NCT05787821 Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
| NCT ID | NCT05787821 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zimmer Biomet |
| Condition | Knee Pain Chronic |
| Study Type | OBSERVATIONAL |
| Enrollment | 760 participants |
| Start Date | 2023-06-28 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 760 participants in total. It began in 2023-06-28 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Hillary Overholser
STUDY DIRECTOR
Zimmer Biomet
Frequently Asked Questions
Who can join the NCT05787821 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Knee Pain Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05787821 currently recruiting?
Yes, NCT05787821 is actively recruiting participants. Contact the research team at erik.kowalski@zimmerbiomet.com for enrollment information.
Where is the NCT05787821 trial being conducted?
This trial is being conducted at Parker, United States, Tampa, United States, Atlanta, United States, Louisville, United States and 11 additional locations.
Who is sponsoring the NCT05787821 clinical trial?
NCT05787821 is sponsored by Zimmer Biomet. The principal investigator is Hillary Overholser at Zimmer Biomet. The trial plans to enroll 760 participants.