Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis

July 17, 2021 updated by: Usama Al-Sari, University of Wasit

Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis, Which is Better? A Prospective Study of a Single-blind Randomized Control Trial RCT From the Iraqi Population

To assess if there are any differences among platelet-rich plasma, hyaluronic acid, and corticosteroid knee intra-articular injection regarding function and pain.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Wasit, Iraq
        • University of Wasit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient aged 35-65 years old
  • Patient with knee pain that had been continuing for at least 12 months with no relief using anti-inflammatory medications and that deteriorated with weight-bearing
  • Knee osteoarthritis that classified as mild-moderate or moderate-severe (Kellgren-Lawrence Grade 2, 3, or 4)

Exclusion Criteria:

  • Age > 65 years
  • The recent history of knee trauma
  • Autoimmune rheumatic diseases
  • Accompanying severe hip OA
  • Thrombocytopenia or other blood diseases
  • Immunosuppressive or anticoagulant treatment
  • The invasive procedure applied to the knee
  • Intra-articular steroid injection to the knee within the previous 12 months
  • Previous joint infection
  • Uncontrolled systemic diseases such as diabetes or hypertension, and cancer
  • Excessive varus/valgus knee deformity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Platelet-rich plasma arm
Biological: Platelet-rich plasma
Two intra-articular injections of autologous platelets-rich plasma (PRP) in two weeks intervals between the first and the second injection.
Active Comparator: Hyaluronic acid arm
Drug: Hyaluronic acid
Two intraarticular injections of hyaluronic acid (60 mg) in two weeks intervals between the first and the second injection
Active Comparator: Methylprednisolone acetate arm
Drug: Methylprednisolone acetate injectable suspension (DEPO-MEDROL®)
Single methylprednisolone acetate intraarticular injection (DEPO-MEDROL® pfizer 80 mg) mixed with 3cc of (xylocaine 2% concentration)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go test (TUG)
Time Frame: 18th months
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees
18th months
Visual Analogue Scale (VAS)
Time Frame: 18th months
The VAS uses a straight 10 centimeter line with one end being 'no pain' and on the other end the 'worst imaginable pain'. The patient chooses a spot on the line then places a perpendicular line to indicate their pain level
18th months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wasit

Investigators

  • Principal Investigator: Usama A Al-Sari, PhD, UOW

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2020

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

July 7, 2021

First Submitted That Met QC Criteria

July 17, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 17, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOW/MS102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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