Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT06389435
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2024-04-26', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Forgotten Joint Score (FJS)', 'timeFrame': '24 months post surgery', 'description': "The primary outcome measurement will be the Forgotten Joint Score (FJS), measured at 24 months post-surgery. The FJS evaluates the patient's ability to 'forget' the artificial joint in their daily life. This scale ranges from 0 to 100, where 0 represents the maximum joint awareness and 100 represents complete joint unawareness, indicating that the patient does not perceive the joint during daily activities. Higher scores indicate a better outcome, reflecting the success of the knee replacement surgery in restoring natural joint function such that the joint feels like a natural part of the body."}], 'secondaryOutcomes': [{'measure': 'KOOS', 'timeFrame': 'preop, 6 weeks, 12 and 24 months post surgery', 'description': "The secondary outcome measure will include the Knee Injury and Osteoarthritis Outcome Score (KOOS). The KOOS is designed to assess patients' opinions about their knee and associated problems. The score comprises five separately scored subscales: Pain, Other Symptoms, Function in Daily Living (ADL), Function in Sport and Recreation (Sport/Rec), and Knee-Related Quality of Life (QOL). Each subscale is scored from 0 to 100, where 0 represents extreme knee problems and 100 represents no knee problems. Higher scores indicate a better outcome, reflecting fewer symptoms and higher levels of knee function in daily and recreational activities."}, {'measure': 'ADLS knee instability', 'timeFrame': '6 weeks, 12 and 24 months post-operation.', 'description': 'The self reported Activities of Daily Living Scale of the Knee Outcome Survey (ADLS) where participants will rate, over the previous 1-2 days, the degree to which slipping/partial giving way (item 1) and buckling/full giving way (item 2) of each knee affected daily activity graded from 0 (no) to 6 (severe impact on daily living)'}, {'measure': 'The Forgotten Joint Score (FJS)', 'timeFrame': '6 weeks and 12 months post surgery', 'description': "A secondary outcome measurement will be the Forgotten Joint Score (FJS), measured preoperatively, and at 6 weeks and 12 months post-surgery. The FJS evaluates the patient's ability to 'forget' the artificial joint in their daily life. This scale ranges from 0 to 100, where 0 represents the maximum joint awareness and 100 represents complete joint unawareness, indicating that the patient does not perceive the joint during daily activities. Higher scores indicate a better outcome, reflecting the success of the knee replacement surgery in restoring natural joint function such that the joint feels like a natural part of the body."}, {'measure': 'EQ-5D', 'timeFrame': '6 weeks, 12 and 24 months post surgery', 'description': 'A secondary outcome measure will be the European Quality of Life-5 Dimensions (EQ-5D). The EQ-5D is a standardized instrument used to measure health-related quality of life that can be utilized in a wide range of health conditions and treatments. This tool includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three levels: no problems, some problems, and extreme problems. The EQ-5D index is calculated by applying a formula that attaches values to each of the levels in each dimension. This index can range from -0.594 to 1.0, where 1.0 indicates the best health state, 0 represents death, and negative values represent health states perceived as worse than death.'}, {'measure': 'Knee alignment', 'timeFrame': '6 weeks post surgery', 'description': 'Knee alignment measured with long standing x-ray'}, {'measure': 'Adverse events', 'timeFrame': 'up to 24 months post surgery', 'description': 'Adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee arthroplasty', 'Robotic assisted', 'Osteoartritis'], 'conditions': ['Knee Arthroplasty, Total', 'Robotic-assisted', 'Osteoarthritis of the Knee']}, 'descriptionModule': {'briefSummary': 'Rationale for conducting the study:\n\nThe study aims to systematically evaluate the clinical and economic impacts of Robotic-Assisted Total Knee Replacement (RTKR) compared to conventional Total Knee Replacement (TKR). It focuses on the potential benefits of RTKR, including improved precision in surgery, potentially leading to better patient outcomes and reduced healthcare costs. Our primary endpoint is the Forgotten Joint Score (FJS), aimed at measuring patients awareness of their knee joint in everyday life, indicating the success of the knee replacement surgery in restoring natural joint function. Secondary endpoints include patient-reported outcome measures (PROMs), patient activity levels, the accuracy of implant positioning on x-ray, and the incidence of adverse events.\n\nStudy design:\n\nMulticentre,, preference-tolerant, randomized, controlled, superiority trial with two treatment arms that compares the outcomes of RTKR with traditional TKR techniques.\n\nStudy population:\n\nAdult patients aged 18 years and older who are eligible for TKR as per local guidelines and who have given informed consent to participate in the study.\n\nNumber of patients:\n\n400\n\nInclusion criteria:\n\nPatients must be adults aged 18 years and older, eligible for TKR according to local guidelines, and willing to participate in the study.\n\nExclusion criteria:\n\nPatients with extreme malalignment requiring special implants or techniques, patients unfit for surgery due to medical reasons, and those deemed unsuitable to participate in the study for other reasons.\n\nPrimary outcome variables:\n\nThe Forgotten Joint Score (FJS) at 2 years after surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18 years and older.\n* Eligible for TKR according to local guidelines and routines.\n* Willingness to participate in the study.\n\nExclusion Criteria:\n\n* Patients with extreme malalignment necessitating special implants or techniques.\n* Patients unfit for surgery due to other medical reasons.\n* Patients who, for other reason such as alcohol or substance abuse, is deemed unsuitable to participate in the study.\n* Patients who, for other reasons can't fulfill the required patient recorded outcome measures"}, 'identificationModule': {'nctId': 'NCT06389435', 'acronym': 'ROCKETS', 'briefTitle': 'RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Danderyd Hospital'}, 'officialTitle': 'ROCKETS: RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques in a Randomized, Multicenter, Preference-tolerant Study', 'orgStudyIdInfo': {'id': '2024DS'}, 'secondaryIdInfos': [{'id': 'Knee', 'type': 'OTHER', 'domain': 'Danderyds sjukhus'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RTKR', 'description': 'Robotic assisted total knee replacement (RTKR)', 'interventionNames': ['Procedure: Patients will be randomized to undergo TKR or RTKR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TKR', 'description': 'Standard total knee replacement (TKR)', 'interventionNames': ['Procedure: Patients will be randomized to undergo TKR or RTKR']}], 'interventions': [{'name': 'Patients will be randomized to undergo TKR or RTKR', 'type': 'PROCEDURE', 'description': 'Total knee replacement (control group)', 'armGroupLabels': ['RTKR', 'TKR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18288', 'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Olof Skoldenberg, Md, PhD', 'role': 'CONTACT', 'email': 'olof.skoldenberg@ki.se', 'phone': '800-555-5555'}, {'name': 'Olof Skoldenberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Karl Erikson, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Danderyds Sjukhus', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Olof Sköldenberg, MD, PhD', 'role': 'CONTACT', 'email': 'olof.skoldenberg@ki.se', 'phone': '46+700891253'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danderyd Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}, {'name': 'Stockholm South General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Olof Skoldenberg', 'investigatorAffiliation': 'Danderyd Hospital'}}}}