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NCT Number: NCT06782295

The Use of CCK vs PS in Revision TKAs

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Constrained Condylar bearing

Device

Patients in this intervention will receive a CCK bearing component

Other names: CCK

posterior stabilized bearing

Device

Patients in this intervention will receive a PS bearing component

Primary outcomes

  1. Clinical patient reported outcomes

    Time frame: 6 weeks post op

    patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)

  2. Clinical patient reported outcomes

    Time frame: 1 year post op

    Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)

  3. Clinical patient reported outcomes

    Time frame: 2 year post op

    Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)

  4. Clinical patient reported outcomes

    Time frame: 5 year post op

    Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)

  5. Clinical patient reported outcomes

    Time frame: 10 year post op

    Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)

  6. Clinical patient reported outcomes

    Time frame: 20 year post op

    Patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time. The clinical patient reported outcomes of a revision total knee replacement to detect a 6-point difference in knee society score (KSS)

Secondary outcomes

  1. Clinical reported outcomes (Koos Jr)

    Time frame: 6 weeks to 20 years post op

    patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time

  2. Range of motion over time

    Time frame: pre op to 20 years pots op

    Patients will have their knee range of motion (ROM) checked prior to revision surgery and at multiple timepoints after surgery

  3. Clinical reported outcomes ( VR-12)

    Time frame: 6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op

    patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time

  4. Clinical reported outcomes ( Forgotten Joint Score)

    Time frame: 6 weeks to 20 years post op

    patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time

  5. Clinical reported outcomes (EQ-5D-3L)

    Time frame: 6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op

    patients will be asked pre and post operatively to completed standard of care patient reported outcomes to compare over time

Study contacts

Contact information is provided by the study sponsor or research team.

Anne DeBenedetti, MSc

CONTACT

[email protected]

312-432-2468

Omary Behery, MD

CONTACT

[email protected]

630-339-2230

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2038
First posted
Jan 17, 2025
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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