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NCT05787821 | RECRUITING | Knee Pain Chronic

Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
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

Condition or disease

Knee Pain Chronic

Osteoarthritis, Knee

Rheumatoid Arthritis

Traumatic Arthritis

Polyarthritis

Varus Deformity

Valgus Deformity

Flexion Deformity of Knee

Avascular Necrosis

Intervention/treatment

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, 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).

Study Type : OBSERVATIONAL
Estimated Enrollment : 660 participants
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
Actual Study Start Date : 2023-06-28
Estimated Primary Completion Date : 2031-06
Estimated Study Completion Date : 2031-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Location Details

NCT05787821

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

Denver Hip & Knee, Inc.

Parker, Colorado, United States, 80138

RECRUITING

United States, Florida

Foundation for Orthopaedic Research & Education

Tampa, Florida, United States, 33607

RECRUITING

United States, Georgia

Northside Hospital, Inc.

Atlanta, Georgia, United States, 30342

RECRUITING

United States, Kentucky

U of L Health

Louisville, Kentucky, United States, 40202

RECRUITING

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

NOT YET RECRUITING

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55902

RECRUITING

United States, Mississippi

Mississippi Sports Medicine and Orthopaedic Center

Jackson, Mississippi, United States, 39202

RECRUITING

United States, New Mexico

New Mexico Orthopaedic Associates

Albuquerque, New Mexico, United States, 87110

RECRUITING

United States, New York

Syracuse Orthopaedic Specialists

DeWitt, New York, United States, 13214

RECRUITING

United States, New York

NYU

New York, New York, United States, 11016

RECRUITING

United States, New York

St. Francis Hospital & Heart Center

Roslyn, New York, United States, 11576

RECRUITING

United States, North Carolina

OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina, United States, 28207

RECRUITING

United States, North Carolina

Duke University

Morrisville, North Carolina, United States, 27560

RECRUITING

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

RECRUITING

United States, Tennessee

Southern Joint Replacement Institute

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

UT Health at Houston

Houston, Texas, United States, 77030

RECRUITING

United States, Virginia

UVA Health Orthopedic Center

Charlottesville, Virginia, United States, 22903