Persona Outcomes Led Assessment Research in Total Knee Arthroplasty (POLAR - TKA)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Zimmer, GmbH
- 入组人数
- 777
- 试验地点
- 12
- 主要终点
- Kaplan-Meier Implant Survivorship
研究概览
简要总结
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona knee implants used in primary total knee arthroplasty. The assessment will include:
- Implant survivorship based on removal of a study device.
- Safety based on incidence and frequency of adverse events.
- Clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.
详细描述
This is a prospective, multicenter, non-controlled study of the commercially available Persona knee implants. The study will require each site to obtain Ethics approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
Study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 5 days to 6 weeks, 3 to 6 months, 1 year, 2, 3, 4, and 5 years after implantation. The hospital CHU Clermont-Ferrand, France with PI Prof. Boisgard will conduct additional 7 (voluntary) and 10 years (standard of care) follow-up visits.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient 18-75 years of age, inclusive.
- •Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of 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;
- •the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
- •Patient is willing and able to complete scheduled study procedures and follow-up evaluations.
- •Independent of study participation, patient is a candidate for commercially available Zimmer Persona knee implants implanted in accordance with product labeling.
排除标准
- •Patient is currently participating in any other surgical intervention studies or pain management studies.
- •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.
- •Skeletal immaturity.
- •Neuropathic arthropathy.
- •Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb.
- •Stable, painless arthrodesis in a satisfactory functional position.
- •Severe instability secondary to the absence of collateral ligament integrity.
- •Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
- •Patient has a known or suspected sensitivity or allergy to one or more of the implant materials.
- •Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).
- •Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.
结局指标
主要结局
Kaplan-Meier Implant Survivorship
时间窗: 5 years
Kaplan-Meier survivorship at 5 years with revision of any implant component, for any reason, as endpoint.
次要结局
- 'Knee injury and Osteoarthritis Outcome Score' (KOOS) subscale scores.(5 years)
- Oxford Knee Score (OKS)(5 years)
- EuroQol (EQ)-5D-3L score and EQ 'Visual Analog Scale' (VAS)(5 years)
- 'Forgotten Joint Score' (FJS-12)(5 years)