NL-OMON37100撤回3 期
A pivotal Phase IIb/III, multicentre, randomised, open, controlled study on the efficacy and safety of autologous osteoblastic cells (PREOB®) implantation in non-infected hypotrophic non-union fractures. - PREOB-NU3
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •men and women aged between 18 and 65
- •diagnosed with non-infected hypotrophic non union fractures as confirmed by X-ray
排除标准
- •Fracture interline > 1cm
- •Open fracture with septic local infection
- •Insufficient fracture stability
- •osteosynthesis material other than intramedullary nails or plates
- •bone infection
- •open fracture
- •multifocal fracture/ non-union
- •non-union or non consolidated fracture on the neighbouring bone
- •nerve damages or tendon lesion at the non-union fracture site
研究者
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