Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:34 PM
Ignite Modification Date:
2025-12-24 @ 1:34 PM
NCT ID:
NCT06782295
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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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06782295
Study Brief:
Protocol Section:
NCT06782295