ACTRN12609001068257已完成未知
A Multi-Center, Open-Label, Interventional Study to assess pain relief in Patients with Medial Compartment Knee Osteoarthritis (OA) treated with the KineSpring(Registered Trademark) System
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- Moximed, Inc
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 30 Years 至 o limit（—）
- 性别
- All
入选标准
- •Male or Female Subjects at least 30 years of age with a minimum 3 month history of primary OA in target knee, with radiographic evidence of OA, continuing pain despite conservative treatment, minimum WOMAC score (Q –A1) of 2, maximum weight of 300 pounds or 136.4 kg.
排除标准
- •1. Active infection, sepsis, osteomyelitis or history of septic arthritis in any
- •Joint, 2. Rheumatoid arthritis or other forms of inflammatory joint disease, 3. Modified Kellgren-Lawrence Numerical grading System of grade IV in the patello-femoral compartment of the target, 4. Previous surgery in the target knee within the 3 months prior to screening, 5. Varus alignment >10 degrees, 6. Ligamentous laxity, or meniscal instability as assessed by the investigator, 7. Uncontrolled diabetes mellitus, 8. Moderate to severe osteoporosis, 9. Concomitant immunosuppressive therapy, 10. Metabolic disorders which may impair bone formation, 11. Osteomalacia
- •12. Distant foci of infections which may spread to the implant site, 13. Rapid joint destruction, marked bone loss or bone resorption apparent on x-ray, 14. Vascular insufficiency, muscular atrophy, neuromuscular disease, 15. Incomplete or deficient soft tissue surrounding the knee, 16. Flexion deformity greater than 15 degrees, 17. Pregnancy or lactation
- •18. Prisoners
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