Status:
ACTIVE_NOT_RECRUITING
Persona Ti-Nidium Post-Market Clinical Follow-up
Lead Sponsor:
Zimmer Biomet
Conditions:
Knee Pain Chronic
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.
Detailed Description
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 (I...
Eligibility Criteria
Inclusion
- Patient is of legal age and skeletally mature
- Patient is willing and able to provide written Informed Consent by signing and dating the IRB-approved Informed Consent document
- Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
- 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
- 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
- The Persona Ti-Nidium Total Knee is intended for patients with severe pain and disability due to the following:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
Exclusion
- Patient is unwilling to sign the Informed Consent
- Patient is currently participating in any other surgical intervention or pain management study
- Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)
- Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
- 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
- Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
- Study Device Exclusion Criteria
- Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint
- Insufficient bone stock on femoral or tibial surfaces
- Skeletal immaturity
- Neuropathic arthropathy
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
- A stable, painless arthrodesis in a satisfactory functional position
- Severe instability secondary to the absence of collateral ligament integrity
- Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
- The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with medial collateral ligament (MCL) insufficiency
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2034
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04817969
Start Date
June 1 2021
End Date
May 1 2034
Last Update
October 24 2025
Active Locations (7)
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1
Denver Hip & Knee, Inc.
Parker, Colorado, United States, 80134
2
MedStar Health Research Institute
Hyattsville, Maryland, United States, 20782
3
Mississippi Sports Medicine and Orthopaedic Center
Jackson, Mississippi, United States, 39202
4
New Mexico Orthopaedic Associates
Albuquerque, New Mexico, United States, 87110