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临床试验/NCT00659880
NCT00659880已完成不适用

Clinical Application of BioCleanse Meniscus Registry

RTI Surgical1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2008年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
RTI Surgical
入组人数
9
试验地点
1
主要终点
Knee Injury and Osteoarthritis Outcome Score (KOOS)

研究概览

简要总结

This study will follow patients after routine surgery of a meniscal allograft transplant.

详细描述

The BioCleanse meniscus is available to to all orthopedic surgeons for transplantation. The purpose of this registry is to allow close monitoring of a subgroup of patients receiving the BioCleanse Meniscus. All patients who have selected a BioCleanse Meniscus for their Meniscal Allograft transplant will be asked to join the registry. Outcomes will be measured by subjective subject questionnaires as well as X-rays and MRI.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All patients, up to 10 who have selected a BioCleanse Meniscus transplant

排除标准

  • Anyone not eligible for a meniscal transplant

结局指标

主要结局

Knee Injury and Osteoarthritis Outcome Score (KOOS)

时间窗: 60 months

The score is an index score from 0 to 100, with 0 representing extreme problems and 100 representing no problems.

次要结局

  • MRI Assessments(12 months)

研究者

发起方
RTI Surgical
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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