ACTRN12613000421730已完成未知
A Multi-Center, Single Arm Pilot Study to assess improvement in Pain and Function in Patients with medial compartment Knee OA treated with the KineSpring PEEK System
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
The purpose of this study was to evaluate the improvement in pain and function following implantation of the KineSpring PEEK System in patients with osteoarthritis of the medial compartment of the knee. The PEEK clinical study primary effectiveness endpoint of decrease in pain and function measured by WOMAC at 6 months compared to baseline was met. Overall, seven subjects (7/9, 77.8%) experienced improvement in both WOMAC pain and function scores. In the first 6 months, there were no device-related adverse events. Therefore, the primary safety endpoint was also met.
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
- 25 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Documented diagnosis of primary OA of the target knee made at least 6 months prior to screening, 2.Documented radiographic evidence of medial OA as demonstrated by a Kellgren-Lawrence grade of >=2 (scale 0-4) as assessed by the investigator, 3.Has continued target knee OA pain despite 6 months of conservative treatment prior to surgery, 4. Has pain in the target knee as demonstrated by a minimum score of 40 (scale 0-100) on the KOOS/WOMAC pain domain questions, 5. Aged minimum 25 years, 6. Knee flexion >=90 degrees to <=140 degrees, 7. Weight <300 lbs (136.4kg)
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. Significant OA in lateral or patello-femoral compartment as measured by Kellgren Lawrence grade of 2 or 3, respectively, 4. Significant OA in the contralateral knee likely to necessitate surgical intervention within 12 months of enrollment, 5. Previous joint modifying surgery in the target knee within 12 months prior to planned surgery date such as ligament reconstruction or meniscus repair, cartilage transplantation, and microfracture - a. Arthroscopic surgeries for joint lavage, menisectomy, chondral debridement, and loose body removal are excluded if within 3 months prior to planned surgery date, 6. Previous osteotomy or failed knee joint replacement in the target knee, 7. Tibial-femoral varus or varus alignment >10 degrees, 8. Hyperextension >5degrees, 9. Flexion deformity greater than 10 degrees, 10. Ligamentous laxity, or meniscal instability as assessed by the investigator, 11. Uncontrolled diabetes mellitus, 12. Moderate to severe osteoporosis, 13. Concomitant immunosuppressive therapy, 14. Metabolic disorders which may impair bone formation, 15. Osteomalacia, 16. Distant foci of infections which may spread to the implant site, 17. Rapid joint destruction, marked bone loss or bone resorption apparent on x-ray, 18. Vascular insufficiency, muscular atrophy, neuromuscular disease, 19. Any significant medical condition or other factor that the Investigator feels would interfere with study participation, 20. Pregnancy or lactation, 21. Prisoners
研究者
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