NL-OMON42426已完成4 期
A Multicenter Study of Patients treated with the EllipseTechnologies Intramedullary High Tibial Osteotomy (IM HTO) Nail System for Osteoarthritis and Varus Malalignment of the Knee - Ellipse study
MEDPASS INTERNATIONA0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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
- •1. Patient has standing varus malalignment benefitting from high tibial
- •osteotomy correction
- •2. Patient is diagnosed with current osteoarthritis of the knee
- •3. Patient is eighteen years of age or greater
- •4. Patient is a candidate to be implanted with an Ellipse IM HTO System
- •5. If female of childbearing potential, patient presents with a negative
- •pregnancy test and agrees to employ adequate birth control measures for
- •the duration of the study
- •6. Patient understands and accepts the obligation to comply with the
- •required follow-up visits and is logistically able to meet all study
- •requirements
- •7. Patient signs informed consent for the use of their personal private data
排除标准
- •1. Patient declines to sign informed consent for the use of their personal
- •private data
- •2. Varus deformity greater than 10°
- •3. Flexion contracture greater than 15°
- •4. Knee flexion under 90°
- •5. Medial/lateral tibial subluxation over 1 cm
- •6. Medial bone loss of over 3 mm
- •7. Inflammatory arthritis
- •8. Arthritis in the lateral compartment
- •9. Patella baja
- •10. Weight over 114 kg
- •11. Severe patellafemoral symptoms
- •12. Unaddressed ligamentous instability
- •13. Fixed flexion contracture
- •14. Known or suspected osteoporosis or osteopenia based on medical
- •history and radiographic images
- •15. Current use of nicotine products.
- •16. Requires other surgical procedures at the time of the HTO surgery
研究者
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