To Evaluate the Optimum Dose of Platelet Rich Plasma in Knee Osteoarthritis and Compare Efficacy With Hyaluronic Acid
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|ClinicalTrials.gov Identifier: NCT04198467|
Recruitment Status : Completed
First Posted : December 13, 2019
Last Update Posted : December 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Biological: Platelet rich plasma Drug: Hyaluronic Acid||Phase 2|
Osteoarthritis (OA) causes substantial physical disability that limits a person ability to indulge in daily activities. OA related disability has been affecting millions of older adults throughout the world, and the number has almost doubled in 2019.
Though the process of OA could not be reversed, efficient management strategies could help in minimizing primary pain with physical exercises, surgical procedures, and medications.
Prolonged use of nonsteroidal anti-inflammatory drugs (NSAIDs) has been dramatically associated with mild to severe side effects, limiting its continuous use. Chondro-protective agents (CPAs) have been proven to provide only minimal symptomatic benefit. Platelet-rich plasma (PRP) has emerged as a supreme therapy in OA knee however exact dose ,preparation and duration of benefit still remains unclear.
Study was undertaken to demonstrate the potential of leukocyte depleted PRP in cartilage repair of knee OA using WOMAC scores as subjective assessment tool.
Our research also evaluated objective criteria ing joint space width (JSW),cartilage thickness on MRI, Ultrasound that would improve knee joint function in patients with knee OA.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
182 patients screened, 100 were considered eligible for the study and were randomized. The most common reason for exclusion was either the lack of radio graphic evidence of knee OA or the presence of severe disease with JSW less than 2 mm at the narrowest point.
Out of the 100 randomized patients, roughly equal numbers, six patients in PRP and 7 in placebo, did not complete the study. Reasons for withdrawal were personal,inefficacy, or adverse event as an increase in pain.
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Hyaluronic acid as placebo both patient and investigator blinded|
|Official Title:||Randomized Controlled Study to Compare Safety and Efficacy of Intra Articular Administration of Platelet Rich Plasma Versus Hyaluronic Acid as Placebo in Patients With Osteoarthritis of Knee|
|Actual Study Start Date :||October 21, 2014|
|Actual Primary Completion Date :||April 15, 2016|
|Actual Study Completion Date :||July 10, 2016|
Experimental: PRP (100billion platelets)
platelet rich plasma having 100 billion platelets in 10 ml plasma prepared from 60 ml blood
Biological: Platelet rich plasma
Platelet rich plasma : 100 billion platelets in 10 ml of plasma(PRP) administered intra-articular
Other Name: PRP
Placebo Comparator: hyaluronic acid
Four ml of high-molecular-weight hyaluronic acid (HMWHA) with a concentration of 22mg/ml
Drug: Hyaluronic Acid
Hyaluronic acid :Four ml of high-molecular-weight hyaluronic acid with a concentration of 22mg/ml injected intra-articular
Other Name: SYNVISC
- changes in womac score [ Time Frame: baseline,1 month,3 months,6 months, and 1year ]WOMAC, a widely used measure to assess patients' pain, joint mobility, and physical disability evaluates three dimensions, pain, stiffness, and physical function, with 5, 2, and 17 questions, respectively. The total maximum score is 96 and minimum, 0
- changes in cartilage thickness as assessed on 1.5 T MRI [ Time Frame: baseline and at one year ]Using the 1.5-T field strength with standard MRI acquisition protocols, MRI was performed of each joint individually in coronal, sagittal, and transverse planes. The maximum thickness of the cartilage at posterior,meniscal and patellar level measured at the midsagittal plane through the medial condyle was considered. The medial femoral cartilage of the affected knee was chosen for measurement.
- changes in joint space width [ Time Frame: baseline and at 12months ]Patients were radiographed in a weight-bearing position, joints fully extended, standing at 1 m from the X-ray source20. The width was measured at the narrowest point of the Joint (JSW)
- changes in cartilage thickness as assessed by ultrasonically. [ Time Frame: baseline ,6 months and at 12 months ]Having the patients sit with flexed knees,The articular cartilage of the medial femoral condyle was evaluated with a starting point at the level of intercondylar notch to the medial border of the medial condyle by an ultrasound.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04198467
|Principal Investigator:||himanshu bansal, ms||anupam hospital rudrapur uttrakhand|