Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Launched by ZIMMER BIOMET · Mar 15, 2023

Keywords

ClinConnect Summary

The Persona OsseoTi Keel Compatibility Study is a clinical trial designed to evaluate a new type of knee implant called the Persona, which is used in total knee replacement surgery. The main goal of the study is to assess how safe and effective this implant is for patients suffering from various types of knee pain, including osteoarthritis and rheumatoid arthritis. If you are between the ages of 65 and 74 and are considering knee surgery, this trial may be an option for you. To participate, you need to be able to provide consent and attend follow-up appointments, and you should be eligible for knee replacement surgery based on your medical history.

As a participant in this study, you will receive the Persona implant and will be monitored for its performance and any potential benefits. However, some people may not be eligible to join, such as those currently involved in other medical studies or those with certain health conditions that could complicate surgery. This study is actively recruiting participants, and it could be a chance to receive a new treatment for your knee pain while contributing to important medical research.

Gender

ALL

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