The Use of CCK vs PS in Revision TKAs

NCT06782295 | Recruiting Phase 4 FDA Device

• 1 other identifier: 25010208
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Aseptic Loosening of Prosthetic Joint; Instability of Prosthetic Joint; Reimplantation for Periprosthetic Joint Infection; Femoral Revision Indicated; Tibial Component Revision

Keywords

revision total knee replacement; cck; ps; coronal instability; sagittal instability

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Clinical reported outcomes (Koos Jr)

  6 weeks to 20 years post op

• Range of motion over time

  pre op to 20 years pots op

• Clinical reported outcomes ( VR-12)

  6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op

• Clinical reported outcomes ( Forgotten Joint Score)

  6 weeks to 20 years post op

• Clinical reported outcomes (EQ-5D-3L)

  6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op

Study Arms (2)

Constrained condylar (CCK)

ACTIVE COMPARATOR

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

Posterior Stabilized (PS) bearing

ACTIVE COMPARATOR

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

Interventions

Constrained Condylar bearing DEVICE

Patients in this intervention will receive a CCK bearing component

Also known as: CCK

Constrained condylar (CCK)

posterior stabilized bearing DEVICE

Patients in this intervention will receive a PS bearing component

Posterior Stabilized (PS) bearing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Central Study Contacts

Omary Behery, MD

CONTACT

630-339-2230; omar.behery@rushortho.com

Anne DeBenedetti, MSc

CONTACT

312-432-2468; anne.debenedetti@rushortho.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: only the patient is blinded ahead of time
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Randomized controlled trial with two groups: constrained condylar (CCK) vs posterior stabilized (PS) articulating bearings. These are standard bearings used in revision knees, comparing two types.

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2038
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)