Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Zimmer Biomet

Status: Enrolling

Conditions: Valgus Deformity; Traumatic Arthritis; Knee Pain Chronic; Polyarthritis; Avascular Necrosis; Flexion Deformity of Knee; Varus Deformity; Rheumatoid Arthritis; Osteoarthritis, Knee

Treatments: Device: Total Knee Arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT05787821

CMU2022-39K

Details and patient eligibility

About

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

Full 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, 5, 7 and 10 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).

Enrollment: 760 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

760 participants in 12 patient groups

Cohort 1

Description:

Cementless Femur Cementless Tibia

Treatment:

Device: Total Knee Arthroplasty

Cohort 2

Description:

Cementless Femur Cementless Tibia

Treatment:

Device: Total Knee Arthroplasty

Cohort 3

Description:

Cemented Femur Cemented Tibia

Treatment:

Device: Total Knee Arthroplasty

Cohort 4

Description:

Cemented Femur Cemented Tibia

Treatment:

Device: Total Knee Arthroplasty

Cohort 5

Description:

Cementless Femur Cemented Tibia

Treatment:

Device: Total Knee Arthroplasty

Cohort 6

Description:

Cementless Femur Cemented Tibia

Treatment:

Device: Total Knee Arthroplasty

Cohort 7

Description:

Cementless Femur Cemented Tibia

Treatment:

Device: Total Knee Arthroplasty

Cohort 8

Description:

Cementless Femur Cemented Tibia

Treatment:

Device: Total Knee Arthroplasty

Cohort 9

Description:

Cementless Femur Cementless Tibia

Treatment:

Device: Total Knee Arthroplasty

Cohort 10

Description:

Cementless Femur Cementless Tibia

Treatment:

Device: Total Knee Arthroplasty

Cohort 11

Description:

Intended to capture on-label configurations of newly cleared components not captured in cohorts 1-10.

Treatment:

Device: Total Knee Arthroplasty

Cohort 12

Description:

Cementless Femur Cementless Tibia Cementless Patella

Treatment:

Device: Total Knee Arthroplasty