The Use of CCK vs PS in Revision TKAs

A Prospective Randomized Controlled Trial Comparing Constrained Condylar vs Posterior Stabilized Articulations in Revision Total Knee Arthroplasty

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.

Study Overview

• Status: Recruiting
• Conditions: Instability of Prosthetic Joint; Aseptic Loosening of Prosthetic Joint; Reimplantation for Periprosthetic Joint Infection; Femoral Revision Indicated; Tibial Component Revision
• Intervention / Treatment: Device: Constrained Condylar bearing; Device: posterior stabilized bearing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Anne DeBenedetti, MSc; Phone Number: 312-432-2468; Email: anne.debenedetti@rushortho.com
• Study Contact Backup: Name: Omary Behery, MD; Phone Number: 630-339-2230; Email: omar.behery@rushortho.com

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Constrained Condylar bearing; Patients in this intervention will receive a CCK bearing component; Other Names: CCK
Active Comparator: Posterior Stabilized (PS) bearing; Once 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.	Device: posterior stabilized bearing; Patients in this intervention will receive a PS bearing component

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 weeks post op
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)	1 year post op
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)	2 year post op
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)	5 year post op
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)	10 year post op
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)	20 year post op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 weeks to 20 years post op
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	pre op to 20 years pots op
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	6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op
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	6 weeks to 20 years post op
Clinical reported outcomes (EQ-5D-3L)	patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time	6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2038

Study Registration Dates

• First Submitted: January 3, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): January 17, 2025

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: cck; revision total knee replacement; ps; coronal instability; sagittal instability
• Other Study ID Numbers: 25010208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No