Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT03513120
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2018-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Return to Sport After Posterior Spinal Fusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-17', 'studyFirstSubmitDate': '2018-04-19', 'studyFirstSubmitQcDate': '2018-04-19', 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Return to Sport', 'timeFrame': 'Less than 1 year following surgery', 'description': 'Identify at what time patients return to sports without any restrictions.'}], 'secondaryOutcomes': [{'measure': 'Physical Function Levels', 'timeFrame': 'Less than 1 year following surgery', 'description': 'Identify at what time patients report physical function returns to their pre-surgical levels.'}, {'measure': 'Postoperative Complications', 'timeFrame': 'Up to 1 year follow up', 'description': 'Identify any postoperative complications related to release to full activity one month after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adolescent Idiopathic Scoliosis', 'Posterior Spinal Fusion', 'Return to Sport'], 'conditions': ['Adolescent Idiopathic Scoliosis', 'Posterior Spinal Fusion']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this prospective study is to determine when adolescent athletes with idiopathic scoliosis are able to return to sports participation after posterior spinal fusion surgery.', 'detailedDescription': 'The investigators aim to determine at what time subjects return to athletic activity, and how long after surgery they are performing at pre-surgical levels. The investigators will enroll adolescent athletes that meet the inclusion criteria below, and follow their postoperative activity level with standardized activity questionnaires on a monthly basis until the subject reaches their baseline pre-surgical performance level. The investigators primary aim is to determine at what time patients return to sports without any restrictions to contact level or type of play. The investigators secondary aim is to quantitatively assess when patients are able to compete at their prior level of play as determined by self-assessment surveys, as well as identify any post-operative complications in these patients after return to sports.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All enrolled subjects will be competitive athletes with a diagnosis of adolescent idiopathic scoliosis and plans to undergo posterior spinal fusion.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Level of play: high school or club level\n* Frequency of play at above level: \\>3mos/year\n* Age: 10-18 years of age (inclusive)\n* Sports: at least one sport, contact, non-contact, or collision. No sports exclusion criteria\n* Spinal deformity criteria: Adolescent idiopathic scoliosis, curve size 40-75 degrees\n\nExclusion Criteria:\n\n* Play at recreational/intramural level\n* Non-English Speaking Patient\n* Sports participation \\<3 mos/year\n* Non idiopathic etiology or curves \\>75 degrees\n* Treatment outside of Children's Hospital Colorado provider care network"}, 'identificationModule': {'nctId': 'NCT03513120', 'briefTitle': 'Return to Sport After Posterior Spinal Fusion', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Return to Sport After Posterior Spinal Fusion in Adolescent Athletes With Idiopathic Scoliosis: a Prospective Study', 'orgStudyIdInfo': {'id': '17-2473'}}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Sumeet Garg, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Children's Hospital Colorado"}, {'name': 'Allison Tetreault, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD will be shared with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}