RECRUITING

Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2023-06-28

Study Completion:2035-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05787821

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Erik Kowalski, PhD

CONTACT

6473316652

erik.kowalski@zimmerbiomet.com

Principal Investigator

Hillary Overholser

STUDY_DIRECTOR

Zimmer Biomet

Study Locations (Sites)

Denver Hip & Knee, Inc.

Parker, Colorado, 80138

United States

Foundation for Orthopaedic Research & Education

Tampa, Florida, 33607

United States

Northside Hospital, Inc.

Atlanta, Georgia, 30342

United States

U of L Health

Louisville, Kentucky, 40202

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Mayo Clinic

Rochester, Minnesota, 55902

United States

Mississippi Sports Medicine and Orthopaedic Center

Jackson, Mississippi, 39202

United States

New Mexico Orthopaedic Associates

Albuquerque, New Mexico, 87110

United States

Syracuse Orthopaedic Specialists

DeWitt, New York, 13214

United States

NYU

New York, New York, 11016

United States

St. Francis Hospital & Heart Center

Roslyn, New York, 11576

United States

OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina, 28207

United States

Duke University

Morrisville, North Carolina, 27560

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Southern Joint Replacement Institute

Nashville, Tennessee, 37203

United States

UT Health at Houston

Houston, Texas, 77030

United States

UVA Health Orthopedic Center

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: Zimmer Biomet

Hillary Overholser, STUDY_DIRECTOR, Zimmer Biomet

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-28

Study Completion Date2035-06

Study Record Updates

Study Start Date2023-06-28

Study Completion Date2035-06

Terms related to this study

Keywords Provided by Researchers

Osteoarthritis
Total Knee Arthroplasty

Additional Relevant MeSH Terms

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