The Use of CCK vs PS in Revision TKAs
Launched by RUSH UNIVERSITY MEDICAL CENTER · Jan 16, 2025
Trial Information
Current as of July 01, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of two different types of knee implants—Constrained Condylar (CCK) and Posterior Stabilized (PS)—on patient satisfaction and surgical outcomes in people who need a revision total knee arthroplasty (TKA). This procedure is necessary for patients who have issues like loosening of the joint, instability, or infections related to their knee replacements. The goal is to see which implant type works better in the long run for patients who have had previous knee surgeries.
To participate in this study, individuals must be between 18 and 80 years old and are scheduled for specific types of knee revisions. This includes those needing both the femoral (thigh bone) and tibial (shin bone) parts of their knee replaced, or just the femoral part if the tibial part is suitable for either implant type. Participants will be monitored for their recovery and satisfaction after the surgery. It's important to know that individuals over 80, those who have had knee surgery less than six weeks prior, or those who need certain other types of knee repairs won't be eligible for the trial.
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • 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.
- * 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):
- • Zimmer Biomet Persona, NexGen, or Vanguard
- • Smith and Nephew Legion
- • DJO / Enovis Empowr
- • Stryker Triathlon
- • Link SymphoKnee
- * Depuy Attune sion 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.
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About Rush University Medical Center
Rush University Medical Center is a leading academic medical institution located in Chicago, Illinois, dedicated to advancing healthcare through innovative research and clinical trials. As a sponsor of numerous clinical studies, Rush focuses on translating scientific discoveries into effective treatments and improving patient outcomes across a variety of medical disciplines. With a commitment to excellence in patient care, education, and research, Rush leverages its state-of-the-art facilities and a robust network of specialists to conduct comprehensive trials that adhere to the highest ethical and regulatory standards. Through collaboration with a diverse patient population, Rush aims to enhance the understanding of diseases and develop novel therapeutic strategies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported