Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-05 @ 9:00 PM
Study NCT ID:
NCT03677518
Status:
COMPLETED
Last Update Posted:
2023-05-17
First Post:
2018-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Knee Arthroplasty With the Medial-Pivot Knee System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-16', 'studyFirstSubmitDate': '2018-09-18', 'studyFirstSubmitQcDate': '2018-09-18', 'lastUpdatePostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flexion with an Advance® Medial-Pivot knee', 'timeFrame': '2years', 'description': 'The objective of this study was to evaluate the flexion in patients with an Advance® Medial-Pivot knee after an average follow-upof 10 years. Knee flexion was measured with a goniometer in the office; thegreater trochanter, knee centre and lateral malleolus were used asreference points.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['total knee arthroplasty', 'medial-pivot knee system', 'kinematics', 'survivorship'], 'conditions': ['Arthroplasty Complications']}, 'descriptionModule': {'briefSummary': 'The "ball-in-socket" design of the Medial-Pivot knee system (MicroPort Orthopedics, Arling-ton, Tennessee, USA) aims to reproduce normal knee kinematics by medializing its rotational axis. Thegoal of this study was to measure knee range of motion (ROM) with this implant after a mean follow-up of 10 years and to report the survivorship and long-term clinical and radiological outcomes. Wehypothesized the prosthetic knee would have at least 120◦flexion at 10 years. This was retrospective, single-centre study of 74 Medial-Pivot knees implanted in71 patients (average age of 69 years) between May 2005 and November 2007. All patients who receiveda Medial-Pivot knee were included consecutively. The mean follow-up was 10 years. Clinical and radio-logical assessments were performed using the Knee Society Score (KSS) and Ewald\'s score. Kaplan-Meirsurvival analysis was used to calculate survivorship.', 'detailedDescription': 'methodsThis was retrospective, single-centre study of 74 Medial-Pivotknees implanted in 71 patients between May 2005 and Novem-ber 2007. During this period, several types of semi-constrainedprimary TKA implants were used.The "ball-in-socket" design of the Medial-Pivot knee system (MicroPort Orthopedics, Arling-ton, Tennessee, USA) aims to reproduce normal knee kinematics by medializing its rotational axis. Thegoal of this study was to measure knee range of motion (ROM) with this implant after a mean follow-up of 10 years and to report the survivorship and long-term clinical and radiological outcomes. Wehypothesized the prosthetic knee would have at least 120◦flexion at 10 years. This was retrospective, single-centre study of 74 Medial-Pivot knees implanted in71 patients (average age of 69 years) between May 2005 and November 2007. All patients who receiveda Medial-Pivot knee were included consecutively. The mean follow-up was 10 years. Clinical and radio-logical assessments were performed using the Knee Society Score (KSS) and Ewald\'s score. Kaplan-Meirsurvival analysis was used to calculate survivorship.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients were operated by four experienced surgeons usingthe same protocol. A mid-line skin incision was made in all patientsexcept one who had previously undergone a lateral osteotomy. The parapatellar arthrotomy was medial in all cases. Independent tibialand femoral cuts were made with an intramedullary femoral aim-ing device targeting 7◦valgus in 48 cases and 5◦in 2 cases. Femoral component external rotation of 3◦relative to the posterior condy-lar plane was applied in all patients. All implants were fixed usingPalacos®bone cement with gentamicin (Haeraus, Warsaw, USA).The patella was resurfaced in 40 knees.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients \\> 18 years\n* patienst must be operated\n* patient with mid-line skin incision\n\nExclusion Criteria:\n\n* patients \\< 18 years'}, 'identificationModule': {'nctId': 'NCT03677518', 'acronym': 'MEDIAL-PIVOT', 'briefTitle': 'Total Knee Arthroplasty With the Medial-Pivot Knee System', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': "Total Knee Arthroplasty With the Medial-Pivot Knee System: Clinicaland Radiological Outcomes at 9.5 Years' Mean Follow-up", 'orgStudyIdInfo': {'id': 'PI2017_843_0052'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Fabrice Mertl, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU AMIENS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}