Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Recruiting

• Conditions: Rheumatoid Arthritis; Traumatic Arthritis; Polyarthritis; Valgus Deformity; Avascular Necrosis; Knee Pain Chronic; Varus Deformity; Flexion Deformity of Knee; Osteoarthritis, Knee
• Interventions: Device: Total Knee Arthroplasty

• Registration Number: NCT05787821
• Lead Sponsor: Zimmer Biomet

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).

Study Timeline

• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-28
• Study Start: 2023-06-28
• Status Verified: 2024-09
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2026-06
• Study Completion: 2035-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 760

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Total Knee Arthroplasty	Cementless Femur Cementless Tibia
Cohort 2	Total Knee Arthroplasty	Cementless Femur Cementless Tibia
Cohort 3	Total Knee Arthroplasty	Cemented Femur Cemented Tibia
Cohort 4	Total Knee Arthroplasty	Cemented Femur Cemented Tibia
Cohort 5	Total Knee Arthroplasty	Cementless Femur Cemented Tibia
Cohort 6	Total Knee Arthroplasty	Cementless Femur Cemented Tibia
Cohort 7	Total Knee Arthroplasty	Cementless Femur Cemented Tibia
Cohort 8	Total Knee Arthroplasty	Cementless Femur Cemented Tibia
Cohort 9	Total Knee Arthroplasty	Cementless Femur Cementless Tibia
Cohort 10	Total Knee Arthroplasty	Cementless Femur Cementless Tibia
Cohort 11	Total Knee Arthroplasty	Intended to capture on-label configurations of newly cleared components not captured in cohorts 1-10.

Primary Outcome Measures

Name	Time	Method
Oxford Knee Score (OKS)	5 years	A patient reported functional outcome score for knee arthroplasty. This score ranges from 0-48, with higher scores indicating a better outcome.

Secondary Outcome Measures

Name	Time	Method
EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure	5 years	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.
Pain and Satisfaction Numeric Rating Scale (NRS)	5 years	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".

Trial Locations

Locations (16)

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