Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-04-21 @ 8:43 PM
Study NCT ID:
NCT03081260
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2017-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Evaluation Protocol (12 Months Postoperative) of Total Knee Prostheses Anatomic With Resurfaced Patella Versus Non-resurfaced Patella in Patients Requiring Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092462', 'term': 'Patella Fracture'}], 'ancestors': [{'id': 'D000092443', 'term': 'Knee Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2017-03-09', 'studyFirstSubmitQcDate': '2017-03-09', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measure of International Knee Society score (IKS score)', 'timeFrame': '12 months after surgery', 'description': 'The comparison of the IKS (International Knee Society) scores (2011 version) will be done between both groups.'}], 'secondaryOutcomes': [{'measure': 'abnormality of the patellar stroke', 'timeFrame': '12 months after surgery', 'description': 'Presence of an abnormality of the patellar stroke with the type of tilting, subluxation or dislocation of the patella on the X-ray images.'}, {'measure': 'Measure of the forgotten joint score', 'timeFrame': '12 months after surgery', 'description': 'The comparison of the forgotten joint score will be done between both groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Knee Arthroplasty', 'Patella', 'Resurfacing', 'IKS score'], 'conditions': ['Arthroplasty']}, 'referencesModule': {'references': [{'pmid': '33661323', 'type': 'RESULT', 'citation': 'Deroche E, Batailler C, Swan J, Sappey-Marinier E, Neyret P, Servien E, Lustig S. No difference between resurfaced and non-resurfaced patellae with a modern prosthesis design: a prospective randomized study of 250 total knee arthroplasties. Knee Surg Sports Traumatol Arthrosc. 2022 Mar;30(3):1025-1038. doi: 10.1007/s00167-021-06521-y. Epub 2021 Mar 4.'}]}, 'descriptionModule': {'briefSummary': 'Total knee arthroplasty is a frequent surgery in France. It currently represents 70,000 interventions per year. The total knee prosthesis is also called tri-compartmental because it allows articulation between the femur and the tibia but also between the femur and the patella.\n\nThe patella belongs to the extensor system. It articulates with the femoral trochlea in which it slides. It has an important biomechanical role on the quadriceps strength in addition to allowing flexion-extension movements.\n\nIn the case of resurfacing, the joint face of the patella is cut off; A convex polyethylene implant is sealed with cement using studs on the same face.\n\nIn case of non-resurfacing, the surgeon leaves in place the cartilage of the patella which will be in direct contact with the femoral prosthetic trochlea.\n\nBoth methods have advantages and disadvantages. For some implants, it is recommended to resurface the patella because the implant is not very tolerant with the native patella. Other implants have been designed to be better adapted to the preservation of patellar cartilage.\n\nThere is currently no evidence that one method is superior to the other on new generation implants known as "patellar friendly".\n\nIt seems necessary to compare both methods in terms of long-term postsurgery results.', 'detailedDescription': 'The analysis of the primary endpoint (International Knee Society score (IKS score)) will be based on the assumption that the postsurgery score will be identical in both groups. The t test for independent samples will be used to test this hypothesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female (age ≥ 18 years)\n* Diagnosis of knee arthrosis (internal femoro-tibial arthrosis, external femorotibial osteoarthritis, femoro-patellar arthrosis)\n* Indication of total first-line knee arthroplasty\n\nExclusion Criteria:\n\n* Patient whose surgical complexity requires the placement of a strained prosthesis (ligament laxity, bone loss).\n* Refusal to participate in the study\n* Pregnant women, parturients or nursing mothers\n* Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care, persons admitted to a health or social institution for purposes other than research\n* Minor Patients\n* Major persons who are subject to a legal protection measure or are unable to express their consent\n* Patient not affiliated to a social security scheme\n* Patient participating in other interventional research excluding routine care studies not interfering with analysis of primary endpoint'}, 'identificationModule': {'nctId': 'NCT03081260', 'briefTitle': 'Long-term Evaluation Protocol (12 Months Postoperative) of Total Knee Prostheses Anatomic With Resurfaced Patella Versus Non-resurfaced Patella in Patients Requiring Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Long-term Evaluation Protocol (12 Months Postoperative) of Total Knee Prostheses Anatomic With Resurfaced Patella Versus Non-resurfaced Patella in Patients Requiring Total Knee Arthroplasty Prospective, Monocentric, Randomized, Open-label Study', 'orgStudyIdInfo': {'id': '69HCL16_0645'}, 'secondaryIdInfos': [{'id': '2016-A01697-44', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patellar resurfacing', 'description': 'Patellar resurfacing during the total knee prosthesis Anatomic surgery', 'interventionNames': ['Other: Patellar resurfacing']}, {'type': 'OTHER', 'label': 'Patellar non-resurfacing', 'description': 'Patellar non-resurfacing during the total knee prosthesis Anatomic surgery', 'interventionNames': ['Other: Patellar non-resurfacing']}], 'interventions': [{'name': 'Patellar resurfacing', 'type': 'OTHER', 'description': 'The resurfacing of the patella is generally done at the end of the surgery, after having ejected the patella. A frontal bone cut is made using a dedicated ancillary to remove the entire cartilage. Orifices are then made in the patella so that the polyethylene implant can be accommodated with studs which will be cemented on the joint face of the ball joint.', 'armGroupLabels': ['Patellar resurfacing']}, {'name': 'Patellar non-resurfacing', 'type': 'OTHER', 'description': 'Non-resurfacing of the patella does not involve any additional surgical action', 'armGroupLabels': ['Patellar non-resurfacing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital de la Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Sebastien Lustig, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital de la Croix-Rousse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}