NexGen® TM Tibia Clinical Outcomes Study: Prospective Multicenter Study of the NexGen® TM Monoblock and Modular Tibias
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 14
- 主要终点
- Radiograph Assessment of Progressive Tibial Radiolucencies
研究概览
简要总结
The objective of this study is to evaluate clinical performance for the commercially available NexGen TM Monoblock Tibia and NexGen TM Modular Tibia used in primary cementless tibia total knee arthroplasty.
详细描述
This is a prospective, multicenter, non-randomized clinical study designed to facilitate the collection and evaluation of radiographic parameters, pain and function, survival of the device, and adverse event data. This clinical study will include the NexGen TM Monoblock Tibia and NexGen TM Modular Tibia as 2 single-arms being analyzed separately.
The study will require each site to obtain 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 cementless tibia total knee arthroplasty. An immediate postoperative radiograph will be required. Postoperative clinical follow-up and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, and 2 years.
The primary endpoint of this study is to evaluate the clinical performance of the implant at 2 years postoperatively using radiographic parameters. Radiographs will be assessed for the absence of progressive tibial radiolucencies, as defined in the radiographic protocol.
The secondary endpoints of this study will evaluate the clinical performance of the implant at 2 years postoperatively, based upon:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 at least 18 years of age.
- •Patient qualifies for a primary cementless tibia 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 has participated in the study-related Informed Consent process.
- •Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved Informed Consent Form.
- •Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form.
- •Independent of study participation, patient is a candidate for commercially available cementless NexGen TM tibial knee component, implanted in accordance with product labeling.
排除标准
- •Previous history of infection in the affected joint.
- •Active local or 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.
- •A 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 previously received partial or total knee arthroplasty for the ipsilateral knee.
- •Patient is currently participating in any other surgical intervention studies or pain management studies.
- •Patient is known to be pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).
- •Patient has a known or suspected sensitivity or allergy to one or more of the implant materials.
结局指标
主要结局
Radiograph Assessment of Progressive Tibial Radiolucencies
时间窗: 2 years
Progressive tibial radiolucency will be derived in accordance with the following definitions: Absent: No evidence of an increase in either radiolucency extent (number of zones involved) or measured width within a zone. Present: Presence of either: An increase in the number of zones with a measured tibial radiolucency, OR an increase in the measured tibial radiolucency width within a zone of \>0.5mm. Unable to assess: One or more of the component factors necessary to derive progressive tibial radiolucency is unavailable.
次要结局
- Oxford Knee Score(2 years)
- Revision Rate(2 years)