Biological Response to Platelet-rich Plasma and Corticosteroid Injections

NCT05657496 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 2092036
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The goal is to determine how two different injections, corticosteroid and platelet-rich plasma, are used to treat patients with knee osteoarthritis may affect a patient's pain and function. Secondarily, the investigators are also interested in knowing how the two types of injections that will be given may affect what happens in the joint cartilage. The participants will receive one of the two injection types at the initial visit. There will be surveys to complete (around 10 questions) about the participants' knee and overall function. The investigators will ask these same questions on seven separate occasions. In addition, the investigators will ask the participants to provide blood and urine samples at our clinic before the first knee injection and before any other injection that is needed over the course of the study. During the injections, synovial fluid will be aspirated from the participants' knee at the initial visit and the one month visit. If the participants decide to go to surgery to help relieve the pain from osteoarthritis at any point during the study, the investigators will collect the material from the participants' knee that would be normally discarded as medical waste. Previous studies have indicated that concentrations of inflammatory and degradative biomarkers in patient serum, urine, and synovial fluid may provide insight into OA pathophysiology. To our knowledge, no study has been performed to assess the impact of intra-articular PRP injection upon fluid concentrations of a comprehensive panel of proposed OA-related biomarkers. In this study, the investigators will evaluate the impact of intra-articular PRP injection upon markers of cartilage matrix turnover, inflammatory mediators, degradative enzymes, inhibitors of degradative enzymes, and markers of bone metabolism in serum, urine, and synovial fluid of knee OA patients.

Conditions

Knee Osteoarthritis

Keywords

Knee Pain; Osteoarthritis; Corticosteroid; Platelet-rich Plasma (PRP)

Outcome Measures

Primary Outcomes (3)

• Difference in concentration of MCP-1 proinflammatory biomarker from baseline in the serum after intraarticular knee injection of PRP at 1 month.

  MCP-1 is a proinflammatory chemokine that recruits monocytes to sites of injury or inflammation. It plays a key role in the immune response and has been implicated in various chronic inflammatory and cardiovascular diseases.

  12 months

• Difference in concentration of MCP-1 proinflammatory biomarker from baseline in the urine after intraarticular knee injection of PRP at 1 month.

  MCP-1 is a proinflammatory chemokine that recruits monocytes to sites of injury or inflammation. It plays a key role in the immune response and has been implicated in various chronic inflammatory and cardiovascular diseases.

  12 months

• Difference in concentration of MCP-1 proinflammatory biomarker from baseline in the synovial fluid after intraarticular knee injection of PRP at 1 month.

  MCP-1 is a proinflammatory chemokine that recruits monocytes to sites of injury or inflammation. It plays a key role in the immune response and has been implicated in various chronic inflammatory and cardiovascular diseases.

  12 months

Secondary Outcomes (23)

• Difference in concentration of RANTES proinflammatory biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.

  12 months

• Difference in concentration of IL-1b proinflammatory biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.

  12 months

• Difference in concentration of IL-6 proinflammatory biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.

  12 months

• Difference in concentration of IL-8 proinflammatory biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.

  12 months

• Difference in concentration of TNF-a proinflammatory biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.

  12 months

Study Arms (2)

Steroid

ACTIVE COMPARATOR

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

Drug: Triamcinolone Acetonide 40 mg/ml Inj, Susp

Platelet-rich Plasma

EXPERIMENTAL

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

Biological: Platelet-rich plasma Inj

Interventions

Triamcinolone Acetonide 40 mg/ml Inj, Susp DRUG

Prepared in clinic by physician or medical staff

Also known as: Corticosteroid injection

Steroid

Platelet-rich plasma Inj BIOLOGICAL

Produced from participant's whole blood venous draw of approximately 15 mL. Prepared by centrifuge in clinical office

Also known as: PRP

Platelet-rich Plasma

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 40 and over, presenting with a knee disorder of at least one knee
• Patients eligible for use of either corticosteroid or biological agent for treatment of moderate or severe (but not end-stage) knee osteoarthritis
• KL grade of 2-3

You may not qualify if:

• Subjects less than 40 years of age
• Previous reconstructive knee surgery
• Participating in another clinical trial
• Unable to receive corticosteroid injections (i.e., allergies, adverse reactions, etc.)
• Unable to sign informed consent
• Pregnant or plan to become pregnant

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (9)

• Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies. EClinicalMedicine. 2020 Nov 26;29-30:100587. doi: 10.1016/j.eclinm.2020.100587. eCollection 2020 Dec.

