Cemented vs Cementless Persona Keel RCT

Running, not enrolling · Not applicable

Conditions studied: Knee Pain Chronic, Rheumatoid Arthritis, Osteoarthritis, Traumatic Arthritis, Polyarthritis, Avascular Necrosis, Varus Deformity, Valgus Deformity, Flexion Deformity of Knee

In brief

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

Key facts

Study ID

NCT05630053

Run by

Zimmer Biomet

People needed

300

Starts

2023-07-25

Expected to finish

2032-12-01

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is of legal age and skeletally mature
• Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent document
• Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
• 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.

You may not qualify if…

• Patient is unwilling to sign the Informed Consent
• Patient is currently participating in any other surgical intervention or pain management study
• 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)
• Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
• 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
• Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
• Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty
• Study Device-Specific Exclusion Criteria:
• Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint
• Insufficient bone stock on femoral or tibial surfaces.
• Neuropathic arthropathy
• Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
• A stable, painless arthrodesis in a satisfactory functional position
• Severe instability secondary to the absence of collateral ligament integrity
• Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
• The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with MCL insufficiency

Where it is running

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

Full record on ClinicalTrials.gov

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