Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-27 @ 3:42 AM
Study NCT ID:
NCT05011734
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2021-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Postoperative Recovery Pathway in Adolescent Idiopathic Scoliosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2021-07-28', 'studyFirstSubmitQcDate': '2021-08-13', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the Fast track protocol', 'timeFrame': 'at baseline (Day0)', 'description': 'Evaluation of an intra- and post-operative fast-track protocol in terms of postoperative pain management.'}, {'measure': 'Evaluation of the Fast track protocol', 'timeFrame': 'at baseline (Day0)', 'description': 'Evaluation of an intra- and post-operative fast-track protocol in terms of duration/times of hospitalization'}, {'measure': 'Evaluation of the Fast track protocol', 'timeFrame': 'at baseline (Day0)', 'description': 'Evaluation of an intra- and post-operative fast-track protocol in terms of blood loss'}, {'measure': 'Evaluation of the Fast track protocol', 'timeFrame': 'at baseline (Day0)', 'description': 'Evaluation of an intra- and post-operative fast-track protocol in terms of patient education in early recovery of function.'}], 'secondaryOutcomes': [{'measure': 'Surgical and clinical outcome', 'timeFrame': 'at baseline (Day0)', 'description': 'evaluation of the hemocytometric examination (performed as per normal clinical practice).'}, {'measure': 'Surgical and clinical outcome', 'timeFrame': 'at baseline (Day0)', 'description': 'evaluation of the main circulating inflammatory mediators.'}, {'measure': 'Surgical and clinical outcome', 'timeFrame': 'at baseline (Day0)', 'description': 'evaluation of culture examinations on the surgical wound drainage fluid and microstructural analysis of the surgical drainage tube by scanning electron microscope.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Scoliosis'], 'conditions': ['Scoliosis Idiopathic']}, 'referencesModule': {'references': [{'pmid': '33098493', 'type': 'RESULT', 'citation': 'Wang H, Tetteroo D, Arts JJC, Markopoulos P, Ito K. Quality of life of adolescent idiopathic scoliosis patients under brace treatment: a brief communication of literature review. Qual Life Res. 2021 Mar;30(3):703-711. doi: 10.1007/s11136-020-02671-7. Epub 2020 Oct 24.'}, {'pmid': '33094437', 'type': 'RESULT', 'citation': 'Lee CS, Merchant S, Chidambaran V. Postoperative Pain Management in Pediatric Spinal Fusion Surgery for Idiopathic Scoliosis. Paediatr Drugs. 2020 Dec;22(6):575-601. doi: 10.1007/s40272-020-00423-1. Epub 2020 Oct 23.'}, {'pmid': '30214945', 'type': 'RESULT', 'citation': 'Seki H, Ideno S, Ishihara T, Watanabe K, Matsumoto M, Morisaki H. Postoperative pain management in patients undergoing posterior spinal fusion for adolescent idiopathic scoliosis: a narrative review. Scoliosis Spinal Disord. 2018 Sep 12;13:17. doi: 10.1186/s13013-018-0165-z. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'the study will evaluate the clinical outcomes of an intra- and postoperative fast-track protocol in patients undergoing instrumented posterior arthrodesis surgery for adolescent idiopathic scoliosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescents with idiopathic scoliosis treatable by surgical procedure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 14-18 years\n* iagnosis of adolescent idiopathic scoliosis requiring an instrumented posterior arthrodesis surgical procedure\n* Males and females.\n\nExclusion Criteria:\n\n* spinal infection\n* neoplastic diseases\n* heart disease\n* hypersensitivity to tranexamic acid\n* history of coagulopathy and/or previous thromboembolic events\n* severe renal failure'}, 'identificationModule': {'nctId': 'NCT05011734', 'briefTitle': 'Rapid Postoperative Recovery Pathway in Adolescent Idiopathic Scoliosis.', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Rapid Postoperative Recovery (Fast-track) Pathway in Adolescent Idiopathic Scoliosis: a Pilot Study', 'orgStudyIdInfo': {'id': 'FAST-TRACK-IOR'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fast Track recovery pathway', 'type': 'OTHER', 'description': 'Multidisciplinary approach alongside the orthopedic surgeon'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'state': 'BO', 'country': 'Italy', 'facility': 'IRCCS Itituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}