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

Sponsor

University of Wasit (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04980105

Collaborator

(none)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Biological: Platelet-rich plasma Drug: Hyaluronic acid Drug: Methylprednisolone acetate injectable suspension (DEPO-MEDROL®)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A total of 150 participants fulfilling the inclusion criteria, patients were randomly assigned into three groups by a computer-based protocol. The patients were separated into three groups according to the type of treatment administered.A total of 150 participants fulfilling the inclusion criteria, patients were randomly assigned into three groups by a computer-based protocol. The patients were separated into three groups according to the type of treatment administered.

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 2, 2020

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Timed Up and Go test (TUG) [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
Visual Analogue Scale (VAS) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)