Clinical trial NCT06782295: The Use of CCK vs PS in Revision TKAs
Official title: A Prospective Randomized Controlled Trial Comparing Constrained Condylar vs Posterior Stabilized Articulations in Revision Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Aseptic Loosening of Prosthetic Joint
Instability of Prosthetic Joint
Reimplantation for Periprosthetic Joint Infection
Femoral Revision Indicated
Tibial Component Revision
Keywords: revision total knee replacement
cck
ps
coronal instability
sagittal instability
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with two groups: constrained condylar (CCK) vs posterior stabilized (PS) articulating bearings. These are standard bearings used in revision knees, comparing two types.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

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Primary outcomes:
measure: Clinical patient reported outcomes
timeFrame: 6 weeks post op
measure: Clinical patient reported outcomes
timeFrame: 1 year post op
measure: Clinical patient reported outcomes
timeFrame: 2 year post op
measure: Clinical patient reported outcomes
timeFrame: 5 year post op
measure: Clinical patient reported outcomes
timeFrame: 10 year post op
measure: Clinical patient reported outcomes
timeFrame: 20 year post op
Secondary outcomes:
measure: Clinical reported outcomes (Koos Jr)
timeFrame: 6 weeks to 20 years post op
measure: Range of motion over time
timeFrame: pre op to 20 years pots op
measure: Clinical reported outcomes ( VR-12)
timeFrame: 6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op
measure: Clinical reported outcomes ( Forgotten Joint Score)
timeFrame: 6 weeks to 20 years post op
measure: Clinical reported outcomes (EQ-5D-3L)
timeFrame: 6 weeks, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years post op
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References: