The Use of CCK vs PS in Revision TKAs
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Rush University Medical Center
- Study ID
- NCT06782295
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Aseptic Loosening of Prosthetic Joint
- Femoral Revision Indicated
- Instability of Prosthetic Joint
- Reimplantation for Periprosthetic Joint Infection
- Tibial Component Revision
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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
Study Details
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.
Key Dates
- Start date
- Jul 1, 2025
- Status verified
- Nov 2025
- Primary completion
- Jul 1, 2028
- Completion
- Jul 1, 2038
Study Design
- Enrollment
- 170 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Constrained condylar (CCK)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.
- Active Comparator: Posterior Stabilized (PS) bearingOnce 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.
Primary Outcome Measure
Clinical patient reported outcomes [ Time Frame: 6 weeks post op ]
Central Contacts
- Omary Behery, MD630-339-2230
- Anne DeBenedetti, MSc312-432-2468
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | - |
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