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

NCT ID: NCT04980105

Last Updated: 2021-07-28

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-02

Study Completion Date

2021-10-01

Brief Summary

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

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Platelet-rich plasma arm

Group Type EXPERIMENTAL

Platelet-rich plasma

Intervention Type BIOLOGICAL

Two intra-articular injections of autologous platelets-rich plasma (PRP) in two weeks intervals between the first and the second injection.

Hyaluronic acid arm

Group Type ACTIVE_COMPARATOR

Hyaluronic acid

Intervention Type DRUG

Two intraarticular injections of hyaluronic acid (60 mg) in two weeks intervals between the first and the second injection

Methylprednisolone acetate arm

Group Type ACTIVE_COMPARATOR

Methylprednisolone acetate injectable suspension (DEPO-MEDROL®)

Intervention Type DRUG

Single methylprednisolone acetate intraarticular injection (DEPO-MEDROL® pfizer 80 mg) mixed with 3cc of (xylocaine 2% concentration)

Interventions

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Platelet-rich plasma

Two intra-articular injections of autologous platelets-rich plasma (PRP) in two weeks intervals between the first and the second injection.

Intervention Type BIOLOGICAL

Hyaluronic acid

Two intraarticular injections of hyaluronic acid (60 mg) in two weeks intervals between the first and the second injection

Intervention Type DRUG

Methylprednisolone acetate injectable suspension (DEPO-MEDROL®)

Single methylprednisolone acetate intraarticular injection (DEPO-MEDROL® pfizer 80 mg) mixed with 3cc of (xylocaine 2% concentration)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wasit

OTHER

Sponsor Role lead

Responsible Party

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Usama Al-Sari

Senior Lecturer of Rheumatology M.B.,Ch.B, MSc , PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Usama A Al-Sari, PhD

Role: PRINCIPAL_INVESTIGATOR

UOW

Locations

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University of Wasit

Wāsiţ, , Iraq

Site Status

Countries

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Iraq

Other Identifiers

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UOW/MS102

Identifier Type: -

Identifier Source: org_study_id

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