Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT01220505
Status:
COMPLETED
Last Update Posted:
2019-12-19
First Post:
2010-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}, {'id': 'D007738', 'term': 'Kyphosis'}, {'id': 'D008141', 'term': 'Lordosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-17', 'studyFirstSubmitDate': '2010-10-12', 'studyFirstSubmitQcDate': '2010-10-13', 'lastUpdatePostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maintenance of Deformity Correction', 'timeFrame': '6 months', 'description': 'The primary outcome measure for this trial will be the percentage of subjects who have maintained their degree of deformity correction within 10% from immediate post-op to the 6 month follow-up visit.'}], 'secondaryOutcomes': [{'measure': 'Decreased Operative Time', 'timeFrame': '6 Months', 'description': 'Comparison of Operative times vs. literature'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['scoliosis', 'kyphosis', 'spinal deformity', 'curvature', 'lordosis'], 'conditions': ['Spinal Deformity']}, 'descriptionModule': {'briefSummary': 'The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System \\& Trivium 3D Spinal Deformity Correction System.', 'detailedDescription': 'The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System \\& Trivium 3D Spinal Deformity Correction System. We have extended the study tol collect further outcomes data at the 12 month time point.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects with a spinal defomrity with a Risser score of a minimum of 3 where the physician has determined that the patient requires a spinal fusion of the thoracic or lumbar spine are eligible for entry into the post market surveillance.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 200 subjects at 10 clinical centers.\n* All subjects undergoing spinal fusion surgery between the levels of T1- Ilium (Thoracic 1 to Ilium)\n* All subjects are skeletally mature with spinal deformity.\n* Risser score must be ≥ 3.\n* Subjects or their representative must be willing and able to give informed consent and assent (if applicable).\n* Subjects who do not meet any of the following contraindications: spinal infection or inflammation, morbid obesity, mental illness, alcoholism, drug abuse, pregnancy, metal sensitivity, foreign body sensitivity, patients with inadequate tissue coverage over the operative site, open wounds local to the operative area, any case not described in the specific indications\n\nExclusion Criteria:\n\n* Any subject who does not meet the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT01220505', 'briefTitle': 'Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Post Market Surveillance Validation to Evaluate the Effectiveness of the Following System: Polaris Deformity Spinal System', 'orgStudyIdInfo': {'id': 'CS-058'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Surgery', 'type': 'PROCEDURE', 'otherNames': ['Polaris Deformity Spinal System', 'Trivium Deformtiy Correction System'], 'description': 'All subjects will have spinal surgery between the levels of T1 and Ilium using the Polaris Deformity Spinal System'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Orthopedics for Kids, PC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Orthopedics of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46278', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Orthopedics Indianapolis, P.C.', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48307', 'city': 'Rochester Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Rochester Hills Orthopedics', 'geoPoint': {'lat': 42.65837, 'lon': -83.14993}}, {'zip': '00917', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Torre Auxillo Mutuo', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Tammy Stinson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zimmer Biomet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}