Knee OsteoarthritisPhase 1/2NCT05657496

Biological Response to Platelet-rich Plasma and Corticosteroid Injections

A Phase 1/2 study testing Triamcinolone Acetonide 40 mg/ml Inj, Susp and Platelet-rich plasma Inj in people with Knee Osteoarthritis, run by University of Missouri-Columbia at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Triamcinolone Acetonide 40 mg/ml Inj, Susp and Platelet-rich plasma Inj
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: 28 Dec 2022to 18 Jun 2025
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Missouri
Columbia, Missouri, 65212

Other trials in United States

About this study

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.

Read the detailed description

Knee osteoarthritis (OA) is an extremely common cause of disability, with a global prevalence of 22.9% in adults aged 40 and over. OA is a whole-joint disease characterized by progressive degradation of articular cartilage, chronic inflammation of joint tissue, and subchondral bone remodeling, resulting in severe pain and decreased mobility in patients.

No cure currently exists for OA, and treatment is aimed at symptomatic management and prevention of disease progression. Currently, this consists of:

Initial conservative treatment for osteoarthritis across all levels of radiographic disease severity includes activity modification, oral analgesic or anti-inflammatory medications, non-supervised or supervised (e.g., physical therapy) exercise, and occasionally bracing.
Injection therapies have been used in the treatment of osteoarthritis for more than 60 years. Medical corticosteroids have served as a gold standard for symptom management as an intra-articular injection, but concerns have always existed around the potential for either the steroid medication (which suppresses both repair and inflammation processes) or the local anesthetic co-administered with the steroid to contribute to degradation of joint cartilage over time. Alternative substances have been developed to address the joint environment - with an intent to improve symptoms, while decreasing the potential for joint degeneration. These alternative medications include viscosupplements (hyaluronic acid analogues) and biological agents (platelet-rich plasma, or stem cell therapies).
Surgical interventions include arthroscopy for concurrent symptomatic meniscus tears or unstable cartilage that contribute to mechanical symptoms, osteotomy (realignment) surgery for active patients with single compartment arthritis, and arthroplasty (joint replacement) for patients with more limited activity goals, severe arthritis, and temporary-but not sustained---pain relief with the conservative treatments described in #1 and #2.

Intra-articular injection of a corticosteroid has been shown to be effective in providing short-term relief of knee OA symptoms, possibly due to anti-inflammatory and immunosuppressive effects. Repeated corticosteroid injections have thus become the standard of care for patients with mild to moderate knee OA.

Intra-articular injection of platelet-rich plasma (PRP) has emerged as a promising alternative to corticosteroid injection in knee OA patients. Studies have indicated that PRP is safe and may provide benefits such as pain relief, improved knee function, and enhanced quality of life. Moreover, PRP injection has been shown to provide longer-lasting symptomatic attenuation, with clinically significant improvement observed for as long as 12 months post-injection.

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 the investigators' 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
Being tested: Triamcinolone Acetonide 40 mg/ml Inj, Susp, Platelet-rich plasma Inj
Keywords: Knee Pain, Osteoarthritis, Corticosteroid, Platelet-rich Plasma (PRP)
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Triamcinolone Acetonide 40 mg/ml Inj, SuspDrug
Also called Corticosteroid injection
Prepared in clinic by physician or medical staff
Platelet-rich plasma InjBiological
Also called PRP
Produced from participant's whole blood venous draw of approximately 15 mL. Prepared by centrifuge in clinical office

Study groups in NCT05657496
Study group	Role	What they receive
Steroid	Active comparator	A 6mL injection at the initial visit of triamcinolone 40 mg/1 mL (Kenalog) with 5 mL of 1% lidocaine Receives: 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 Receives: Biological: Platelet-rich plasma Inj

