NCT02412163已完成不适用
A Multicenter Study of Patients Treated With the Ellipse Technologies Intramedullary High Tibial Osteotomy (IM HTO) Nail System for Osteoarthritis and Varus Malalignment of the Knee
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 11
- 主要终点
- Weight-Bearing Line at Final Correction within ±5, 10, and 15% of Baseline Target
研究概览
简要总结
This study further evaluates the safety profile and efficacy of the Ellipse IM HTO Nail system in subjects with osteoarthritis and varus malalignment of the knee. All subjects will receive treatment with the Ellipse IM HTO Nail System and followed for six months.
详细描述
The Ellipse IM HTO Nail is intended for open wedge proximal tibial osteotomies. The Ellipse IM HTO Nail is an intramedullary nail that operates on the principles of distraction osteogenesis.
The Ellipse IM HTO Nail is used in valgizing HTO procedures to correct varus malalignment. The Ellipse IM HTO Nail is surgically placed in the intramedullary canal of the tibia. It is lengthened telescopically using the non-invasive external remote control.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has standing varus malalignment benefitting from high tibial osteotomy correction
- •Patient is diagnosed with current osteoarthritis of the knee
- •Patient is eighteen years of age or greater
- •Patient is a candidate to be implanted with an Ellipse IM HTO System
- •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
- •Patient understands and accepts the obligation to comply with the required follow-up visits and is logistically able to meet all study requirements
- •Patient signs informed consent for the use of their personal private data
排除标准
- •Patient declines to sign informed consent for the use of their personal private data
- •Varus deformity greater than 10°
- •Flexion contracture greater than 15°
- •Knee flexion under 90°
- •Medial/lateral tibial subluxation over 1 cm
- •Medial bone loss of over 3 mm
- •Inflammatory arthritis
- •Arthritis in the lateral compartment
- •Patella baja
- •Weight over 114 kg
- •Severe patellofemoral symptoms
- •Unaddressed ligamentous instability
- •Fixed flexion contracture
- •Known or suspected osteoporosis or osteopenia based on medical history and radiographic images
- •Current use of nicotine products.
- •Requires other surgical procedures at the time of the HTO surgery
结局指标
主要结局
Weight-Bearing Line at Final Correction within ±5, 10, and 15% of Baseline Target
时间窗: Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required)
次要结局
- Absolute Difference in Weight-Bearing Line Final Target versus Actual at Final Consolidation(Week 6 (Considered the Final Correction Visit unless additional visits are required), Month 6 (Considered the Final Consolidation Visit unless additional visits are required))
- Absolute Difference in Weight-Bearing Line Baseline Target versus Final Target(Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required))
- Change in Tibial Slope Angle Baseline versus Final Correction(Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required))
- Change in Tibial Slope Angle Baseline versus Final Consolidation(Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required))
- Change in Hip-Knee-Ankle Angle Baseline versus Final Correction(Pre-Op, Week 6 (Considered the Final Correction Visit unless additional visits are required))
- Time to Full Weight-Bearing(Week 2, Week 4, Week 6, Month 3, Month 6)
- Change in Hip-Knee-Ankle Angle Baseline versus Final Consolidation(Pre-Op, Month 6 (Considered the Final Consolidation Visit unless additional visits are required))
研究者
研究点 (11)
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