Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Sponsor

Zimmer Biomet (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05787821

Collaborator

(none)

660

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Knee Pain Chronic Osteoarthritis, Knee Rheumatoid Arthritis Traumatic Arthritis Polyarthritis Varus Deformity Valgus Deformity Flexion Deformity of Knee Avascular Necrosis

Detailed 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, and 5 years post-operatively.

Specific assessments include:

Confirming the safety, performance and clinical benefits of the Persona total knee system and instrumentation in primary and revision TKA.
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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

660 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2031

Anticipated Study Completion Date :

Jun 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 Cementless Femur Cementless Tibia
Cohort 2 Cementless Femur Cementless Tibia
Cohort 3 Cemented Femur Cemented Tibia
Cohort 4 Cemented Femur Cemented Tibia
Cohort 5 Cementless Femur Cemented Tibia
Cohort 6 Cementless Femur Cemented Tibia
Cohort 7 Cementless Femur Cemented Tibia
Cohort 8 Cementless Femur Cemented Tibia
Cohort 9 Cementless Femur Cementless Tibia
Cohort 10 Cementless Femur Cementless Tibia
Cohort 11 Intended to capture on-label configurations of newly cleared components not captured in cohorts 1-10.

Outcome Measures

Primary Outcome Measures

Oxford Knee Score (OKS) [5 years]
A patient reported functional outcome score for knee arthroplasty. This score ranges from 0-48, with higher scores indicating a better outcome.

Secondary Outcome Measures

EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure [5 years]
A questionnaire completed by the patient and assesses his/her general health status. This score ranges from -0.573 to 1, with higher recorded scores indicating better overall health.
Pain and Satisfaction Numeric Rating Scale (NRS) [5 years]
Patients will rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"). Along with their pain rating, subjects will be asked to rate their current satisfaction with their surgery from "Very Dissatisfied" to "Very Satisfied".

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient is of legal age and skeletally mature
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
Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol
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:

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 neurological condition who is unwilling or incapable of following postoperative care instructions
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
Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty
Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
Insufficient bone stock on femoral or tibial surfaces
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
Patient has a > 5˚ valgus deformity with a medial collateral ligament (MCL) insufficiency, and the surgeon intends to use the personalized alignment surgical technique