Post Market, Longitudinal Data Collection Study of DeNovo NT for Articular Cartilage Defects of the Knee
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 15
- 主要终点
- Mean scores from patient-reported clinical outcome surveys
研究概览
简要总结
The purpose of this study is to evaluate the long-term outcomes of DeNovo NT, a tissue product used for the repair of cartilage damage in the knee. This product has been on the market since 2007 and implanted in more than 10,000 patients around the country.
详细描述
Knee cartilage injury is a major cause of pain and functional impairment in young to middle age adults, and can lead to progressive joint degeneration. Adult cartilage has little regenerative capacity and many of the current treatment options have limited or unknown durability. DeNovo NT is an allogeneic tissue graft, prepared from donated juvenile cartilage, which has been shown to have a higher chondrogenic potential than adult cartilage. The graft involves a single surgery with no need for scaffolds, flaps or donor-site morbidity. This study will follow the long-term outcomes and durability of DeNovo NT in patients grafted with this product in the knee, for up to five years. It will enroll subjects prospectively (at the time of surgery) and retrospectively (those who have been previously implanted). Data will be collected on patient-reported outcomes, results of knee examinations, and reoperations and revisions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Has a contained articular cartilage lesion(s) of the knee or Osteochondritis Dissecans OCD lesion(s) of the knee for which arthroscopic or surgical intervention is warranted, OR Has had prior treatment with DeNovo NT for a contained articulare cartilage lesion(so of the knee or Osteochondritis Dissecans OCD lesion(s) of the knee
- •Has voluntarily signed the IRB approved Informed Consent
- •Is of stable health and is able to undergo surgery
- •Is male or female over the age of 18 years
- •Is physically and mentally willing and able to comply with post-operative rehabilitation and routinely scheduled clinical visits
排除标准
- •Displays a high surgical risk as determined by the investigative surgeon
- •Is pregnant or breast-feeding
- •Has a clinically diagnosed autoimmune disease
- •Has an active joint infection or history of chronic joint infection at the surgical site
- •Has damage to the subchondral bone that has not/will not be repaired prior to DeNovo NT treatment
结局指标
主要结局
Mean scores from patient-reported clinical outcome surveys
时间窗: 5 years
次要结局
- Incidence of reoperations and revision surgeries(5 Years)