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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04198467
• Other study ID #: HimanshuBansalF
• Status: Completed
• Phase: Phase 2
• Start date: October 21, 2014
• Est. completion date: July 10, 2016

Study information

• Verified date: December 2019
• Source: Dr. Himanshu Bansal Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 10, 2016
• Est. primary completion date: April 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Platelet rich plasma
Platelet rich plasma : 100 billion platelets in 10 ml of plasma(PRP) administered intra-articular

Drug:
• Hyaluronic Acid
Hyaluronic acid :Four ml of high-molecular-weight hyaluronic acid with a concentration of 22mg/ml injected intra-articular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Himanshu Bansal Foundation

References & Publications (3)

Cole BJ, Karas V, Hussey K, Pilz K, Fortier LA. Hyaluronic Acid Versus Platelet-Rich Plasma: A Prospective, Double-Blind Randomized Controlled Trial Comparing Clinical Outcomes and Effects on Intra-articular Biology for the Treatment of Knee Osteoarthriti — View Citation

Paterson KL, Nicholls M, Bennell KL, Bates D. Intra-articular injection of photo-activated platelet-rich plasma in patients with knee osteoarthritis: a double-blind, randomized controlled pilot study. BMC Musculoskelet Disord. 2016 Feb 9;17:67. doi: 10.11 — View Citation

Riboh JC, Saltzman BM, Yanke AB, Fortier L, Cole BJ. Effect of Leukocyte Concentration on the Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis. Am J Sports Med. 2016 Mar;44(3):792-800. doi: 10.1177/0363546515580787. Epub 2015 Apr 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in womac score	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	baseline,1 month,3 months,6 months, and 1year
Primary	changes in cartilage thickness as assessed on 1.5 T MRI	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.	baseline and at one year
Secondary	changes in joint space width	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)	baseline and at 12months
Secondary	changes in cartilage thickness as assessed by ultrasonically.	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.	baseline ,6 months and at 12 months