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

Zimmer Biomet31 个研究点分布在 1 个国家目标入组 760 人开始时间: 2023年6月28日最近更新: 2026年7月10日

适应症

干预措施

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Zimmer Biomet
入组人数: 760
试验地点: 31
主要终点: Oxford Knee Score (OKS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

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:

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).

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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