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
RANTES is a proinflammatory chemokine involved in recruiting immune cells such as T cells, eosinophils, and basophils to sites of inflammation. It plays a significant role in chronic inflammatory conditions, autoimmune diseases, and allergic responses.
Measured: 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.
IL-1β is a key proinflammatory cytokine produced by activated macrophages and plays a central role in mediating the inflammatory response. It contributes to fever, leukocyte recruitment, and the progression of various inflammatory and autoimmune diseases.
Measured: 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.
IL-6 is a multifunctional proinflammatory cytokine involved in immune regulation, acute phase responses, and hematopoiesis. It plays a critical role in chronic inflammation and has been associated with autoimmune disorders, infection, and cancer.
Measured: 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.
IL-8 is a proinflammatory chemokine that primarily functions to attract and activate neutrophils at sites of infection or injury. It is involved in the pathogenesis of acute and chronic inflammatory conditions.
Measured: 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.
TNF-α is a potent proinflammatory cytokine produced mainly by macrophages that plays a central role in systemic inflammation. It is involved in the pathophysiology of autoimmune diseases, sepsis, and chronic inflammatory conditions.
Measured: 12 months
Difference in concentration of MIP-1a proinflammatory biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
MIP-1α is a proinflammatory chemokine that recruits and activates immune cells, particularly monocytes, macrophages, and T cells. It plays a role in acute and chronic inflammatory responses, as well as in the progression of certain infectious and autoimmune diseases.
Measured: 12 months
Difference in concentration of PGE2 proinflammatory biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
PGE2 is a lipid mediator involved in the regulation of inflammation, pain, and fever through its effects on vasodilation and immune cell activity. It is produced at sites of tissue damage and contributes to both acute and chronic inflammatory responses.
Measured: 12 months
Difference in concentration of IL-1RA anti-inflammatory biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
IL-1RA is an anti-inflammatory cytokine that inhibits the activity of IL-1α and IL-1β by competitively binding to the IL-1 receptor without eliciting a signal. It plays a protective role in controlling excessive inflammation and is used therapeutically in inflammatory diseases like rheumatoid arthritis.
Measured: 12 months
Difference in concentration of IL-4 anti-inflammatory biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
IL-4 is an anti-inflammatory cytokine that promotes the differentiation of naïve T cells into Th2 cells and inhibits the production of proinflammatory cytokines. It plays a key role in regulating immune responses, particularly in allergy and humoral immunity.
Measured: 12 months
Difference in concentration of IL-10 anti-inflammatory biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
IL-10 is a potent anti-inflammatory cytokine that suppresses the expression of proinflammatory cytokines, chemokines, and antigen presentation. It plays a crucial role in limiting immune responses and maintaining immune homeostasis during inflammation and infection.
Measured: 12 months
Difference in concentration of MMP pro-degradative biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
MMPs are a family of pro-degradative enzymes that break down extracellular matrix components during normal tissue remodeling and in pathological processes. They are upregulated in inflammatory and degenerative conditions, contributing to tissue destruction and disease progression.
Measured: 12 months
Difference in concentration of TIMP-1 anti-degradative biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
TIMP-1 is an anti-degradative protein that inhibits matrix metalloproteinases (MMPs), helping to preserve extracellular matrix integrity. It plays a protective role in tissue remodeling and counteracts excessive degradation in inflammatory and fibrotic conditions.
Measured: 12 months
Difference in concentration of TIMP-2 anti-degradative biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
TIMP-2 is an anti-degradative protein that specifically inhibits several MMPs, thereby regulating extracellular matrix turnover and preventing excessive tissue breakdown. It also plays a role in modulating cell growth, angiogenesis, and tissue repair processes.
Measured: 12 months
Difference in concentration of COMP from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
COMP is a non-collagenous extracellular matrix protein primarily found in cartilage, tendons, and ligaments. Elevated levels in blood or synovial fluid are associated with cartilage degradation and are used as a biomarker for osteoarthritis and other joint disorders.
Measured: 12 months
Difference in concentration of CTX-1 from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
CTX-1 is a bone resorption marker released during the degradation of type I collagen, the main component of bone matrix. It is commonly used to assess bone turnover and monitor conditions such as osteoporosis or the effects of anti-resorptive therapies.
Measured: 12 months
Difference in concentration of CTX-II from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
CTX-II is a biomarker of cartilage degradation, released during the breakdown of type II collagen, which is primarily found in articular cartilage. Elevated levels are associated with joint degeneration and are commonly used in the assessment of osteoarthritis and other cartilage-related disorders.
Measured: 12 months
Difference in concentration of PIICP from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
PIICP is a biomarker of cartilage synthesis, released during the formation of type II collagen, a key structural component of articular cartilage. Elevated levels indicate active cartilage formation and are used to monitor cartilage repair or regeneration in joint diseases.
Measured: 12 months
Difference in concentration of HA from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month, and possibly 3 and 6 months timeframes
Hyaluronic acid is a major component of synovial fluid and extracellular matrix, playing a crucial role in joint lubrication and cartilage health. Elevated levels in serum or synovial fluid can indicate joint inflammation or degeneration, such as in osteoarthritis or rheumatoid arthritis.
Measured: 12 months
Difference in concentration of biomarkers in the collected specimens after the first intraarticular knee injection of PRP from the second injection at 1 month.
This outcome measures the change in concentration of specific inflammatory, anti-inflammatory, degradative, and cartilage-related biomarkers in synovial fluid or blood between the first platelet-rich plasma (PRP) knee injection and the follow-up injection one month later. The goal is to assess the biological response to PRP therapy over time and identify potential markers of treatment efficacy.
Measured: 12 months
Correlating the change of specific biomarker concentrations with the change of patient-reported outcome scores
This outcome evaluates the relationship between changes in biomarker concentrations and changes in patient-reported outcome measures (PROMs) following PRP treatment. The aim is to determine whether biological responses to therapy are associated with clinical improvements in pain, function, or quality of life.
Measured: 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
Low of 0, high of 10. Higher score means more pain and worse outcome
Measured: 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
Low of 0, high of 10. Higher score means better knee function
Measured: 12 months
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
Multiple questions determining knee stiffness, daily functioning with knee involved activities, and knee pain.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Dec 202218 Jun 2025

