PRP vs Corticosteroids for Knee Osteoarthritis

Overseen By Vicki Jones, MEd, CCRP

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Missouri-Columbia

Disqualifiers: Under 40, Previous knee surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 1 month

70 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug triamcinolone acetonide for treating knee osteoarthritis?

Triamcinolone acetonide has shown effectiveness in treating severe asthma and allergic eye conditions by reducing inflammation, which suggests it may help with inflammation in knee osteoarthritis as well. ^{1 2 3 4 5}

Is triamcinolone acetonide generally safe for use in humans?

Triamcinolone acetonide has been used in various treatments, such as for asthma and nasal conditions, with generally positive results and no serious side effects reported in most cases. However, some side effects like weight gain, menstrual disturbances, and increased blood pressure have been observed in a small percentage of patients. ^{1 2 3 6 7}

How does the treatment of PRP compare to corticosteroids for knee osteoarthritis?

Platelet-rich plasma (PRP) treatment for knee osteoarthritis is unique because it uses the patient's own blood to help control inflammation and improve joint function, potentially offering longer-lasting relief compared to corticosteroids, which provide immediate pain reduction but with limited long-term benefits. ^{8 9 10 11 12}

What is the purpose of this trial?

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.

Research Team

Vicki Jones, MEd, CCRP

Principal Investigator

University of Missouri-Columbia

Eligibility Criteria

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.

Inclusion Criteria

KL grade of 2-3

I have moderate or severe knee osteoarthritis but it's not in the end-stage.

I am over 40 and have a knee problem.

Exclusion Criteria

I have had knee surgery to rebuild it.

Participating in another clinical trial

Pregnant or plan to become pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a corticosteroid injection or a platelet-rich plasma injection at the initial visit. Synovial fluid is aspirated from the knee at the initial and one-month visits.

1 month

2 visits (in-person)

Follow-up

Participants are monitored for changes in pain scores and knee function over time, with surveys and biomarker analysis conducted at multiple intervals.

12 months

7 visits (in-person)

Treatment Details

Interventions

• Platelet-rich plasma Inj
• Triamcinolone Acetonide

Trial Overview 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.

Participant Groups

Group I: Platelet-rich Plasma Experimental Treatment 1 Intervention

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

Group II: Steroid Active Control 1 Intervention

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

Platelet-rich plasma Inj is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Platelet-rich plasma for:

• Orthopedic conditions including osteoarthritis, tendinitis, and ligament sprains

Approved in European Union as Platelet-rich plasma for:

• Orthopedic conditions including osteoarthritis, tendinitis, and ligament sprains

Approved in Canada as Platelet-rich plasma for:

• Orthopedic conditions including osteoarthritis, tendinitis, and ligament sprains

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Findings from Research

A new method using a 5.0-microm porous membrane filter can effectively isolate triamcinolone acetonide particles from its commercial suspension, significantly reducing the preparation time for intravitreal use.

This method successfully eliminates 99.7% of benzyl alcohol and 88.1% of high-viscosity carboxymethylcellulose, which may enhance the therapeutic efficacy of triamcinolone by minimizing additives that could interfere with its action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolating triamcinolone acetonide particles for intravitreal use with a porous membrane filter. Nishimura, A., Kobayashi, A., Segawa, Y., et al.[2019]

In a study of 31 eyes from 30 patients, subconjunctival injections of triamcinolone acetonide significantly improved visual acuity and reduced central macular thickness over 12 months, indicating its efficacy in treating uveitic macular edema.

The treatment was found to be safe, with no significant increase in intraocular pressure and only one cataract diagnosed, which occurred in an uninjected eye, suggesting minimal risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safety and efficacy of subconjunctival triamcinolone injections in the management of uveitic macular edema: retrospective study of thirty-one cases]. Bleriot, A., Couret, C., Le Meur, G., et al.[2014]

In a study of 145 patients with severe bronchial asthma, repeated intramuscular injections of triamcinolone acetonide (Kenalog) resulted in excellent or good outcomes in 88.3% of cases, indicating its high efficacy for patients who did not respond to other treatments.

While Kenalog was effective, 13.8% of patients experienced side effects such as weight gain and increased blood pressure, highlighting the need for careful monitoring during prolonged steroid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. