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

Phase 3

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Methylprednisolone acetate injectable suspension (DEPO-MEDROL®); Biological: Platelet-rich plasma; Drug: Hyaluronic acid

• Registration Number: NCT04980105
• Lead Sponsor: University of Wasit

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-02
• Status Verified: 2021-07
• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-17
• Last Update Submitted: 2021-07-17
• Study First Posted: 2021-07-28
• Last Update Posted: 2021-07-28
• Primary Completion: 2021-09-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylprednisolone acetate arm	Methylprednisolone acetate injectable suspension (DEPO-MEDROL®)	-
Platelet-rich plasma arm	Platelet-rich plasma	-
Hyaluronic acid arm	Hyaluronic acid	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Wasit; 🇮🇶 Wasit, Iraq