First posted20 Dec 2022
Study start28 Dec 2022
Primary completion18 Jun 2025
Study completion18 Jun 2025

Why it stopped: Principal Investigator is Retiring.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Single blind
Who is masked: Participant
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05657496
Sponsor's protocol ID: 2092036
Status last verified: Jun 2025
First submitted: 3 Jul 2022
Last updated: 25 Jun 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34505846
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.
PubMed 25035839
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.
PubMed 23559821
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.
PubMed 15039276
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.
PubMed 32551947
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.
PubMed 28287489
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.
PubMed 34945097
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.
PubMed 31901394
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.
PubMed 18587624

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Osteoarthritis of the Knee
RecruitingObservational study
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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Biological Response to Platelet-rich Plasma and Corticosteroid Injections
ClinicalTrials.gov ID: NCT05657496
Acronym / sponsor ID: 2092036
Conditions: Knee Osteoarthritis
Keywords: Knee Pain, Osteoarthritis, Corticosteroid, Platelet-rich Plasma (PRP)
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Principal Investigator is Retiring.
Enrolment: 23 participants (actual)
Lead sponsor: University of Missouri-ColumbiaUniversity, hospital or other
Study start: 28 Dec 2022 (actual)
Primary completion: 18 Jun 2025 (actual)
Study completion: 18 Jun 2025 (actual)
First posted: 20 Dec 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

No cure currently exists for OA, and treatment is aimed at symptomatic management and prevention of disease progression. Currently, this consists of:

Initial conservative treatment for osteoarthritis across all levels of radiographic disease severity includes activity modification, oral analgesic or anti-inflammatory medications, non-supervised or supervised (e.g., physical therapy) exercise, and occasionally bracing.
Injection therapies have been used in the treatment of osteoarthritis for more than 60 years. Medical corticosteroids have served as a gold standard for symptom management as an intra-articular injection, but concerns have always existed around the potential for either the steroid medication (which suppresses both repair and inflammation processes) or the local anesthetic co-administered with the steroid to contribute to degradation of joint cartilage over time. Alternative substances have been developed to address the joint environment - with an intent to improve symptoms, while decreasing the potential for joint degeneration. These alternative medications include viscosupplements (hyaluronic acid analogues) and biological agents (platelet-rich plasma, or stem cell therapies).
Surgical interventions include arthroscopy for concurrent symptomatic meniscus tears or unstable cartilage that contribute to mechanical symptoms, osteotomy (realignment) surgery for active patients with single compartment arthritis, and arthroplasty (joint replacement) for patients with more limited activity goals, severe arthritis, and temporary-but not sustained---pain relief with the conservative treatments described in #1 and #2.

