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NCT06782295 | NOT YET RECRUITING | Aseptic Loosening of Prosthetic Joint

The Use of CCK vs PS in Revision TKAs
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.

Condition or disease

Aseptic Loosening of Prosthetic Joint

Instability of Prosthetic Joint

Reimplantation for Periprosthetic Joint Infection

Femoral Revision Indicated

Tibial Component Revision

Intervention/treatment

Constrained Condylar bearing

posterior stabilized bearing

Phase

PHASE4

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
Estimated Enrollment : 170 participants
Masking : NONE
Masking Description : only the patient is blinded ahead of time
Primary Purpose : TREATMENT
Official Title : A Prospective Randomized Controlled Trial Comparing Constrained Condylar vs Posterior Stabilized Articulations in Revision Total Knee Arthroplasty
Actual Study Start Date : 2025-07-01
Estimated Primary Completion Date : 2028-07-01
Estimated Study Completion Date : 2038-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
      • -
    The Use of CCK vs PS in Revision TKAs

    Location Details

    NCT06782295

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Not yet recruiting

    United States, Illinois

    Rush University Medical Center

    Chicago, Illinois, United States, 60612