Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT02540902
Status:
UNKNOWN
Last Update Posted:
2019-05-24
First Post:
2015-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of an All Polyethylene Tibial Component
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-22', 'studyFirstSubmitDate': '2015-08-11', 'studyFirstSubmitQcDate': '2015-09-03', 'lastUpdatePostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone mineral density', 'timeFrame': '18 to 24 months post-operatively', 'description': 'Measure of peri-prosthetic bone mineral density'}], 'secondaryOutcomes': [{'measure': 'Intra-operative RoM', 'timeFrame': 'Intra-operative', 'description': 'Range of movement of the knee joint measured by the navigation computer during surgery'}, {'measure': 'Intra-operative alignment', 'timeFrame': 'Intra-operative', 'description': 'The leg alignment measured by the navigation computer during surgery.'}, {'measure': 'RoM', 'timeFrame': '1 year', 'description': 'Active range of motion of the knee joint'}, {'measure': 'Oxford Knee Score', 'timeFrame': '1 year', 'description': 'Clinical outcome measure'}, {'measure': 'EQ-5D', 'timeFrame': '1 year', 'description': 'General health measure'}, {'measure': 'Patient satisfaction', 'timeFrame': '1 year', 'description': 'Patient satisfaction with surgery (Scale: 0 to 10, 0 = not satisfied, 10 = very satisfied)'}, {'measure': 'Leg alignment', 'timeFrame': '1 year', 'description': 'Leg alignment measured from long leg x-rays'}, {'measure': 'Bone condition', 'timeFrame': '1 year', 'description': 'Signs of osteolysis from knee x-rays'}, {'measure': 'Complications', 'timeFrame': '1 year', 'description': 'Any post-operative complications as a result of surgery, e.g. infection, revision, aseptic loosening.'}, {'measure': 'Implant survivorship', 'timeFrame': '18 to 24 months', 'description': 'Percentage of implants still in situ over time.'}, {'measure': 'Surgeon feedback from surgery', 'timeFrame': 'intra-operative', 'description': 'Surgeon experience and issues with using all-polyethylene tibia using an un-validated questionnaire.'}, {'measure': 'Component position', 'timeFrame': '1 year', 'description': 'Migration of the component over time measured from x-rays'}, {'measure': 'Peri-prosthetic lucency', 'timeFrame': '1 year', 'description': 'Radiolucent lines (\\>2mm wide) around the component which may indicate component loosening'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Knee replacement', 'Knee arthroplasty', 'All-polyethylene tibia', 'Bone density'], 'conditions': ['Knee Replacement']}, 'descriptionModule': {'briefSummary': 'This will be a prospective single cohort investigation of the Columbus all polyethylene tibia (Aesculap AG, Tuttlingen, Germany) used in total knee arthroplasty (TKA) surgery. The aim of the project is to determine post-operative outcome of the all polyethylene tibia up to two years.', 'detailedDescription': 'Thirty consecutive TKA patients under the care of two orthopaedic consultants at the Golden Jubilee National Hospital who meet the inclusion/exclusion criteria will be recruited to the study and will be given the all polyethylene tibia. Participants will return for their standard postoperative followup appointments (6 weeks and 1 year post-operatively). In addition to standard care, a bone density scan using dual energy x-ray absorptiometery (DXA) will be done as part of the 6 weeks post-operative follow-up. A second DXA scan will be done at an additional appointment at the hospital between 18 and 24 months post-operatively for a bone density scan which is not part of standard care.\n\nThe data which will be analysed will be the results of the bone scan, computer generated data about the range of movement (RoM) and alignment of the operated knee collected as part of the operation, the RoM, clinical outcome and satisfaction data collected at the pre-operative assessment and post-operative followups, pre- and post-operative x-rays, complications, survivorship and surgeon experience of using the all polyethylene tibia. These data will be investigated to see if the all polyethylene tibia has satisfactory outcomes with no adverse effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Unilateral TKA\n2. Aged 70 year or older\n3. BMI \\< 37.5\n4. Suitable to receive the study implant\n\nExclusion Criteria:\n\n1. Revision of existing knee replacement\n2. Previous lower limb replacement\n3. Proximal tibial bone defects\n4. Diagnosed osteopenia or osteoporosis\n5. Unable to give informed consent\n6. Unwilling to take part\n7. Unable to return to the Golden Jubilee National Hospital for followup appointments'}, 'identificationModule': {'nctId': 'NCT02540902', 'briefTitle': 'Study of an All Polyethylene Tibial Component', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Golden Jubilee National Hospital'}, 'officialTitle': 'A Prospective Study of an All Polyethylene Tibial Component Used in Total Knee Arthroplasty Surgery', 'orgStudyIdInfo': {'id': 'Ortho 15-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All-poly', 'description': 'Knee arthroplasty with all-polyethylene tibia', 'interventionNames': ['Device: All-polyethylene tibia (Aesculap AG)']}], 'interventions': [{'name': 'All-polyethylene tibia (Aesculap AG)', 'type': 'DEVICE', 'otherNames': ['Aesculap All Poly Tibia Plateau Columbus CR DD', 'NN1200-NN1203, NN1210-NN1213, NN1220-NN1223', 'NN1230-NN1233, NN1240-NN1243, NN1250-NN1253'], 'description': 'Implantation of an all polyethylene tibial component.', 'armGroupLabels': ['All-poly']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G81 4DY', 'city': 'Clydebank', 'state': 'West Dunbartonshire', 'country': 'United Kingdom', 'facility': 'Golden Jubilee National Hospital', 'geoPoint': {'lat': 55.90137, 'lon': -4.4057}}], 'overallOfficials': [{'name': 'Frederic Picard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Golden Jubilee National Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Golden Jubilee National Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Aesculap AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}