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Clinical Trials in the USA / NCT05630053
Active, not recruiting Not applicable

Cemented vs Cementless Persona Keel RCT

NCT05630053 · tracked via the Priya Life Science USA tracker
Sponsor
Zimmer Biomet
Phase
Not applicable
Started
2023-07-25
Last updated
2026-04-27

Condition(s) studied

Knee Pain ChronicRheumatoid ArthritisOsteoarthritisTraumatic ArthritisPolyarthritisAvascular NecrosisVarus DeformityValgus DeformityFlexion Deformity of Knee

Investigational drug(s) / intervention(s)

Cementless Persona Knee SystemCemented Persona Knee System

Cementless Persona Knee System: The Persona Keel Knee system is a total knee system used in the replacement of the knee joint.

Cemented Persona Knee System: The Persona Keel Knee system is a total knee system used in the replacement of the knee joint.

Study summary

The main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona Keel cementless and cemented knee.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Centura Health Westminster Colorado
Northwestern University Chicago Illinois
Johns Hopkins University Baltimore Maryland
Oregon Health & Science University Portland Oregon
Rothman Institute Bryn Mawr Pennsylvania
Lehigh Valley Hospital - Dickson City Dickson City Pennsylvania
Anderson Orthopaedic Research Institute Alexandria Virginia

More Zimmer Biomet trials in the USA

Other trials for the same condition

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 NCT05630053 on ClinicalTrials.gov ↗ ← All trials in the USA