Prospective Data Collection From the Stryker Biotech Pivotal IDE Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

Olympus Biotech Corporation0 个研究点目标入组 202 人开始时间: 2007年5月最近更新: 2011年6月10日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Olympus Biotech Corporation
入组人数: 202
主要终点: Evidence of bone by CT scan

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study is to provide additional data to support the safety and efficacy of OP-1 Putty as a replacement for autograft in patients undergoing posterolateral spinal fusion.

详细描述

Follow-up study 06-UPLF-01 was a prospective collection of longer-term data on the patient population from pivotal study S01-01US, and was conducted to expand the information regarding efficacy, particularly with regard to radiographic assessment of fusion, as well as the longer-term safety of OP-1 Putty in uninstrumented posterolateral fusion (PLF) as compared to autograft

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•The patient was treated in Stryker Biotech clinical protocol S01-01US (Pivotal IDE study) and not a retreatment failure at the time of completion.
•The patient or legal guardian is willing and able to understand, sign and date the study specific Patient Informed Consent.
•The patient agrees to complete the necessary clinical and radiographic evaluations.

排除标准

•There are no exclusion criteria for participation in this protocol.

结局指标

主要结局

Evidence of bone by CT scan

时间窗: 3+ years post-treatment from the Pivotal study S01-01US

次要结局

Re-assessments of all clinical parameters from S01-01US(3+ years post-treatment from the Pivotal study S01-01US)

研究者

发起方

Olympus Biotech Corporation

申办方类型

Industry

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