NCT06782295 The Use of CCK vs PS in Revision TKAs
| NCT ID | NCT06782295 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Rush University Medical Center |
| Condition | Aseptic Loosening of Prosthetic Joint |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 170 participants in total. It began in 2025-07-01 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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. \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06782295 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aseptic Loosening of Prosthetic Joint. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06782295 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06782295 currently recruiting?
Yes, NCT06782295 is actively recruiting participants. Contact the research team at omar.behery@rushortho.com for enrollment information.
Where is the NCT06782295 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06782295 clinical trial?
NCT06782295 is sponsored by Rush University Medical Center. The trial plans to enroll 170 participants.