Persona Ti-Nidium Post-Market Clinical Follow-up

Study Purpose

The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in 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.	Interventional
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 IRB-approved Informed Consent document. 3. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol. 4. Patient qualifies for total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the Persona Ti-Nidium Knee System and Vivacit-E polyethylene articulating surface. 5. Independent of study participation, patient is a candidate for the commercially available Persona Ti-Nidium Knee and Vivacit-E polyethylene articulating surface, implanted in accordance with product labeling. Study Device

Inclusion Criteria:

The Persona Ti-Nidium Total Knee is intended for patients with severe pain and disability due to the following: 1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. 2. Collagen disorders, and/or avascular necrosis of the femoral condyle. 3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. 4. Moderate valgus, varus, or flexion deformities.

Exclusion Criteria:

1. Patient is unwilling to sign the Informed Consent. 2. Patient is currently participating in any other surgical intervention or pain management study. 3. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent) 4. Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions. 5. Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study. 6. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation. Study Device Exclusion Criteria. 1. Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint. 2. Insufficient bone stock on femoral or tibial surfaces. 3. Skeletal immaturity. 4. Neuropathic arthropathy. 5. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb. 6. A stable, painless arthrodesis in a satisfactory functional position. 7. Severe instability secondary to the absence of collateral ligament integrity. 8. Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin. 9. The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with medial collateral ligament (MCL) insufficiency

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.	NCT04817969
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.	N/A
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 Assoc Director
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, Rheumatoid Arthritis, Traumatic Arthritis, Polyarthritis, Varus Deformity, Valgus Deformity, Flexion Deformity of the Knee, Avascular Necrosis, Patellofemoral Osteoarthritis

Additional Details

The study design is a prospective, multicenter data collection model of the 510(k) cleared Persona Ti-Nidium 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. Investigators will collect clinical data for a required 10 years. Follow-up clinical visits include Early Post-op, 6 months, 1 year, 2, 3, 5, 7 and 10 years post-operatively. The objective of this study is to evaluate clinical performance, benefits and safety of the Persona Ti-Nidium implant in total knee arthroplasty. Specific assessments include: 1. Confirming the long-term safety, performance and clinical benefits of the Persona Ti-Nidium 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

Other: Persona Ti-Nidium

Primary total knee arthroplasty subjects that receive the Zimmer Biomet Persona Ti-Nidium Total Knee System

Interventions

Device: - Zimmer Biomet Persona Ti-Nidium Total Knee System

Primary Knee Total Arthroplasty

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, Colorado

Status

Recruiting

Address

Denver Hip & Knee, Inc.

Parker, Colorado, 80134

Site Contact

Amy Gridley

[email protected]

303-925-4750

MedStar Health Research Institute, Hyattsville, Maryland

Status