NL-OMON45063已完成3 期
Phase III, pivotal, multicentre, randomised, double-blind controlled Study to evaluate the Efficacy and Safety of Autologous Osteoblastic Cells (PREOB®) Implantation in Early Stage Non Traumatic Osteonecrosis of the Femoral Head. - Efficacy and safety of autologous bone transplant for femoral head necrosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
Trial ended prematurely
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 18 to 70 years old, diagnosed with:
- •- an ARCO stage I osteonecrosis with the sum of coronal and sagittal necrotic angles superior to 190 degrees which is symptomatic (pain * 20 mm on the WOMAC® VA3.1 pain subscale during the 48 hours preceding the screening)
- •- an ARCO stage II osteonecrosis with the sum of coronal and sagittal necrotic angles superior to 190 degrees which can be either symptomatic or asymptomatic
- •- an ARCO stage II osteonecrosis with the sum of coronal and sagittal necrotic angles inferior to 190 degrees which is symptomatic (pain * 20 mm on the WOMAC® VA3.1 pain subscale during the 48 hours preceding)
排除标准
- •ARCO stage III and IV osteonecrosis of the femoral head on the hip which is evaluated, and confirmed by conventional X-ray and and MRI of the hip.
- •Osteoarthritis on the hip. Bone fracture that might interfere with study evaluation.
研究者
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