  PMID: 34505846 RESULT

• Ayhan E, Kesmezacar H, Akgun I. Intraarticular injections (corticosteroid, hyaluronic acid, platelet rich plasma) for the knee osteoarthritis. World J Orthop. 2014 Jul 18;5(3):351-61. doi: 10.5312/wjo.v5.i3.351. eCollection 2014 Jul 18.

  PMID: 25035839 RESULT

• Bhatia D, Bejarano T, Novo M. Current interventions in the management of knee osteoarthritis. J Pharm Bioallied Sci. 2013 Jan;5(1):30-8. doi: 10.4103/0975-7406.106561.

  PMID: 23559821 RESULT

• Arroll B, Goodyear-Smith F. Corticosteroid injections for osteoarthritis of the knee: meta-analysis. BMJ. 2004 Apr 10;328(7444):869. doi: 10.1136/bmj.38039.573970.7C. Epub 2004 Mar 23.

  PMID: 15039276 RESULT

• Filardo G, Previtali D, Napoli F, Candrian C, Zaffagnini S, Grassi A. PRP Injections for the Treatment of Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials. Cartilage. 2021 Dec;13(1_suppl):364S-375S. doi: 10.1177/1947603520931170. Epub 2020 Jun 19.

  PMID: 32551947 RESULT

• Nguyen LT, Sharma AR, Chakraborty C, Saibaba B, Ahn ME, Lee SS. Review of Prospects of Biological Fluid Biomarkers in Osteoarthritis. Int J Mol Sci. 2017 Mar 12;18(3):601. doi: 10.3390/ijms18030601.

  PMID: 28287489 RESULT

• Lacko M, Harvanova D, Slovinska L, Matuska M, Balog M, Lackova A, Spakova T, Rosocha J. Effect of Intra-Articular Injection of Platelet-Rich Plasma on the Serum Levels of Osteoarthritic Biomarkers in Patients with Unilateral Knee Osteoarthritis. J Clin Med. 2021 Dec 11;10(24):5801. doi: 10.3390/jcm10245801.

  PMID: 34945097 RESULT

• Shamrock AG, Wolf BR, Ortiz SF, Duchman KR, Bollier MJ, Carender CN, Westermann RW. Preoperative Validation of the Patient-Reported Outcomes Measurement Information System in Patients With Articular Cartilage Defects of the Knee. Arthroscopy. 2020 Feb;36(2):516-520. doi: 10.1016/j.arthro.2019.08.043. Epub 2019 Dec 31.

  PMID: 31901394 RESULT

• Naal FD, Impellizzeri FM, Leunig M. Which is the best activity rating scale for patients undergoing total joint arthroplasty? Clin Orthop Relat Res. 2009 Apr;467(4):958-65. doi: 10.1007/s11999-008-0358-5. Epub 2008 Jun 28.

  PMID: 18587624 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Triamcinolone Acetonide; Suspensions; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Vicki Jones, MEd, CCRP

  University of Missouri-Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Syringes will be prepared and masked with opaque tape by the clinic nurses, thus providing blinding for subjects.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MOI INPATIENT MEDICAL DIRECTOR

Model Details: The patient is randomized into one of two treatment arms. Randomization is employed using a computer-generated random assignment sequence and results kept in envelopes. The patient is blinded to the injection received. Subjects receive the injection indicated by study arm at initial visit with a synovial fluid aspiration, urine, and blood collection. At the 1-month visit, subjects provide blood, urine, and synovial fluid aspiration. After the 1-month visit if the patient is experiencing pain and wants an injection, they are instructed to schedule a visit with the PI. If an injection is indicated, the patient is unblinded to which injection they previously received and may choose which to receive. If subject received steroid injection at initial visit, they must wait 3 months before receiving another steroid injection per standard of care guidelines. Subjects is required to complete VAS, KOOS-JR, and UCLA activity surveys at baseline, 2, 4, 8, 12, 24 , 26 and 52 weeks.

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: December 20, 2022
• Study Start: December 28, 2022
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)