About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients between 18-80 years of age
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
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)
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.
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Constrained Condylar bearing
DevicePatients in this intervention will receive a CCK bearing component
posterior stabilized bearing
DevicePatients in this intervention will receive a PS bearing component
Treatment groups
Trial outcomes
Primary outcomes
Clinical patient reported outcomes
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)
Clinical patient reported outcomes
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)
Clinical patient reported outcomes
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)
Clinical patient reported outcomes
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)
Secondary outcomes
Clinical reported outcomes (Koos Jr)
patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time
Range of motion over time
Patients will have their knee range of motion (ROM) checked prior to revision surgery and at multiple timepoints after surgery
Clinical reported outcomes ( VR-12)
patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time
Clinical reported outcomes ( Forgotten Joint Score)
patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time
Sponsors and contacts
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