NCT01704326已完成不适用
A Prospective, Multicenter Consecutive Series Study of Patients Treated With the Journey Deuce Bicompartmental Knee System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 4
- 主要终点
- Change in Knee Society Score
研究概览
简要总结
This is a prospective, multicenter, consecutive clinical study of the Journey Deuce Knee System and is intended to evaluate the safety and effectiveness of the new device.
详细描述
The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System. Patients will be examined clinically at time intervals throughout the study duration. Exams will include completion of clinical assessment, x-rays, and completion of patient questionnaires.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient presents with non-inflammatory degenerative joint disease of the medial and patellofemoral compartments requiring a unilateral knee replacement.
- •Patient is 30 to 75 years of age, inclusive.
- •Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form.
- •Patient plans to be available for follow-up through five years postoperative.
排除标准
- •Patient is known to have insufficient femoral or tibial bone stock resulting from conditions such as cancer, distal femoral/proximal tibial osteotomy, significant osteoporosis or metabolic bone disorders.
- •Patient is immunosuppressed, has an autoimmune disorder, or an immunosuppressive disorder (i.e. chronic condition characterized by markedly inhibited ability to respond to antigenic stimuli.) Examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses) or patients with acquired immunodeficiency syndrome (AIDS).
- •Patient has inflammatory arthritis (e.g. rheumatoid arthritis)
- •Patient has BMI greater than or equal to
- •Patient has had major knee surgery in the past i.e. HTO, unicondylar knee replacement, failed fracture fixation.
- •Patient has an active infection, local or systemic.
- •Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and followup (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as Parkinson, Multiple sclerosis, etc.).
- •Patient has ACL deficiency in the study knee.
- •Patient has hip arthritis and/or replacement.
- •Patient has lateral compartment disease.
- •Patient is pregnant or plans to become pregnant during the course of the study.
- •Patient has a known sensitivity to materials in the device.
结局指标
主要结局
Change in Knee Society Score
时间窗: Preoperative-2 years
Assess knee pain, function and range of motion using the Knee Society Clinical Rating System
次要结局
- Oxford Knee Outcome Questionnaire(Preoperative, 6 weeks, 3 months, 6 months, 1 year and 2 years)
- Radiographic Evaluation(6 weeks, 1 year and 2 years)
- Patient Satisfaction(6 weeks, 3 months, 6 months, 1 year and 2 years)
- Adverse Events(When Necessary)
研究者
研究点 (4)
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