Clinical trial NCT04817969: Persona Ti-Nidium Post-Market Clinical Follow-up
Official title: Persona® Ti-Nidium® Personalized Total Knee System A Post-Market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data Using the Persona Ti-Nidium Total Knee System and Instrumentation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Pain Chronic
Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
Polyarthritis
Varus Deformity
Valgus Deformity
Flexion Deformity of the Knee
Avascular Necrosis
Patellofemoral Osteoarthritis
Keywords: Osteoarthritis
Rheumatoid Arthritis
Total Knee Arthroplasty
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2021-03-26
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (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).

Eligibility 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

Primary outcomes:
measure: Oxford Knee Score (OKS)
timeFrame: 10 years
Secondary outcomes:
measure: Knee Society Score (KSS) Expectations (pre and post op)
timeFrame: 10 years
measure: EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure
timeFrame: 10 years
Other outcomes:
Locations:
city: Parker
country: United States
facility: Denver Hip & Knee, Inc.
state: Colorado
city: Hyattsville
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Jackson
country: United States
facility: Mississippi Sports Medicine and Orthopaedic Center
state: Mississippi
city: Albuquerque
country: United States
facility: New Mexico Orthopaedic Associates
state: New Mexico
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
city: Rapid City
country: United States
facility: Monument Health Rapid City Hospital, Inc.
state: South Dakota
Study officials:
affiliation: Zimmer Biomet Assoc Director
name: Hillary Overholser
role: STUDY_DIRECTOR
References: