RECRUITINGOBSERVATIONAL
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
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
About This Trial
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
Who May Be Eligible (Plain English)
Who May Qualify:
1. Patient is of legal age and skeletally mature
2. Patient is willing and able to provide written willing to sign a consent form by signing and dating the Institutional Review Board (IRB) / Ethics Committee (EC) approved willing to sign a consent form 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
Who Should NOT Join This Trial:
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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
Total Knee Arthroplasty
Total knee replacement.
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