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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04980105
• Other study ID #: UOW/MS102
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 2, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: July 2021
• Source: University of Wasit
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: October 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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-in?ammatory 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Drug:
• Hyaluronic acid
Two intraarticular injections of hyaluronic acid (60 mg) in two weeks intervals between the first and the second injection
• Methylprednisolone acetate injectable suspension (DEPO-MEDROL®)
Single methylprednisolone acetate intraarticular injection (DEPO-MEDROL® pfizer 80 mg) mixed with 3cc of (xylocaine 2% concentration)

Locations

Country	Name	City	State
Iraq	University of Wasit	Wasit

Sponsors (1)

Lead Sponsor	Collaborator
University of Wasit

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed Up and Go test (TUG)	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
Primary	Visual Analogue Scale (VAS)	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