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 the investigators' 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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Steroid	Active comparator	Drug: Triamcinolone Acetonide 40 mg/ml Inj, SuspA 6mL injection at the initial visit of triamcinolone 40 mg/1 mL (Kenalog) with 5 mL of 1% lidocaine
Platelet-rich Plasma	Experimental	Biological: Platelet-rich plasma InjAn injection at the initial visit of approximately 4-6 mL of PRP

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Triamcinolone Acetonide 40 mg/ml Inj, SuspAlso: Corticosteroid injectionPrepared in clinic by physician or medical staff	Drug	Steroid
Platelet-rich plasma InjAlso: PRPProduced from participant's whole blood venous draw of approximately 15 mL. Prepared by centrifuge in clinical office	Biological	Platelet-rich Plasma

Primary outcome

Difference in concentration of MCP-1 proinflammatory biomarker from baseline in the serum after intraarticular knee injection of PRP at 1 month.
Time frame: 12 months
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.
Difference in concentration of MCP-1 proinflammatory biomarker from baseline in the urine after intraarticular knee injection of PRP at 1 month.
Time frame: 12 months
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.
Difference in concentration of MCP-1 proinflammatory biomarker from baseline in the synovial fluid after intraarticular knee injection of PRP at 1 month.
Time frame: 12 months
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.

23 secondary outcomes

Difference in concentration of RANTES proinflammatory biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Difference in concentration of MIP-1a proinflammatory biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
Time frame: 12 months
Difference in concentration of PGE2 proinflammatory biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
Time frame: 12 months
Difference in concentration of IL-1RA anti-inflammatory biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
Time frame: 12 months
Difference in concentration of IL-4 anti-inflammatory biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
Time frame: 12 months
Difference in concentration of IL-10 anti-inflammatory biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
Time frame: 12 months
Difference in concentration of MMP pro-degradative biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
Time frame: 12 months
Difference in concentration of TIMP-1 anti-degradative biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
Time frame: 12 months
Difference in concentration of TIMP-2 anti-degradative biomarker from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
Time frame: 12 months
Difference in concentration of COMP from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
Time frame: 12 months
Difference in concentration of CTX-1 from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
Time frame: 12 months
Difference in concentration of CTX-II from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
Time frame: 12 months
Difference in concentration of PIICP from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month.
Time frame: 12 months
Difference in concentration of HA from baseline in the collected specimens after intraarticular knee injection of PRP at 1 month, and possibly 3 and 6 months timeframes
Time frame: 12 months
Difference in concentration of biomarkers in the collected specimens after the first intraarticular knee injection of PRP from the second injection at 1 month.
Time frame: 12 months
Correlating the change of specific biomarker concentrations with the change of patient-reported outcome scores
Time frame: 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
Time frame: 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
Time frame: 12 months
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
Time frame: 12 months

Results and safety

The study was stopped early (reason given: Principal Investigator is Retiring.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
Results publication: PubMed 34505846Cui 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.
Results publication: PubMed 25035839Ayhan 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.
Results publication: PubMed 23559821Bhatia 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.
Results publication: PubMed 15039276Arroll 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.
Results publication: PubMed 32551947Filardo 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.
Results publication: PubMed 28287489Nguyen 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.
Results publication: PubMed 34945097Lacko 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.
Results publication: PubMed 31901394Shamrock 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.
Results publication: PubMed 18587624Naal 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vicki Jones, MEd, CCRP study director

University of Missouri-Columbia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Principal Investigator is Retiring.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in concentration of MCP-1 proinflammatory biomarker from baseline in the serum after intraarticular knee injection of PRP at 1 month. (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05657496, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.