The Use of CCK vs PS in Revision TKAs

Phase 4

Not yet recruiting

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

• Registration Number: NCT06782295
• Lead Sponsor: Rush University Medical Center

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.

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 Timeline

• Study First Submitted: 2025-01-03
• Study First Submitted QC: 2025-01-16
• Study First Posted: 2025-01-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27
• Study Start: 2025-07-01
• Primary Completion: 2028-07-01
• Study Completion: 2038-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical patient reported outcomes	20 year post op	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)

Secondary Outcome Measures

Name	Time	Method
Clinical reported outcomes (Koos Jr)	6 weeks to 20 years post op	patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time
Range of motion over time	pre op to 20 years pots op	Patients will have their knee range of motion (ROM) checked prior to revision surgery and at multiple timepoints after surgery
Clinical reported outcomes ( VR-12)	6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op	patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time
Clinical reported outcomes ( Forgotten Joint Score)	6 weeks to 20 years post op	patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time
Clinical reported outcomes (EQ-5D-3L)	6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op	patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States