Predictors of Early Success From Circumferential Compression STITCH Meniscal Repairs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Reoperation Rate
研究概览
简要总结
This is a retrospective study of meniscal tear repairs at least one-year post repair status. All patients were treated with Ceterix NovoStitch devices. The primary objectives of this study are to assess the clinical repair success rate via reoperation and PROs at greater than 12 months.
详细描述
The study is a retrospective, non-randomized, single-group assignment, open-label study of repairs of meniscal tears status post repair. The following clinical efficacy endpoints will be evaluated at greater than 12 months:
- Reoperation rate
- Validated patient-reported outcomes measures
- Contribution of the following retrospective covariates on failure and outcomes when available: Type of tear, Location of tear (lateral versus medial), Chronicity of symptoms, Nature of tear (degenerative versus traumatic), Length of tear, Patient age, Patient gender, Length of rehabilitation protocol, Performance of trephination, Inclusion of biologic enhancement, Meniscal repair alone versus meniscal repair combined with ACL reconstruction.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to give consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements, local regulations, and Health Insurance Portability and Accountability Act (HIPAA) Authorization (or equivalent if locally applicable)
- •In the opinion of the Investigator are able to comply with study-required follow-up
排除标准
- •Post-operative interval <1year
- •Concurrent bony fractures
- •Post-operative reinjury (except the meniscus)
- •Pre-operative arthritis grade 3 or higher on modified outerbridge
- •Knee surgery prior to meniscus repair surgery
- •Any kind of infection
结局指标
主要结局
Reoperation Rate
时间窗: January 2015-February 2016
Data provided by patients
Contribution of the following retrospective covariates on failure and outcomes when available
时间窗: January 2015-February 2016
Type of tear Location of tear (lateral versus medial), Chronicity of symptoms, Nature of tear (degenerative versus traumatic), Length of tear, Patient age, Patient gender, Length of rehabilitation protocol, Performance of trephination, Inclusion of biologic enhancement, Meniscal repair alone versus meniscal repair combined with ACL reconstruction
Validated patient-reported outcomes measures
时间窗: January 2015-February 2016
IKDC Subjective
次要结局
未报告次要终点