The Effect Of Intraarticular Growth Factor Concentrate Injection In Knee Osteoarthritis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1.To assess and compare the functional outcome in patients of Knee Osteoarthritis before each GFC/NS injection and at 6 months and at 9 months and study their effect.
研究概览
简要总结
Patients will be recruited from the OPD after applying ACR criteria & KL Grade II and III on X-RAY KNEE AP/LAT (STANDING) and applying inclusion and exclusion criteria;. Randomization will be done via a computer-generated random sequence and patient will be divided into 2 groups (Group A-GFC; Group B-NS) VAS, WOMAC, Ser. Coll2-1NO2, X-Ray, MRI study{WORMS} Before 1stGFC/NS(Baseline) Intraarticular injection Then USG-guided 1st Intraarticular injection of GFC/NS will be given After 1 month VAS , WOMAC will be taken and USG-guided 2nd GFC/NS Intraarticular injection will be given After 6 month VAS , WOMAC will be taken VAS , WOMAC , Ser. Coll2-1NO2 , X-Ray , MRI study{WORMS} will be taken after 9 months to study the effect
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient of either age group Diagnosed with Osteoarthritis Knee as per American College of Rheumatology (ACR) 2019 criteria.
- •Among the above patients who are diagnosed with Grade II and III Osteoarthritis of the knee joint according to the Kellgren-Lawrence scale are selected.
排除标准
- •1.Any known malignancy 2.Gouty Arthritis /inflammatory arthritis, Secondary Osteoarthritis 3.Active knee infection.
- •4.Disorders of Bleeding 5.Uncontrolled Diabetes Mellitus 6.Ligamentous instability of knee (MRI DIAGNOSED)Â 7.Contraindication to MRI 8.Any history of previous intraarticular steroid injection.
结局指标
主要结局
1.To assess and compare the functional outcome in patients of Knee Osteoarthritis before each GFC/NS injection and at 6 months and at 9 months and study their effect.
时间窗: 1,2,6 and 9 months
2.To assess and compare the Radiological outcome with the help of WORMS score and X-Ray in patients of Knee Osteoarthritis and observe the changes at the end of 9 months.
时间窗: 1,2,6 and 9 months
次要结局
- 1.To assess and compare the cartilage degeneration with the help of Biochemical marker Serum Coll2-1NO2 levels at the final follow-up and compared to the baseline serum levels to analyse the effects of both GFC and NS on its level in the body.(1,2,6 and 9 months)
研究者
Dr Amit Saraf
Teerthankar Mahaveer Medical College and Research Centre