Ignite Creation Date:
2025-12-24 @ 1:34 PM
Ignite Modification Date:
2025-12-28 @ 3:11 AM
Study NCT ID:
NCT06782295
Status:
RECRUITING
Last Update Posted:
2025-11-14
First Post:
2025-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of CCK vs PS in Revision TKAs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'only the patient is blinded ahead of time'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial with two groups: constrained condylar (CCK) vs posterior stabilized (PS) articulating bearings. These are standard bearings used in revision knees, comparing two types.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2038-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-01-03', 'studyFirstSubmitQcDate': '2025-01-16', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical patient reported outcomes', 'timeFrame': '6 weeks post op', 'description': 'patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)'}, {'measure': 'Clinical patient reported outcomes', 'timeFrame': '1 year post op', 'description': 'Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)'}, {'measure': 'Clinical patient reported outcomes', 'timeFrame': '2 year post op', 'description': 'Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)'}, {'measure': 'Clinical patient reported outcomes', 'timeFrame': '5 year post op', 'description': 'Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)'}, {'measure': 'Clinical patient reported outcomes', 'timeFrame': '10 year post op', 'description': 'Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)'}, {'measure': 'Clinical patient reported outcomes', 'timeFrame': '20 year post op', 'description': 'Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)'}], 'secondaryOutcomes': [{'measure': 'Clinical reported outcomes (Koos Jr)', 'timeFrame': '6 weeks to 20 years post op', 'description': 'patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time'}, {'measure': 'Range of motion over time', 'timeFrame': 'pre op to 20 years pots op', 'description': 'Patients will have their knee range of motion (ROM) checked prior to revision surgery and at multiple timepoints after surgery'}, {'measure': 'Clinical reported outcomes ( VR-12)', 'timeFrame': '6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op', 'description': 'patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time'}, {'measure': 'Clinical reported outcomes ( Forgotten Joint Score)', 'timeFrame': '6 weeks to 20 years post op', 'description': 'patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time'}, {'measure': 'Clinical reported outcomes (EQ-5D-3L)', 'timeFrame': '6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op', 'description': 'patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['revision total knee replacement', 'cck', 'ps', 'coronal instability', 'sagittal instability'], 'conditions': ['Aseptic Loosening of Prosthetic Joint', 'Instability of Prosthetic Joint', 'Reimplantation for Periprosthetic Joint Infection', 'Femoral Revision Indicated', 'Tibial Component Revision']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the clinical impact of Constrained Condylar versus Posterior Stabilized Knee (PS) bearings on patient satisfaction and surgical outcomes including mid-term survivorship among patients undergoing revision total knee arthroplasty.', 'detailedDescription': 'The primary purpose of this study is to determine whether a difference exists in clinical patient reported outcomes between CCK or PS bearings following rTKA. A secondary goal of the study is to compare both bearings in survivorship free of revision surgery as well as other surgical complications including instability, in early to mid-term follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients between 18-80 years of age\n* Patients who are undergoing both femoral and tibial component revisions, or isolated femoral component revisions with a retained tibial component that is compatible with PS or CCK bearings\n* Patients who are at least 6-weeks out from primary TKA surgery, with complete pre-operative and post-operative knee radiographs obtained at standard of care perioperative visits (AP/lateral and patellar views)\n* Patients undergoing rTKA for indications including aseptic component loosening, flexion or extension coronal or sagittal instability, component malalignment, arthrofibrosis, patellar maltracking, reimplantation following single or two-stage exchange revision for prosthetic joint infection or bearing surface wear when femoral or tibial component revision is indicated.\n* The use of revision total knee arthroplasty systems which have PS and CCK bearing options including different degree options of coronal and rotational constraint (to be individually randomized per constrained option):\n* Zimmer Biomet Persona, NexGen, or Vanguard\n* Smith and Nephew Legion\n* DJO / Enovis Empowr\n* Stryker Triathlon\n* Link SymphoKnee\n* Depuy Attune sion Criteria:\n\nExclusion Criteria:\n\nPatients undergoing rTKA with a hinged implant, or pre-operatively determined to require CCK bearing rTKA, \\> 80 years of age, or those requiring rTKA less than 6-weeks from the primary TKA,\n\nPatients undergoing rTKA for bearing exchange only rTKA, isolated tibial component rTKA\n\nPatients with pre-operative diagnosis of extensor mechanism disruption or collateral ligament incompetence or with a compromised soft tissue envelope requiring pre-pre-operative plastic surgery evaluation and planned soft tissue coverage.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06782295', 'briefTitle': 'The Use of CCK vs PS in Revision TKAs', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'A Prospective Randomized Controlled Trial Comparing Constrained Condylar vs Posterior Stabilized Articulations in Revision Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '25010208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Constrained condylar (CCK)', 'description': "Once patient meets inclusion criteria, they'll be randomized prior to surgery to a specific CCK implant design. All surgeries will be done at the approved hospital or ASC and if the allocated component isn't used, the patient will still be followed post operatively and remain in the study.", 'interventionNames': ['Device: Constrained Condylar bearing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Posterior Stabilized (PS) bearing', 'description': "Once patient meets inclusion criteria, they'll be randomized prior to surgery to a specific PS implant design. All surgeries will be done at the approved hospital or ASC and if the allocated component isn't used, the patient will still be followed post operatively and remain in the study.", 'interventionNames': ['Device: posterior stabilized bearing']}], 'interventions': [{'name': 'Constrained Condylar bearing', 'type': 'DEVICE', 'otherNames': ['CCK'], 'description': 'Patients in this intervention will receive a CCK bearing component', 'armGroupLabels': ['Constrained condylar (CCK)']}, {'name': 'posterior stabilized bearing', 'type': 'DEVICE', 'description': 'Patients in this intervention will receive a PS bearing component', 'armGroupLabels': ['Posterior Stabilized (PS) bearing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Omary Behery, MD', 'role': 'CONTACT', 'email': 'omar.behery@rushortho.com', 'phone': '630-339-2230'}, {'name': 'Anne DeBenedetti, MSc', 'role': 'CONTACT', 'email': 'anne.debenedetti@rushortho.com', 'phone': '312-432-2468'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Omar Behery', 'investigatorAffiliation': 'Rush University Medical Center'}}}}