Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05787821
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Zimmer Biomet
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Hillary Overholser
Principal Investigator Affiliation Zimmer Biomet
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Pain Chronic, Osteoarthritis, Knee, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis, Varus Deformity, Valgus Deformity, Flexion Deformity of Knee, Avascular Necrosis
Additional Details

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).

Arms & Interventions

Arms

: Cohort 1

Cementless Femur Cementless Tibia

: Cohort 2

Cementless Femur Cementless Tibia

: Cohort 3

Cemented Femur Cemented Tibia

: Cohort 4

Cemented Femur Cemented Tibia

: Cohort 5

Cementless Femur Cemented Tibia

: Cohort 6

Cementless Femur Cemented Tibia

: Cohort 7

Cementless Femur Cemented Tibia

: Cohort 8

Cementless Femur Cemented Tibia

: Cohort 9

Cementless Femur Cementless Tibia

: Cohort 10

Cementless Femur Cementless Tibia

: Cohort 11

Intended to capture on-label configurations of newly cleared components not captured in cohorts 1-10.

: Cohort 12

Cementless Femur Cementless Tibia Cementless Patella

Interventions

Device: - Total Knee Arthroplasty

Total knee replacement.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Denver Hip & Knee, Inc., Parker 5434006, Colorado 5417618

Status

Recruiting

Address

Denver Hip & Knee, Inc.

Parker 5434006, Colorado 5417618, 80138

Site Contact

Amy Gridley

[email protected]

6473316652

Tampa 4174757, Florida 4155751

Status

Recruiting

Address

Foundation for Orthopaedic Research & Education

Tampa 4174757, Florida 4155751, 33607

Site Contact

Anne Meredith Baldy

[email protected]

6473316652

Northside Hospital, Inc., Atlanta 4180439, Georgia 4197000

Status

Recruiting

Address

Northside Hospital, Inc.

Atlanta 4180439, Georgia 4197000, 30342

Site Contact

Helene Foster

[email protected]

6473316652

U of L Health, Louisville 4299276, Kentucky 6254925

Status

Recruiting

Address

U of L Health

Louisville 4299276, Kentucky 6254925, 40202

Site Contact

Langan Smith

[email protected]

6473316652

University of Michigan, Ann Arbor 4984247, Michigan 5001836

Status

Recruiting

Address

University of Michigan

Ann Arbor 4984247, Michigan 5001836, 48109

Site Contact

Kaileigh Stuchlik

[email protected]

6473316652

Mayo Clinic, Rochester 5043473, Minnesota 5037779

Status

Recruiting

Address

Mayo Clinic

Rochester 5043473, Minnesota 5037779, 55902

Site Contact

Jana Robinson

[email protected]

6473316652

Jackson 4431410, Mississippi 4436296

Status

Recruiting

Address

Mississippi Sports Medicine and Orthopaedic Center

Jackson 4431410, Mississippi 4436296, 39202

Site Contact

Doug Parsell

[email protected]

6473316652

New Mexico Orthopaedic Associates, Albuquerque 5454711, New Mexico 5481136

Status

Recruiting

Address

New Mexico Orthopaedic Associates

Albuquerque 5454711, New Mexico 5481136, 87110

Site Contact

Kimberly Albrecht

[email protected]

6473316652

Syracuse Orthopaedic Specialists, DeWitt 5114617, New York 5128638

Status

Recruiting

Address

Syracuse Orthopaedic Specialists

DeWitt 5114617, New York 5128638, 13214

Site Contact

Travis Behm

[email protected]

6473316652

NYU, New York 5128581, New York 5128638

Status

Recruiting

Address

NYU

New York 5128581, New York 5128638, 11016

Site Contact

Daniel Waren

[email protected]

6473316652

St. Francis Hospital & Heart Center, Roslyn 5134415, New York 5128638

Status

Recruiting

Address

St. Francis Hospital & Heart Center

Roslyn 5134415, New York 5128638, 11576

Site Contact

Elizabeth Haag

[email protected]

6473316652

OrthoCarolina Research Institute, Inc., Charlotte 4460243, North Carolina 4482348

Status

Recruiting

Address

OrthoCarolina Research Institute, Inc.

Charlotte 4460243, North Carolina 4482348, 28207

Site Contact

Shannon O'Neal

[email protected]

6473316652

Duke University, Morrisville 4480285, North Carolina 4482348

Status

Recruiting

Address

Duke University

Morrisville 4480285, North Carolina 4482348, 27560

Site Contact

Jennifer Friend

[email protected]

6473316652

Cleveland Clinic, Cleveland 5150529, Ohio 5165418

Status

Recruiting

Address

Cleveland Clinic

Cleveland 5150529, Ohio 5165418, 44195

Site Contact

Karen Schemmel

[email protected]

6473316652

UT Health at Houston, Houston 4699066, Texas 4736286

Status

Recruiting

Address

UT Health at Houston

Houston 4699066, Texas 4736286, 77030

Site Contact

Layla Haidar

[email protected]

6473316652

UVA Health Orthopedic Center, Charlottesville 4752031, Virginia 6254928

Status

Recruiting

Address

UVA Health Orthopedic Center

Charlottesville 4752031, Virginia 6254928, 22903

Site Contact

Eric McVey, MEd, CCRP

[email protected]

6473316652