What side effects are associated with this type of intervention?

Corticosteroids, used for their anti-inflammatory properties, can cause cartilage damage, increased risk of joint infection, and systemic effects like elevated blood sugar and weakened immune response with repeated use. Platelet-rich plasma (PRP) injections, aimed at tissue regeneration and healing, typically have minor side effects such as pain, bleeding, tenderness, swelling, and bruising at the injection site, along with a risk of local infection.

What prior FDA approvals exist?

Corticosteroids, such as triamcinolone acetonide, have been FDA-approved for intra-articular injections to manage pain and inflammation associated with osteoarthritis. These injections are commonly used for short-term relief in patients with moderate to severe symptoms. Platelet-rich plasma (PRP) therapy, which involves injecting a concentration of a patient's own platelets to promote tissue regeneration and healing, is not specifically FDA-approved for osteoarthritis but is used off-label in clinical practice. PRP is considered a safe treatment option with minimal regulation, although its efficacy for osteoarthritis remains under investigation.

What other types of research exist?

Promising novel alternatives to corticosteroids and PRP for osteoarthritis patients in 2024 include mesenchymal stem cell (MSC) therapy and the combined use of hyaluronic acid (HA) with PRP. MSC therapy has shown potential in treating knee osteoarthritis, although more large clinical trials are needed to confirm its efficacy. The combination of HA and PRP has also demonstrated positive results in clinical trials, offering a synergistic effect for symptomatic relief in early OA.

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PRP vs Corticosteroids for Knee Osteoarthritis

Phase 1 & 2

Recruiting

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Summary

This trial compares two types of injections to treat knee osteoarthritis. It aims to see how each affects pain, function, and joint health. The study focuses on adults with knee osteoarthritis to find better long-term treatment options. One type of injection aims to address the underlying causes of osteoarthritis and has the potential to improve both symptoms and joint structure.

Who is the study for?

This trial is for people over 40 with moderate to severe knee osteoarthritis, but not at the end-stage. They must have a specific level of joint damage (KL grade 2-3) and be able to receive corticosteroid or biological treatments. Pregnant individuals, those with previous knee surgery, allergies to injections, or currently in another trial cannot participate.

What is being tested?

The study compares the effects of two types of knee injections: platelet-rich plasma and corticosteroid (Triamcinolone Acetonide). It measures their impact on pain, function, and joint cartilage changes through surveys and analysis of blood, urine, and synovial fluid samples from participants.

What are the potential side effects?

Potential side effects may include injection site reactions like pain or swelling. Corticosteroids can sometimes cause increased appetite, mood changes or raise blood sugar levels. Platelet-rich plasma's side effects are typically mild but could include tissue damage if improperly administered.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

The change From Baseline in Pain Scores on the Knee Injury and Osteoarthritis Outcome Score-Joint Replacement at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, and 12 months

The change From Baseline in Pain Scores on the Visual Analog Scale at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, and 12 months

The change From Baseline in Scores on the UCLA Activity Score at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, and 12 months

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Platelet-rich PlasmaExperimental Treatment1 Intervention

An injection at the initial visit of approximately 4-6 mL of PRP

Group II: SteroidActive Control1 Intervention

A 6mL injection at the initial visit of triamcinolone 40 mg/1 mL (Kenalog) with 5 mL of 1% lidocaine

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Corticosteroids reduce inflammation by inhibiting inflammatory pathways and decreasing the production of inflammatory mediators, providing short-term pain relief and improved joint function. Platelet-rich plasma (PRP) promotes tissue regeneration and healing by delivering a high concentration of growth factors to the affected area, enhancing cartilage repair and reducing inflammation. Understanding these mechanisms helps osteoarthritis patients and their healthcare providers choose the most appropriate treatment based on individual symptoms and treatment goals.

Osteoarthritis of the knee - biochemical aspect of applied therapies: a review.Pathophysiology and first-line treatment of osteoarthritis.

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Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor

376 Previous Clinical Trials

628,591 Total Patients Enrolled

11 Trials studying Osteoarthritis

12,760 Patients Enrolled for Osteoarthritis

Vicki Jones, MEd, CCRPStudy DirectorUniversity of Missouri-Columbia

Stacee Baker, MEd, RNStudy DirectorUniversity of Missouri-Columbia

Media Library

Platelet-rich plasma Inj (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05657496 — Phase 1 & 2

Osteoarthritis Research Study Groups: Steroid, Platelet-rich Plasma

Osteoarthritis Clinical Trial 2023: Platelet-rich plasma Inj Highlights & Side Effects. Trial Name: NCT05657496 — Phase 1 & 2

Platelet-rich plasma Inj (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05657496 — Phase 1 & 2

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