Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
Study NCT ID:
NCT03954912
Status:
COMPLETED
Last Update Posted:
2019-06-20
First Post:
2019-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Outcomes Between Image-based Versus Imageless Robot-assisted Unicondylar Knee Arthroplasty
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective cohort study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-18', 'studyFirstSubmitDate': '2019-05-13', 'studyFirstSubmitQcDate': '2019-05-16', 'lastUpdatePostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'operative time', 'timeFrame': '1 day', 'description': 'operative time in minutes the higher value of blood loss is worse outcome'}, {'measure': 'calculated total blood loss', 'timeFrame': '1 day', 'description': 'total blood loss which was calculated using a formula based on patient blood volume and a decrease in hemoglobin'}], 'secondaryOutcomes': [{'measure': 'post operative complications', 'timeFrame': '12 months', 'description': 'post operative complications included infection, wound complication, stiffness and revision. the higher number of post operative outcome is the worse outcomes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MAKO', 'NAVIO', 'robotic surgery', 'UKA', 'surgical time', 'KSS', 'KFS'], 'conditions': ['Osteoarthritis, Knee', 'Arthropathy of Knee']}, 'referencesModule': {'references': [{'pmid': '32660619', 'type': 'DERIVED', 'citation': 'Leelasestaporn C, Tarnpichprasert T, Arirachakaran A, Kongtharvonskul J. Comparison of 1-year outcomes between MAKO versus NAVIO robot-assisted medial UKA: nonrandomized, prospective, comparative study. Knee Surg Relat Res. 2020 Mar 12;32(1):13. doi: 10.1186/s43019-020-00030-x.'}]}, 'descriptionModule': {'briefSummary': 'This prospective cohort study was conducted with the aim of comparing relevant clinical outcomes which included intra (surgical time and blood loss), post-operative outcomes (range of motion, function, complications and revisions) and return to activity between imageless and image-based surgical system in medial unicondylar knee arthroplasty', 'detailedDescription': 'this prospective cohort study was conducted between 1st June 2015 and 1st July 2018 at Bhumibol Adulyadej Hospital, Bangkok, Thailand. A total of 33 medial compartment OA knee patients were randomly allocated to MAKO or NAVIO robotic assisted UKA. The outcomes assessed were intra-operative outcomes (operative time, blood loss) and postoperative outcomes (function, complications and revision) at 1 year after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients were those deemed suitable for unicondylar knee arthroplasty surgery\n* patients who could give informed consent\n* patients who willing to attend the prescribed follow-up.\n\nExclusion Criteria:\n\n* Patients who have medial osteoarthritis knee with following condition:\n\n 1. Ligament insufficiency (anterior cruciate ligament rupture, collateral ligament insufficiency).\n 2. Inflammatory arthritis\n 3. A deformity requiring augmentation\n 4. Neurological movement disorders\n 5. pathology of the feet, ankles, hips, or opposite knee causing significant pain or gait alterations\n* Patients who ultimately required a total knee arthroplasty (valgus greater than 14 degree, multiple compartment osteoarthritis were contraindications to unicondylar knee arthroplasty.'}, 'identificationModule': {'nctId': 'NCT03954912', 'briefTitle': 'Comparative Outcomes Between Image-based Versus Imageless Robot-assisted Unicondylar Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Ramathibodi Hospital'}, 'officialTitle': 'Comparative Outcomes Between Image-based (MAKO) Versus Imageless NAVIO Robot-assisted Unicondylar Knee Arthroplasty', 'orgStudyIdInfo': {'id': '2/62'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MAKO robotic assisted UKA', 'description': 'image base (MAKO) robotic assisted UKA', 'interventionNames': ['Procedure: MAKO assisted unicondylar knee arthroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NAVIO robotic assisted UKA', 'description': 'imageless (NAVIO) robotic assisted UKA', 'interventionNames': ['Procedure: NAVIO assisted unicondylar knee arthroplasty']}], 'interventions': [{'name': 'MAKO assisted unicondylar knee arthroplasty', 'type': 'PROCEDURE', 'description': 'MAKO assisted', 'armGroupLabels': ['MAKO robotic assisted UKA']}, {'name': 'NAVIO assisted unicondylar knee arthroplasty', 'type': 'PROCEDURE', 'description': 'NAVIO assisted', 'armGroupLabels': ['NAVIO robotic assisted UKA']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramathibodi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bhumibol Adulyadej Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Jatupon Kongtharvonskul', 'investigatorAffiliation': 'Ramathibodi Hospital'}}}}