Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
170 participants
INTERVENTIONAL
2025-07-01
2038-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Constrained Condylar bearing
Patients in this intervention will receive a CCK bearing component
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.
posterior stabilized bearing
Patients in this intervention will receive a PS bearing component
Interventions
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Constrained Condylar bearing
Patients in this intervention will receive a CCK bearing component
posterior stabilized bearing
Patients in this intervention will receive a PS bearing component
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
\-
18 Years
ALL
No
Sponsors
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Rush University Medical Center
OTHER
Responsible Party
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Omar Behery
Principle Investigator
Locations
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Rush University Medical Center
Chicago, Illinois, United States
Countries
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Central Contacts
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Other Identifiers
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25010208
Identifier Type: -
Identifier Source: org_study_id
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