NCT02362867已完成不适用
Balanced Knee System Clinical Protocol for IRB Approval
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 主要终点
- Evaluate effectiveness of the BKS by assessing complications during surgery and the post-operative follow-up period
研究概览
简要总结
The protocol will define the clinical study for Ortho Development's Balanced Knee® System (BKS) for subsequent review and approval by an Institutional Review Board (IRB).This clinical study will compare the clinical outcomes of BKS to currently marketed devices.
详细描述
The rationale is based on the potential effectiveness of the BKS to:
- Return patient to normal activities or increase mobility by restoring knee function.
- Provide stability to enhance rehabilitation without external support.
- Eliminate or reduce knee pain.
- Assess the clinical efficacy after total knee replacement.
- Determine implant survivorship and viability.
- Evaluate patient function and satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Loss of joint configuration and joint function.
- •Osteoarthritis of the knee joint.
- •Rheumatoid arthritis of the knee joint.
- •Post-traumatic arthritis of the knee joint.
- •Moderate valgus, varus, or flexion deformities.
排除标准
- •Any patient not experiencing a compromised quality of life by loss of joint function and/or joint configuration, or pain from arthritis disease.
- •Any patient whose knee cannot be returned to normal function and normal stability through reconstructive procedures, including ligamentous balancing.
- •Active infection in or near the knee joint, fever and/or local inflammation signs, and elevation of sedimentation rate unexplained by other diseases should not be treated unless preoperative infection is ruled out.
- •Distant foci of infection, such as genitourinary, pulmonary, skin (chronic lesions or ulcerations), and other sites, which may result in hematogenous spread to the implant site.
- •Rapid joint destruction or bone absorption apparent on roentgenograms.
- •Neuromuscular disorders in which the potentially adverse effects on prosthesis function are not outweighed by the benefits gained by the patient from usage of the prosthesis.
- •Mental disorders which would compromise essential patient post-operative care.
- •A painless, stable arthrodesis in a functional position.
- •Allergic reactions to implant materials, and/or tissue reactions to the products of corrosion or wear.
- •Skeletal immaturity.
- •Any patient who is unwilling or unable to comply with post-operative instructions or clinical study requirements.
结局指标
主要结局
Evaluate effectiveness of the BKS by assessing complications during surgery and the post-operative follow-up period
时间窗: 1-10 years
次要结局
- Identify any surveillance issues regarding the device design and surgical approach used refinement of the surgical technique(1-10 years)
- Evaluate device performance through the use of the Knee Society Score, Short Form-36 Health Survey, and radiographic evaluation.(1-10 years)
- Assess the effectiveness of the BKS by analyzing radiographic evidence and clinical data.(1-10 years)
研究者
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