Constrained condylar versus posterior-stabilized bearings in revision knee replacement
A Prospective Randomized Controlled Trial Comparing Constrained Condylar vs Posterior Stabilized Articulations in Revision Total Knee Arthroplasty
This study will test whether constrained condylar (CCK) or posterior-stabilized (PS) knee bearings give better satisfaction, fewer problems, and longer implant survival for adults getting revision total knee replacement.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06782295 on ClinicalTrials.gov |
What this trial studies
Adults undergoing revision total knee arthroplasty will receive either a CCK or PS bearing as part of their revision procedure and outcomes will be compared in the early to mid-term. The study will collect patient-reported outcome measures, radiographs, and record reoperations and complications such as instability. Both isolated femoral revisions with compatible retained tibial components and combined femoral and tibial revisions are eligible. The primary focus is on differences in clinical outcomes and survivorship free of further revision surgery.
Who should consider this trial
Good fit: Adults aged 18–80 undergoing femoral and tibial component revision, or isolated femoral revision with a tibial component compatible with CCK or PS bearings, for causes such as aseptic loosening, instability, malalignment, arthrofibrosis, patellar problems, wear, or reimplantation after infection are ideal candidates.
Not a fit: Patients outside the 18–80 age range, those whose existing tibial component is not compatible with the tested bearing options, or those who require a different level of implant constraint than provided may not benefit from this comparison.
Why it matters
Potential benefit: If successful, the results could help surgeons choose the bearing that improves patient satisfaction and reduces the need for repeat surgery after revision knee replacement.
How similar studies have performed: Prior observational studies have reported comparable outcomes for varying constraint levels in revision knees, but direct comparative data between CCK and PS bearings are limited and higher-quality comparative evidence is sparse.
Eligibility criteria
Show full inclusion / exclusion 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. \-
Where this trial is running
Chicago, Illinois
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Omary Behery, MD
- Email: omar.behery@rushortho.com
- Phone: 630-339-2230
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.