Constrained condylar versus posterior-stabilized bearings in revision knee replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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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Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.