To Evaluate the Optimum Dose of Platelet Rich Plasma in Knee Osteoarthritis and Compare Efficacy With Hyaluronic Acid

Phase 2

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Biological: Platelet rich plasma; Drug: Hyaluronic Acid

• Registration Number: NCT04198467
• Lead Sponsor: Dr. Himanshu Bansal Foundation

Brief Summary

Randomized, Double-blind, 12-month, placebo-controlled study was conducted on 100 outpatients . Intervention platelet rich plasma( PRP) prepared from 60 ml of blood by adding novel step of filtration to manual centrifuge step to achieve 7 times concentration. the efficacy was compared with administration of hyaluronic acid. Subjective Womac scores ,6 min pain free walking distance as well objective assessments MRI ,synovial fluid assessments were made out .Absolute counts of platelets as dose was evaluated to be effective in alleviating symptoms in early knee OA.

Detailed Description

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 Timeline

• Study Start: 2014-10-21
• Primary Completion: 2016-04-15
• Study Completion: 2016-07-10
• Status Verified: 2019-12
• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-12
• Last Update Submitted: 2019-12-12
• Study First Posted: 2019-12-13
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Outpatients who fulfilled the clinical and radiological criteria set by the American College of Rheumatology for the diagnosis of symptomatic primary knee OA, with pain Visual Analogue Scale (VAS) score of >3 in the previous month. In cases where both the knees were symptomatic, the knee which was comparatively more painful was considered.

Exclusion Criteria

1. Evidence of secondary knee OA because of injury, inflammatory or metabolic rheumatic disease, or osteonecrosis;
2. Prior intra-articular injection of hyaluronic acid (HA), including lavage and corticosteroids within the previous three months;
3. Severe knee OA, with JSW <1 mm, or surgery required on the evaluated knee in the year
4. Patients with clinically significant systemic disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRP (100billion platelets)	Platelet rich plasma	platelet rich plasma having 100 billion platelets in 10 ml plasma prepared from 60 ml blood
hyaluronic acid	Hyaluronic Acid	Four ml of high-molecular-weight hyaluronic acid (HMWHA) with a concentration of 22mg/ml

Primary Outcome Measures

Name	Time	Method
changes in womac score	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	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.

Secondary Outcome Measures

Name	Time	Method
changes in joint space width	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.	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.