Cemented vs Cementless Persona Keel RCT

Launched by ZIMMER BIOMET · Nov 17, 2022

Keywords

ClinConnect Summary

The "Cemented vs Cementless Persona Keel RCT" clinical trial is studying two types of knee replacement surgery: one using cement and one that does not. The main goal is to see which method is safer, works better, and offers more benefits for patients with chronic knee pain due to conditions like arthritis and other knee issues. If you are between the ages of 65 and 74, and if your doctor thinks you need a knee replacement, you might be eligible to participate in this study. You will need to be able to provide written consent and attend follow-up appointments after the surgery.

If you join this study, you will undergo either a cemented or cementless knee replacement and will be monitored over time to check how well the surgery works for you. It’s important to know that there are some criteria that might exclude you from participating, such as if you have certain medical conditions or if you are currently involved in other studies. Overall, this trial aims to help improve treatment options for patients needing knee replacements.

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 IRB/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 total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona Keel Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling.
• Exclusion Criteria:
• • 1. Patient is unwilling to sign the Informed Consent
• • 2. Patient is currently participating in any other surgical intervention or pain management study
• • 3. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study would be inappropriate (e.g., prisoner; pediatric patients)
• • 4. Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
• • 5. Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study
• • 6. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
• • 7. Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty
• Study Device-Specific Exclusion Criteria:
• • 8. Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint
• • 9. Insufficient bone stock on femoral or tibial surfaces.
• • 10. Neuropathic arthropathy
• • 11. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
• • 12. A stable, painless arthrodesis in a satisfactory functional position
• • 13. Severe instability secondary to the absence of collateral ligament integrity
• • 14. Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
• • 15. The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with MCL insufficiency