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The Use of CCK vs PS in Revision TKAs

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Status and phase

Not yet enrolling
Phase 4

Conditions

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

Treatments

Device: posterior stabilized bearing
Device: Constrained Condylar bearing

Study type

Interventional

Funder types

Other

Identifiers

NCT06782295
25010208

Details and patient eligibility

About

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.

Full 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.

Enrollment

170 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

170 participants in 2 patient groups

Constrained condylar (CCK)
Active Comparator group
Description:
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.
Treatment:
Device: Constrained Condylar bearing
Posterior Stabilized (PS) bearing
Active Comparator group
Description:
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.
Treatment:
Device: posterior stabilized bearing

Trial contacts and locations

1

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Central trial contact

Anne DeBenedetti, MSc; Omary Behery, MD

Data sourced from clinicaltrials.gov

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