The Use of CCK vs PS in Revision TKAs

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT06782295
Phase
PHASE4
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Nov 2025
Primary completion
Jul 1, 2028
Completion
Jul 1, 2038

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Constrained condylar (CCK)
    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.
  • Active Comparator: Posterior Stabilized (PS) bearing
    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.

Primary Outcome Measure

Clinical patient reported outcomes [ Time Frame: 6 weeks post op ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612-

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