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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
Study Summary
This trial is testing how two injections (corticosteroid and platelet-rich plasma) to treat knee osteoarthritis affect pain/function and what happens in the joint cartilage. There are surveys to complete and blood/urine samples to provide.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in concentration of MCP-1 proinflammatory biomarker from baseline in the serum after intraarticular knee injection of PRP at 1 month, 3 months, and 6 months timeframes
Difference in concentration of MCP-1 proinflammatory biomarker from baseline in the synovial fluid after intraarticular knee injection of PRP at 1 month, and possibly 3 and 6 months timeframes
Difference in concentration of MCP-1 proinflammatory biomarker from baseline in the urine after intraarticular knee injection of PRP at 1 month, 3 months, and 6 months timeframes
Secondary outcome measures
Correlating the change of specific biomarker concentrations with the change of patient-reported outcome scores
Difference in concentration of COMP from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month, and possibly 3 and 6 months timeframes
Difference in concentration of CTX-1 from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month, and possibly 3 and 6 months timeframes
+20 moreTrial 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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Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
362 Previous Clinical Trials
628,044 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had knee surgery to rebuild it.I have moderate or severe knee osteoarthritis but it's not in the end-stage.I cannot have corticosteroid injections due to allergies or bad reactions.I am over 40 and have a knee problem.I am unable to give my consent for treatment.I am younger than 40 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Steroid
- Group 2: Platelet-rich Plasma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum participant number for this clinical research trial?
"Affirmative. The clinicaltrials.gov page for this trial outlines that they are actively looking to enroll 70 patients from 1 location since its initial launch on December 28th 2022 and most recent edit made on August 29th 2023."
Answered by AI
Is there a current availability for participants to join this clinical trial?
"That is correct. According to clinicaltrials.gov, the trial that was initially published on December 28th 2022 and recently updated on August 29th 2023 is now recruiting patients. A total of 70 participants are needed from a single site."
Answered by AI
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