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

NCT04198467 | Completed Phase 2 DMC

• 1 other identifier: HimanshuBansalF
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis

Keywords

Platelet rich plasma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• changes in joint space width

  baseline and at 12months

• changes in cartilage thickness as assessed by ultrasonically.

  baseline ,6 months and at 12 months

Study Arms (2)

PRP (100billion platelets)

EXPERIMENTAL

platelet rich plasma having 100 billion platelets in 10 ml plasma prepared from 60 ml blood

Biological: Platelet rich plasma

hyaluronic acid

PLACEBO COMPARATOR

Four ml of high-molecular-weight hyaluronic acid (HMWHA) with a concentration of 22mg/ml

Drug: Hyaluronic Acid

Interventions

Platelet rich plasma BIOLOGICAL

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

Also known as: PRP

PRP (100billion platelets)

Hyaluronic Acid DRUG

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

Also known as: SYNVISC

hyaluronic acid

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Himanshu Bansal Foundation: lead

Related Publications (3)

• 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 29.

  PMID: 25925602 RESULT

• 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: 10.1186/s12891-016-0920-3.

  PMID: 26861957 RESULT

• 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 Osteoarthritis. Am J Sports Med. 2017 Feb;45(2):339-346. doi: 10.1177/0363546516665809. Epub 2016 Oct 21.

  PMID: 28146403 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid; hylan

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• himanshu bansal, ms

  anupam hospital rudrapur uttrakhand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Hyaluronic acid as placebo both patient and investigator blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 13, 2019
• Study Start: October 21, 2014
• Primary Completion: April 15, 2016
• Study Completion: July 10, 2016
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be always available to anyone interested
• Access Criteria: Anyone interested, Researcher ,Patient or Institute can access data anytime.