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

NCT ID: NCT04198467

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-21

Study Completion Date

2016-07-10

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis

Keywords

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Platelet rich plasma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Hyaluronic acid as placebo both patient and investigator blinded

Study Groups

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PRP (100billion platelets)

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

Group Type EXPERIMENTAL

Platelet rich plasma

Intervention Type BIOLOGICAL

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

hyaluronic acid

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

Group Type PLACEBO_COMPARATOR

Hyaluronic Acid

Intervention Type DRUG

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

Interventions

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Platelet rich plasma

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

Intervention Type BIOLOGICAL

Hyaluronic Acid

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

Intervention Type DRUG

Other Intervention Names

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PRP SYNVISC

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Himanshu Bansal Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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himanshu bansal, ms

Role: PRINCIPAL_INVESTIGATOR

anupam hospital rudrapur uttrakhand

References

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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.

Reference Type RESULT
PMID: 25925602 (View on PubMed)

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.

Reference Type RESULT
PMID: 26861957 (View on PubMed)

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.

Reference Type RESULT
PMID: 28146403 (View on PubMed)

Other Identifiers

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HimanshuBansalF

Identifier Type: -

Identifier Source: org_study_id