Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-09 @ 10:02 AM
Study NCT ID:
NCT02344160
Status:
WITHDRAWN
Last Update Posted:
2016-12-16
First Post:
2015-01-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REDAPT Revision System Study to Assess 5 Year Revision Rate & up to 10 Year Revision Rate and Safety and Effectiveness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018962', 'term': 'Phlebotomy'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Unable to recruit subjects', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-15', 'studyFirstSubmitDate': '2015-01-14', 'studyFirstSubmitQcDate': '2015-01-16', 'lastUpdatePostDateStruct': {'date': '2016-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stem revision', 'timeFrame': '5 years with additional follow up to 10 years', 'description': 'the primary outcome will be assessed by the incidence of stem revision'}], 'secondaryOutcomes': [{'measure': 'Revision for any reason', 'timeFrame': '5 years with additional follow-up to 10 years', 'description': 'Revision for any reason'}, {'measure': 'Radiographic Measurements', 'timeFrame': 'post operatively with additional follow-up to 10 years', 'description': 'radiographic measurements to assess linear radiolucencies and subsidence to assess safety and potential change over time.'}, {'measure': 'Hip Disability and Osteoarthritis Outcome Score (HOOS) and Euro Group Questionnaire (EQ-5D)', 'timeFrame': 'At baseline and up to 10 year follow up', 'description': 'Subject reported outcomes will be collected and scored over time to assess change over time from baseline to 10 year post REDAPT Revision surgery'}, {'measure': 'Harris Hip Score', 'timeFrame': 'at baseline and follow up visits up to 10 year follow up post surgically', 'description': 'Clinical evaluations to score and assess changes over time from baseline to 10 year follow up post REDAPT Revision surgery'}, {'measure': 'Number of participants with Adverse Events', 'timeFrame': 'Adverse events will be collected and assessed as safety out come at each study visit up to 10 years post surgery', 'description': 'Adverse events will be collected to monitor safety'}, {'measure': 'Metal Ion measurement in whole blood', 'timeFrame': 'baseline and at each study visit up to 10 years following REDAPT REvison surgery.', 'description': 'blood will be analysed for metal ion levels at baseline and each study visit up to 10 years to assess change in serum metal ion level over time.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Total Hip Arthroplasty', 'THA'], 'conditions': ['Total Hip Arthroplasty (THA)']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to demonstrate non-inferiority of stem revision rate in subjects implanted with the REDAPT™ System with a revision rate of less than 9.8% at the 5 year mark assuming an observed rate of 6.5% at 5 years. Additional data will be collected as outcomes of safety and effectiveness data up to 10 years post REDAPT revision surgery.', 'detailedDescription': 'This study is a prospective, multi-center, consecutive series study of subjects treated with REDAPT™. The safety and effectiveness of the REDAPT™ revision stem will be assessed over a maximum of 5 years with additional follow up to 10 years to assess outcomes. The objective of this study is to establish if the REDAPT™ stem revision rate is less than 9.8% at 5 years with an observed rate from literature review of 6.5% at 5 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '340 subjects', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject requires revision hip arthroplasty\n* Subject requires subsequent revision of a joint replacement that involves the insertion, removal and/or replacement of a prosthesis or implant\n* Subjects with inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant\n* Treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques\n* Endoprosthesis, femoral osteotomy, or Girdlestone resection\n* Subject is at least 18 years of age\n* Subject is skeletally mature in Investigators judgment\n* Subject is willing to consent to participate in the study\n* Subject is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, infection, or other conditions that would pose excessive operative risk\n\nExclusion Criteria:\n\n* Known allergies to any components of the devices\n* Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation\n* Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits\n* Subject is facing current or impending incarceration\n* Female subject is of child-bearing age and not using an approved method of contraception\n* Mental or neurological conditions which could impair the subject's ability or willingness to comply with the study\n* Physical conditions or activities which tend to place extreme loads on implants, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities, etc.\n* Skeletal immaturity\n* Subject is severely overweight (BMI \\> 40)"}, 'identificationModule': {'nctId': 'NCT02344160', 'briefTitle': 'REDAPT Revision System Study to Assess 5 Year Revision Rate & up to 10 Year Revision Rate and Safety and Effectiveness', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'A Prospective, Multi-center Consecutive Series Study of Subjects Treated With the REDAPT™ Revision Femoral System', 'orgStudyIdInfo': {'id': '13-4538-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Phlebotomy', 'type': 'OTHER', 'otherNames': ['blood draw'], 'description': 'Phlebotomy will be performed at study follow up visits to obtain blood for metal ion analysis which will monitor levels for safety outcome measures'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Ran Schwarzkopf', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'overallOfficials': [{'name': 'James Waddell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Michaels Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}