Clinical Trials in Mexico / NCT05787821
Active, not recruiting
Observational
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
NCT05787821 · tracked via the Priya Life Science Mexico tracker
Condition(s) studied
Knee Pain ChronicOsteoarthritis, KneeRheumatoid ArthritisTraumatic ArthritisPolyarthritisVarus DeformityValgus DeformityFlexion Deformity of KneeAvascular Necrosis
Investigational drug(s) / intervention(s)
Total Knee Arthroplasty
Total Knee Arthroplasty: Total knee replacement.
Study summary
The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty
Eligibility
Inclusion Criteria:
1. Patient is of legal age and skeletally mature
2. Patient is willing and able to provide written Informed Consent by signing and dating the Institutional Review Board (IRB) / Ethics Committee (EC) approved Informed Consent document
3. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
4. Independent of study participation, patient qualifies for either cemented or cementless primary or revision total knee arthroplasty (including salvage of previously failed surgical attempts) based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling
Exclusion Criteria:
1. Patient is currently participating in any other surgical intervention or pain management study
2. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
3. Patient has a mental or neurological condition who is unwilling or incapable of following postoperative care instructions
4. Patient has a condition which would, in the judgment of the investigator, place the patient at undue risk or interfere with the conduct of the study
5. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
6. Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty
7. Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
8. Insufficient bone stock on femoral or tibial surfaces
9. Neuropathic arthropathy
10. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
11. A stable, painless arthrodesis in a satisfactory functional position
12. Severe instability secondary to the absence of collateral ligament integrity
13. Rheumatoid Arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
14. Patient has a \> 5˚ valgus deformity with a medial collateral ligament (MCL) insufficiency, and the surgeon intends to use the personalized alignment surgical technique
Primary outcome measure(s)
- Oxford Knee Score (OKS) — 5 years
A patient reported functional outcome score for knee arthroplasty. This score ranges from 0-48, with higher scores indicating a better outcome.
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| Denver Hip & Knee, Inc. | Parker | Colorado | |
| Foundation for Orthopaedic Research & Education | Tampa | Florida | |
| Northside Hospital, Inc. | Atlanta | Georgia | |
| U of L Health | Louisville | Kentucky | |
| University of Michigan | Ann Arbor | Michigan | |
| Mayo Clinic | Rochester | Minnesota | |
| Mississippi Sports Medicine and Orthopaedic Center | Jackson | Mississippi | |
| New Mexico Orthopaedic Associates | Albuquerque | New Mexico | |
| Syracuse Orthopaedic Specialists | DeWitt | New York | |
| NYU | New York | New York | |
| St. Francis Hospital & Heart Center | Roslyn | New York | |
| OrthoCarolina Research Institute, Inc. | Charlotte | North Carolina | |
| Duke University | Morrisville | North Carolina | |
| Cleveland Clinic | Cleveland | Ohio | |
| UT Health at Houston | Houston | Texas | |
| UVA Health Orthopedic Center | Charlottesville | Virginia |
More Zimmer Biomet trials in Mexico
Prospective G7 Dual Mobility Total Hip PMCF
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Persona Ti-Nidium Post-Market Clinical Follow-up
Active, not recruiting
Persona Partial Knee Clinical Outcomes Study
Active, not recruiting
Other trials for the same condition
"Effect of Vitamin E (α-Tocopherol) on Clinical Activity and Inflammation in Rheumatoid Arthritis"
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A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05787821 on ClinicalTrials.gov ↗ ← All trials in Mexico