A Prospective, Single-Center, Randomized Study Comparing the Functional Performance of the Journey Deuce Bicompartmental With the Genesis II Total Knee System
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- 2-Year Knee Society Score
研究概览
简要总结
The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System at 4-6 weeks, 4 months, 1 year, and 2 years when compared to total knee replacement using the Genesis II Total Knee System. The hypothesis is that the Journey Deuce Bicompartmental Knee System is as safe and effective as the Genesis II Total Knee System at the 2-year. The null hypothesis is that there is no difference between the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 65 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 2 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 >
- •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 follow-up (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 is on workman's compensation.
- •Patient has a known sensitivity to materials in the device.
结局指标
主要结局
2-Year Knee Society Score
时间窗: 2 years
Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
6-Week Knee Society Score
时间窗: 6 weeks
Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
4-Month Knee Society Score
时间窗: 4 months
Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
1-year Knee Society Score
时间窗: 1 year
Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
次要结局
- 2-year X-rays(2 years)
- 6-Week X-rays(6 weeks)
- 4-month X-rays(4 months)
- 1-year X-rays(1 year)
- 1-year Functional Testing(1 year)
- 6-week Functional Testing(6 weeks)
- 4-month Functional Testing(4 months)
- 2-year Functional Testing(2 years)
- 2-year Patient Surveys(2 years)
研究者
Nancy Parks
Knee Project Director
Anderson Orthopaedic Research Institute