Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-20 @ 1:04 AM
Study NCT ID:
NCT02881593
Status:
WITHDRAWN
Last Update Posted:
2018-08-10
First Post:
2016-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Quality of Post Release on Scanners Operating in Minimally Invasive Arthrodesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000844', 'term': 'Ankylosis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The investiagtor abandoned the project.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2016-08-24', 'studyFirstSubmitQcDate': '2016-08-26', 'lastUpdatePostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparing the measured height of the foramen on the CT scanner', 'timeFrame': 'Day -1 and Day 1 after surgery', 'description': 'The evaluation of the primary objective criterion is comparing the height of the foramen measured on CT pre- and post-opéraoires between the lower edge of the overlying pedicle and the top edge of the pedicle underlying the sagittal sections.'}, {'measure': 'Assessment of change of MRI volume of dural sac', 'timeFrame': 'Day -1 and Day 1 after surgery', 'description': 'For central stenosis, Postoperative MRI will be performed and the volume of the dural sac will be compared to preoperative MRI on axial slices'}], 'secondaryOutcomes': [{'measure': 'Assessment of change of Oswestry score', 'timeFrame': 'Day -1 and Day 1 after surgery', 'description': 'Oswestry score (\\<30%: State almost normal 30 to 50%: Moderate disability 50% to 70%: Severe disability\\> 70%: full disability)'}, {'measure': 'Evaluation of pain by visual analogue scale VAS', 'timeFrame': 'Day -1 and Day 1 after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Operating in Minimally Invasive'], 'conditions': ['Arthrodesis']}, 'descriptionModule': {'briefSummary': 'For twenty years, as for other surgical disciplines, new minimally invasive techniques have been developed with the main goal the reduction of muscle trauma associated with the surrounding roads "classic" and reduce morbidity linked to this one.\n\nMore recently, minimally invasive methods dedicated to spinal surgery were established, for the treatment of herniated discs initially, then for narrow lumbar canals.\n\nThe canal release on minimally invasive fusion, using a tubular system for muscle retraction is a new technique that has proven effective: post operative pain reduction of hospital stay and blood loss.\n\nThe objective of the study is to investigate the quality of ductal release in these minimally invasive fusions.\n\nMain objective of the study: Evaluation of the quality of the release of post scanners operative minimally invasive arthrodesis\n\nSecondary Objectives: Assessment rates/types of early complications of technical Minimally invasive - early postoperative results (postoperative pain, analgesic consumption, length of hospital stay, blood loss) - in clinical outcomes in the short and medium term decompression after minimally invasive fusion.', 'detailedDescription': 'I. Background / Rationale\n\nFor twenty years, as for other surgical disciplines, new minimally invasive techniques have been developed with the main goal the reduction of muscle trauma associated with the surrounding roads "classic" and reduce morbidity linked to this one.\n\nMore recently, minimally invasive methods dedicated to spinal surgery were established, for the treatment of herniated discs initially, then for narrow lumbar canals.\n\nThe canal release on minimally invasive fusion, using a tubular system for muscle retraction is a new technique that has proven effective: post operative pain reduction of hospital stay and blood loss.\n\nThe objective of the study is to investigate the quality of ductal release in these minimally invasive fusions.\n\nII. objectives\n\nat. primary objective\n\nEvaluating the quality of discharge on postoperative scanners minimally invasive fusions.\n\nb. secondary objectives\n\ni. Evaluation of the rate and type of early complications in the minimally invasive technique\n\nii. Evaluation of early postoperative results (postoperative pain, analgesic consumption, length of hospital stay, blood loss)\n\niii. Evaluation of clinical outcomes in the short and medium term decompression after minimally invasive fusion.\n\nIII. Methodology and duration of the research\n\nThis is a retrospective single-center consecutive series multi-operator regarding the evaluation of surgical practice cited in goal.\n\nClinical data were collected prospectively by KEOPS database (SAMIO). All patients included in our study have spinal MRI scanners and pre-operative and post-operative scans.\n\nN = (number of patients and over what period) / Time Study?\n\nThe series of patients will be classified into two groups:\n\n* Foraminal stenosis\n* Central stenosis\n\nThe evaluation of the primary objective criterion is comparing the height of the foramen measured on CT pre- and post-operative between the lower edge of the overlying pedicle and the top edge of the pedicle underlying the sagittal sections.\n\nFor central stenosis, Postoperative MRI will be performed and the volume of the dural sac will be compared to preoperative MRI on axial images.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to hospital with Paris Saint Joseph with canal compression on one floor, for whom a scan of the spine is performed preoperatively', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ductal compression on one floor\n* Scanner spine preoperatively\n\nExclusion Criteria:\n\n* Spondylolisthesis significant (greater than grade 2)\n* Stenoses multi layered\n* Major spinal deformities'}, 'identificationModule': {'nctId': 'NCT02881593', 'briefTitle': 'Study of the Quality of Post Release on Scanners Operating in Minimally Invasive Arthrodesis', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Study of the Quality of the Release on Postoperative Scanners in Minimally Invasive Arthrodesis', 'orgStudyIdInfo': {'id': 'ARTHROSCAN'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Guillaume P RIOUALLON, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Hôpital Saint-Joseph'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}