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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

Locations
United States
Illinois
Rush University Medical Center
RECRUITING
Chicago
Contact Information
Primary
Omary Behery, MD
omar.behery@rushortho.com
630-339-2230
Backup
Anne DeBenedetti, MSc
anne.debenedetti@rushortho.com
312-432-2468
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2038-07-01
Participants
Target number of participants: 170
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Rush University Medical Center

This content was sourced from clinicaltrials.gov