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Compares treatment options for Aseptic Loosening of Prosthetic Joint
Official title The Use of CCK vs PS in Revision TKAs
ClinicalTrials.gov ID: NCT06782295
What this study is testing
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patients who are at least 6-weeks out from primary TKA surgery, with complete pre-operative and post-operative knee radiographs obtained at standard...
- Patients undergoing rTKA for indications including aseptic component loosening, flexion or extension coronal or sagittal instability, component...
- The use of revision total knee arthroplasty systems which have PS and CCK bearing options including different degree options of coronal and...
You likely can't join if
- Patients undergoing rTKA with a hinged implant, or pre-operatively determined to require CCK bearing rTKA, \> 80 years of age, or those requiring...
- 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...
See the full eligibility 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...
- 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 assigned by chance per constrained...
- Zimmer Biomet Persona, NexGen, or Vanguard
- Smith and Nephew Legion
- DJO / Enovis Empowr
- Stryker Triathlon
- Link SymphoKnee
- Depuy Attune sion 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.