Post Market, Longitudinal Data Collection Study of Articular Cartilage Lesions in the Ankle Treated With DeNovo(R) NT Natural Tissue Graft
试验速览
- 阶段
- 不适用
- 入组人数
- 205
- 试验地点
- 8
- 主要终点
- Mean scores from patient-reported clinical outcome surveys
研究概览
简要总结
The purpose of this post-market clinical study is to collect long-term outcomes for DeNovo NT Graft treatment of articular cartilage lesions in the ankle in a standard clinical setting. Outcomes to be assessed include pain, function, activity levels and healthcare resource use.
详细描述
Articular cartilage lesions in the ankle can cause significant pain and loss of function for young to middle age adults. There are several treatment options for symptomatic articular cartilage injuries depending on a patient's age, symptoms and duration of complaints in addition to the size and condition of the lesion. DeNovo NT Natural Tissue Graft is comprised of fresh particulated juvenile cartilage pieces that are secured inside articular cartilage lesions using fibrin adhesive. DeNovo NT Graft was developed due to the current need for expanded treatment options for the treatment of cartilage lesions, especially large lesions.
This post-market, multicenter, longitudinal data collection study was established to collect clinical outcomes of subjects implanted with DeNovo NT Graft. Data may be obtained either retrospectively or prospectively from patients implanted or to be implanted with DeNovo NT Graft for the treatment of lesion in the ankle. Data to be collected include details of the operative procedure as well as subject pain, function, activity levels, and healthcare resource use through a five year post-operative follow-up period.
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 an articular cartilage lesion(s) in the ankle for which arthroscopic or surgical intervention with DeNovo NT Graft is warranted or has had prior treatment with DeNovo NT Graft for an articular cartilage lesion(s) in the ankle
- •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 at the time of consent
- •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 medical history that would likely make the subject unreliable for the study, or any combination of variables in the investigator's judgment that should exclude a potential subject
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)