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Recruiting NCT06782295

The Use of CCK vs PS in Revision TKAs

Phase IV Interventional Aseptic Loosening of Prosthetic Joint Instability of Prosthetic Joint Reimplantation for Periprosthetic Joint Infection Femoral Revision Indicated

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Constrained Condylar bearing, posterior stabilized bearing.
Who it may be relevant to
Registry conditions: Aseptic Loosening of Prosthetic Joint, Instability of Prosthetic Joint, Reimplantation for Periprosthetic Joint Infection, Femoral Revision Indicated. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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.

Interventions

  • Device Constrained Condylar bearing
    Patients in this intervention will receive a CCK bearing component
  • Device posterior stabilized bearing
    Patients in this intervention will receive a PS bearing component

Primary outcome measures

  • Clinical patient reported outcomes [Time frame: 6 weeks post op]
  • Clinical patient reported outcomes [Time frame: 1 year post op]
  • Clinical patient reported outcomes [Time frame: 2 year post op]
  • Clinical patient reported outcomes [Time frame: 5 year post op]
  • Clinical patient reported outcomes [Time frame: 10 year post op]
  • Clinical patient reported outcomes [Time frame: 20 year post op]
Secondary outcome measures (5)
  • Clinical reported outcomes (Koos Jr) [Time frame: 6 weeks to 20 years post op]
  • Range of motion over time [Time frame: pre op to 20 years pots op]
  • Clinical reported outcomes ( VR-12) [Time frame: 6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op]
  • Clinical reported outcomes ( Forgotten Joint Score) [Time frame: 6 weeks to 20 years post op]
  • Clinical reported outcomes (EQ-5D-3L) [Time frame: 6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op]

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.

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Rush University Medical Center — Chicago

Identifiers

NCT: NCT06782295 · 25010208

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