Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Running, not enrolling

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

In brief

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

Key facts

Study ID

NCT05787821

Run by

Zimmer Biomet

People needed

760

Starts

2023-06-28

Expected to finish

2035-06-01

Last updated by the study team

2026-07-10

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 Institutional Review Board (IRB) / Ethics Committee (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 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

You may not qualify if…

• 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 is inappropriate (e.g. prisoner, mentally incompetent)
• Patient has a mental or neurological condition who is unwilling or incapable of following postoperative care instructions
• 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
• 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
• Previous history of infection in the affected joint and/or other local/systemic 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
• Patient has a > 5˚ valgus deformity with a medial collateral ligament (MCL) insufficiency, and the surgeon intends to use the personalized alignment surgical technique

Where it is running

• Denver Hip & Knee, Inc. — Parker, Colorado, United States
• Foundation for Orthopaedic Research & Education — Tampa, Florida, United States
• Northside Hospital, Inc. — Atlanta, Georgia, United States
• U of L Health — Louisville, Kentucky, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Mississippi Sports Medicine and Orthopaedic Center — Jackson, Mississippi, United States
• New Mexico Orthopaedic Associates — Albuquerque, New Mexico, United States
• Syracuse Orthopaedic Specialists — DeWitt, New York, United States
• NYU — New York, New York, United States
• St. Francis Hospital & Heart Center — Roslyn, New York, United States
• OrthoCarolina Research Institute, Inc. — Charlotte, North Carolina, United States
• Duke University — Morrisville, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• UT Health at Houston — Houston, Texas, United States
• UVA Health Orthopedic Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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