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '44606', 'city': 'Saint-Nazaire', 'country': 'France', 'facility': 'Saint-Nazaire Hospital', 'geoPoint': {'lat': 47.27506, 'lon': -2.2179}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'facility': 'Tours University Hospital', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Benoit Le Goff, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}