Clinical trial NCT05787821: Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
Official title: Persona® OsseoTi® Keel Compatibility Study-A Multicenter Cohort Study A Prospective, Post-market Clinical Follow-up Study to Demonstrate Safety, Performance and Clinical Benefits of the Persona Knee System Portfolio and Its Instrumentation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Pain Chronic
Osteoarthritis, Knee
Rheumatoid Arthritis
Traumatic Arthritis
Polyarthritis
Varus Deformity
Valgus Deformity
Flexion Deformity of Knee
Avascular Necrosis
Keywords: Osteoarthritis
Total Knee Arthroplasty
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2023-03-28
Enrollment: 760
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be a subset of the US population electing to proceed with total knee arthroplasty irrespective of participation in the study and: 1) who will be receiving one or more of the components of interest as part of standard clinical care, 2) agree to participate by completing a study-specific informed consent form, and 3) who satisfy the inclusion/exclusion criteria.

Brief summary: 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

Detailed description: The study design is a prospective, multicenter data collection model of the 510(k) cleared Persona Total Knee System. The study will require each site to obtain institutional review board (IRB) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.

All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty (TKA). Investigators will collect clinical data for a required 5 years. Follow-up clinical visits include 3 months, 1, 2, 5, 7 and 10 years post-operatively.

Specific assessments include:

1. Confirming the safety, performance and clinical benefits of the Persona total knee system and instrumentation in primary and revision TKA.
2. Verifying that, under normal use, the performance and clinical benefits of this device and its instrumentation conform to those intended by the manufacturer by recording patient-reported clinical outcomes measures (PROMs) and radiographic outcomes (if available).

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

Primary outcomes:
measure: Oxford Knee Score (OKS)
timeFrame: 5 years
Secondary outcomes:
measure: EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure
timeFrame: 5 years
measure: Pain and Satisfaction Numeric Rating Scale (NRS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Parker
country: United States
facility: Denver Hip & Knee, Inc.
state: Colorado
city: Tampa
country: United States
facility: Foundation for Orthopaedic Research & Education
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital, Inc.
state: Georgia
city: Louisville
country: United States
facility: U of L Health
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: Mississippi Sports Medicine and Orthopaedic Center
state: Mississippi
city: Albuquerque
country: United States
facility: New Mexico Orthopaedic Associates
state: New Mexico
city: DeWitt
country: United States
facility: Syracuse Orthopaedic Specialists
state: New York
city: New York
country: United States
facility: NYU
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital & Heart Center
state: New York
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute, Inc.
state: North Carolina
city: Morrisville
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Houston
country: United States
facility: UT Health at Houston
state: Texas
city: Charlottesville
country: United States
facility: UVA Health Orthopedic Center
state: Virginia
Study officials:
affiliation: Zimmer Biomet
name: Hillary Overholser
role: STUDY_DIRECTOR
References: