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临床试验/CTRI/2024/05/068055
CTRI/2024/05/068055尚未招募2 期

Efficacy of intraarticular injection Of autologous platelet rich plasma in patients with knee osteoarthritis

Gandhi medical college1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2024年6月10日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
86
试验地点
1
主要终点
To assess the therapeutic effectiveness of PRP as a intraarticular injection to knee joint for OA patients by Womac scoring

研究概览

简要总结

Osteoarthritis is a degenerative disease involving joint damage, an inadequate healing response and progressive deterioration of the joint architecture the commonly affects the knee joints. The most common conservative management for osteoarthritis is NSAIDS drugs, chondroitin sulfate, glucocorticoid. However these methods have various adverse effect & healing ability of cartilage tissue is not up to the mark.so it can give only short time resolution. • Autologous blood derived products possess much promise in the repair and regeneration of tissue and have important role in inflammation, angiogenesis, cell migration and metabolism in pathological conditions including osteoarthritis • PRP is an autologous mixture of highly concentrated platelets and associated growth factors and other bioactive components produced by centrifugal separation of whole blood that is mostly used in orthopaedic and sports medicine practice to treat bone, tendon and ligament injuries. • PRP may induce a regenerative response by improving the metabolic function of damaged structures • PRP also contains high concentration of growth factors,VEGF,PDGF,TGFbeta • The supra-physiological release of platelet derived growth factors directly at the site of cartilage disease, may stimulate the natural regenerative signalling cascade and enhance the healing of tissue with further mediation of the anti-inflammatory response The Ultimate aim of the study to assess the therapeutic effectiveness of platelet rich plasma as intraarticular knee joint injection for a patients with osteoarthritis by using WOMAC scoring

This study includes the sample size of between 4070 86 patients belong the age group year and history of knee pain more than 3 months hi story of patient was taken in pain clinic and they underwent . Detailed a thorough physical examination. Patient s fulfilling the criteria were explained about treatment modality in detail and informed consent was obtained & their pain sc ore by WOMAC scoring was assessed

P latelet Rich Plasma(PRP) PREPARATION : About 30 ml of patients blood was taken from vials 4.2ml of acid dextrose solution in sterile 5 ml of PRP. antecubital vein and mixed with to get about 3 and it centrifuged telet After centrifuging the concentration of pla patients blood was assessed. Procedure: in PRP and After all those initial preparation, the patient was taken to operating with proper monitoring with pulse oximeter, ECG, non invasive blood pressure through room out the procedure. Two large IV cannula was established and one unit of RL was started in one IV cannula and inj. Ondansetron 4mg IV , inj. Midazolam 1mg IV , inj. Fentanyl 25 mcg was given as antiemetic, anxiolytic, analgesic basis respectively. Patient was lies on his back , exposing slightly flexed the knee joint and the affected knee joint . Routine disinfection was done with iodophor . inj. lignocaine p 2% was infiltrated in to the skin / subcutaneous tissue. And then 3 ml of autologous PRP was administered in the patellofemoral joint space at outer edge of patella and then knee joint was slightly flexed and extended for several times to ma ke sure PRP fully cover the articular surface. After the injection patient was instructed to avoid strenuous same exercise And the procedure was done once in a week for a 3 consecutive week After the 3 shot of PRP injection in 3 consecutive week, the patients WOMAC score was assessed and it was compared with their initial WOMAC scoring.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patient with knee joint swelling/pain for more than 3 months Xray showing degenerative changes.

排除标准

  • Patient refusal or not giving consent Infected knee joint /(Osteomyelitis) Hb<10gm/dl Platelet < 1.5 lakh cells/mm3 Pregnantwomen/breast feeding women Any Hematological disorders like CLL, ALL, AML Rheumatological disorders like RA, SLE Osteoarthritis grade I & IV.

结局指标

主要结局

To assess the therapeutic effectiveness of PRP as a intraarticular injection to knee joint for OA patients by Womac scoring

时间窗: In 3 sitting of injection in gap of 1 week

次要结局

  • Occurrence of side effects and complications(In 3 sitting of injection in gap of 1 week)

研究者

发起方
Gandhi medical college
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Vignesh Rajan

Gandhi medical college, bhopal

研究点 (1)

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