Prospective Multi-centre Outcomes Study of Persona Knee System in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,017
- 试验地点
- 18
- 主要终点
- Adverse Events (Safety)
研究概览
简要总结
This is a prospective, multi-centre, non comparative, post market clinical follow-up study involving orthopaedic surgeons skilled in TKA and experienced implanting the devices included in this study.
详细描述
The objectives of the study are to document the implant survivorship and clinical outcomes data for the Persona fixed bearing implants used in primary total knee arthroplasty (TKA). The study will include a maximum of 20 centres and up to 1000 implanted knees. Each centre may enrol up to a maximum of 100 implanted knees to permit assessment of the consistency of outcomes across a variety of investigators and clinical settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years old, inclusive
- •Qualifies for a primary TKA 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 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.
- •Participated in a study-related informed consent process.
- •Willing and able to provide written informed consent by signing and dating the IRB/EC approved informed consent form.
- •Willing and able to complete scheduled study procedures and follow-up evaluations.
- •Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee system implanted in accordance with product labelling.
排除标准
- •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
- •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.
- •Known or suspected sensitivity or allergy to one or more of the implant materials.
- •Pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent, etc.)
- •Previously received partial or total knee arthroplasty for the ipsilateral knee.
结局指标
主要结局
Adverse Events (Safety)
时间窗: Up to 5 years post surgery
Safety based on incidence and frequency of adverse events
Clinical Performance
时间窗: Up to 5 years post surgery
Clinical Performance measured by physician assessment of radiographs form. Data collected include the position and assessment of the radiographs of the operated knee
Implant Survivorship
时间窗: Up to 5 years post surgery
Implant survivorship based on removal of the study device and will be summarized using Kaplan-Meier analysis
次要结局
未报告次要终点