The Use of CCK vs PS in Revision TKAs

Phase 4RecruitingNCT06782295

Rush University Medical Center170 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

170

Conditions

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

Interventions

Constrained Condylar bearingDEVICE

Patients in this intervention will receive a CCK bearing component

posterior stabilized bearingDEVICE

Patients in this intervention will receive a PS bearing component

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. \-

Locations (1)

Rush University Medical Center

Chicago, Illinois, United States

RECRUITING