Rush University Medical Center
Chicago, Illinois, 60612, United States
Location status: Recruiting
NCT Number: NCT06782295
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Chicago, Illinois, 60612, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients 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,
Patients undergoing rTKA for bearing exchange only rTKA, isolated tibial component rTKA
Patients 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.
-
Patients in this intervention will receive a CCK bearing component
Other names: CCK
Patients in this intervention will receive a PS bearing component
Time frame: 6 weeks post op
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)
Time frame: 1 year post op
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)
Time frame: 2 year post op
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)
Time frame: 5 year post op
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)
Time frame: 10 year post op
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)
Time frame: 20 year post op
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)
Time frame: 6 weeks to 20 years post op
patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time
Time frame: pre op to 20 years pots op
Patients will have their knee range of motion (ROM) checked prior to revision surgery and at multiple timepoints after surgery
Time frame: 6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op
patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time
Time frame: 6 weeks to 20 years post op
patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time
Time frame: 6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op
patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time
Contact information is provided by the study sponsor or research team.
Anne DeBenedetti, MSc
CONTACT
Omary Behery, MD
CONTACT
Rush University Medical Center
Other
A Prospective Randomized Controlled Trial Comparing Constrained Condylar vs Posterior Stabilized Articulations in Revision Total Knee Arthroplasty
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07653295
Aseptic Loosening of Prosthetic Joint, Fractures, Bone
Balıkesir, Turkey (Türkiye)
View Trial DetailsNCT06839807
Aseptic Loosening, Aseptic Loosening of Orthopaedic Hardware
Nijmegen, Gelderland, Netherlands
View Trial DetailsNCT06724094
Aseptic Loosening of Prosthetic Joint
View Trial DetailsNCT04833634
Aseptic Loosening of Prosthetic Joint, Periprosthetic Fracture Around Prosthetic Joint Implant
Bad Mergentheim, Germany
View Trial Details