Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 8:28 PM
Study NCT ID:
NCT02338661
Status:
COMPLETED
Last Update Posted:
2018-05-01
First Post:
2014-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Observation Study With the SBG Stem
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': 148}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2014-12-12', 'studyFirstSubmitQcDate': '2015-01-09', 'lastUpdatePostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Harris Hip Score', 'timeFrame': 'Baseline and 10 years post surgery', 'description': 'Change in Harris Hip Score from Baseline to 10 years post surgery. The Harris Hip Score scales from 0-100 with higher values representing a better score.'}], 'secondaryOutcomes': [{'measure': 'Assessment of position of hip stem', 'timeFrame': 'Baseline and 10 years post surgery', 'description': 'Change in hip stem position from Baseline to 10 years post surgery.'}, {'measure': 'Radiographic Analysis: classification of osseointegration of hip stem', 'timeFrame': '10 years post surgery'}, {'measure': 'Radiographic Analysis: radiolucent lines around hip stem', 'timeFrame': '10 years post surgery', 'description': 'Radiographic measurements will be taken of linear radiolucencies. Radiolucent lines will be measured in mm.'}, {'measure': 'Radiographic Analysis: number of participants with femoral osteolysis around hip stem', 'timeFrame': '10 years post surgery'}, {'measure': 'Radiographic Analysis: bone atrophy around hip stem', 'timeFrame': '10 years post surgery', 'description': 'Radiographic measurements will be taken of bone atrophy. Bone atrophy will be measured in mm.'}, {'measure': 'Radiographic Analysis: bone hypertrophy around hip stem', 'timeFrame': '10 years post surgery', 'description': 'Radiographic measurements will be taken of bone hypertrophy. Bone hypertrophy will be measured in mm.'}]}, 'conditionsModule': {'conditions': ['Arthroplasty, Hip Replacement']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, single-center, postmarket clinical observation to observe the clinical and radiographic long-term performance of the SBG hip stem.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients requiring the implantation of the SBG hip stem\n\nExclusion Criteria:\n\n* general medical contraindications to surgery\n* acute or recent infection of joint\n* atrophy or deformation of upper femur\n* muscular atrophy or neuromuscular disease\n* pathologic fractures\n* per- and subtrochanteric fractures\n* revision of failed hip endoprosthesis\n* hypersensitivity to used materials\n* any conditions preventing stable anchoring of the hip prosthesis'}, 'identificationModule': {'nctId': 'NCT02338661', 'briefTitle': 'Clinical Observation Study With the SBG Stem', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'Clinical Observation Study With the SBG Stem', 'orgStudyIdInfo': {'id': 'D8319'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SBG hip stem', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buchs', 'country': 'Switzerland', 'facility': 'Praxis Klinik Gut Buchs', 'geoPoint': {'lat': 47.16743, 'lon': 9.47794}}], 'overallOfficials': [{'name': 'Beat Schmid, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Praxis Klinik Gut Buchs'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew Orthopaedics AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}