Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT04541693
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-15
First Post:
2020-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
REDAPT Revision Hip System With RSA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2020-08-31', 'studyFirstSubmitQcDate': '2020-09-04', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in RSA Migrations from baseline(2-week) to 6-month, 1-year and 2-year', 'timeFrame': 'Post-op: 2-week, 6-month, 1-year, 2-year', 'description': 'Stability over a period of two year measured by migration with Röntgen Stereometric Analysis'}, {'measure': 'Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year', 'timeFrame': 'Pre-op, Post-op (6 months, 1 year, and 2 years)', 'description': 'The Oxford Hip Score (OHS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OHS measures pain and general activities of daily living.'}, {'measure': 'Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year', 'timeFrame': 'Pre-op, Post-op (6 months, 1 year, and 2 years)', 'description': 'The EuroQol 5D 5L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.'}, {'measure': 'Change is Pain VAS from baseline(pre-op) to 6-month, 1-year and 2-year', 'timeFrame': 'Pre-op, Post-op (6 months, 1 year, and 2 years)', 'description': 'Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (No pain) - 100 (Worst pain imaginable)'}, {'measure': 'Changes in Patient Satisfaction (Likert scale) from baseline(pre-op) to 6-month, 1-year and 2-year', 'timeFrame': 'Pre-op, Post-op (6 months, 1 year, and 2 years)', 'description': 'Patient satisfaction with their hip surgery will be assessed using a 5-point Likert scale: Very Unsatisfied (1), Unsatisfied (2), Neutral (3), Satisfied (4), and Very Satisfied (5).'}], 'secondaryOutcomes': [{'measure': 'Stem subsidence', 'timeFrame': '1-year, 2-year', 'description': 'Comparing RSA exams at the specified time points to determine relative movement of the REDAPT hip stem'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hip Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The principal objectives of the study are to evaluate early and mid-term fixation of the REDAPT revision hip stem and acetabular cup as measured by stem subsidence and proximal cup migration at 2 and 5 years post-surgery through model-based RSA. Secondary objectives include; evaluate the progression of migration between 1 and 2 years and between 2 and 5 years, assess pre- to post-surgery patient improvement in function and health status, evaluate femoral and acetabular radiolucency at 2 and 5 years, and assess patterns of stem migrate on for different revision scenarios (preservation of the trochanters and extended trochanteric osteotomy).', 'detailedDescription': 'This is a prospective, single arm, consecutive series study of patients undergoing revision hip arthroplasty. Patients will be grouped based on the revision implants they receive during surgery. Patients who receive a full hip revision (stem and cup), will be counted in both study groups. The two study groups are:\n\n1. femoral stem revision (n=30 hips)\n2. acetabular cup revision (n=22 hips)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients needing revision hip arthroplasty in which either the femoral stem or the acetabular cup, or both components, will be revised\n* Ability to use study device (not requiring specialized implants)\n* Patients between the ages of 18+ older\n* Patients willing and able to comply with follow-up requirements and self-evaluations\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* Acute infection requiring washout, debridement, and liner exchange\n* Unresolved infection\n* Undergoing stage 1 of a 2-stage revision for infection\n* Known metal allergy to device components\n* Active participation in another clinical study (within the past 30 days)\n* Known risk for loss to follow-up (significant geographical distance from treatment centre)\n* BMI\\>40 (severe obesity)\n* Unable to provide informed consent (cognitive impairment)\n* Patients requiring a bearing couple different than metal on polyethylene\n* Patients requiring extreme distal press-fit revision stems (greater than 240 mm in length)\n* Patients with severe defects, dysplasia, or tumor\n* Inflammatory joint disease'}, 'identificationModule': {'nctId': 'NCT04541693', 'briefTitle': 'REDAPT Revision Hip System With RSA', 'organization': {'class': 'OTHER', 'fullName': 'Orthopaedic Innovation Centre'}, 'officialTitle': 'Early Stability Assessment of the REDAPT Revision Hip System With Radiostereometric Analysis', 'orgStudyIdInfo': {'id': 'B2018-092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Hip revision', 'description': 'Revision to cup and stem, cup only or stem only.', 'interventionNames': ['Device: Full revision', 'Device: Cup revision', 'Device: Stem revision']}], 'interventions': [{'name': 'Full revision', 'type': 'DEVICE', 'description': 'Both cup and stem require revision', 'armGroupLabels': ['Hip revision']}, {'name': 'Cup revision', 'type': 'DEVICE', 'description': 'Only the cup requires revision', 'armGroupLabels': ['Hip revision']}, {'name': 'Stem revision', 'type': 'DEVICE', 'description': 'Only the stem requires revision', 'armGroupLabels': ['Hip revision']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R2K 3S8', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Concordia Hospital', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Thomas Turgeon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Concordia Joint Replacement Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orthopaedic Innovation Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}