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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05787821
Other study ID # CMU2022-39K
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 28, 2023
Est. completion date June 2031

Study information

Verified date June 2024
Source Zimmer Biomet
Contact Tim Swanson
Phone 5745497606
Email tim.swanson@zimmerbiomet.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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, and 5 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 660
Est. completion date June 2031
Est. primary completion date June 2031
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oxford Knee Score (OKS) A patient reported functional outcome score for knee arthroplasty. This score ranges from 0-48, with higher scores indicating a better outcome. 5 years
Secondary EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure A questionnaire completed by the patient and assesses his/her general health status. This score ranges from -0.573 to 1, with higher recorded scores indicating better overall health. 5 years
Secondary Pain and Satisfaction Numeric Rating Scale (NRS) Patients will rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"). Along with their pain rating, subjects will be asked to rate their current satisfaction with their surgery from "Very Dissatisfied" to "Very Satisfied". 5 years
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