Recruiting

Constrained Condylar vs. Posterior Stabilized

Sponsor:

Rush University Medical Center

Code:

NCT06782295

Conditions

Aseptic Loosening of Prosthetic Joint

Instability of Prosthetic Joint

Reimplantation for Periprosthetic Joint Infection

Femoral Revision Indicated

Tibial Component Revision

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Constrained Condylar bearing

posterior stabilized bearing

Study Details

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.

Conditions

Aseptic Loosening of Prosthetic Joint

Instability of Prosthetic Joint

Reimplantation for Periprosthetic Joint Infection

Femoral Revision Indicated

Tibial Component Revision

Study ID

NCT06782295

Start date

Jul 1, 2025

Status verified date

Nov, 2025

Completion date

Jul 1, 2038

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

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Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Constrained Condylar bearing

Patients in this intervention will receive a CCK bearing component

posterior stabilized bearing

Patients in this intervention will receive a PS bearing component

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

More Information

Sponsor

Rush University Medical Center

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Keywords

  • revision total knee replacement
  • cck
  • ps
  • coronal instability
  • sagittal instability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2025-11-14.