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

NCT04980105 | Unknown Phase 3 FDA Drug

• 1 other identifier: UOW/MS102
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Platelet-rich plasma arm

EXPERIMENTAL

Biological: Platelet-rich plasma

Hyaluronic acid arm

ACTIVE COMPARATOR

Drug: Hyaluronic acid

Methylprednisolone acetate arm

ACTIVE COMPARATOR

Drug: Methylprednisolone acetate injectable suspension (DEPO-MEDROL®)

Interventions

Platelet-rich plasma BIOLOGICAL

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

Platelet-rich plasma arm

Hyaluronic acid DRUG

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

Hyaluronic acid arm

Methylprednisolone acetate injectable suspension (DEPO-MEDROL®) DRUG

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

Methylprednisolone acetate arm

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wasit: lead

Study Sites (1)

University of Wasit

Wāsiţ, Iraq

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid; Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Usama A Al-Sari, PhD

  UOW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer of Rheumatology M.B.,Ch.B, MSc , PhD

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 28, 2021
• Study Start: March 2, 2020
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

IR (1)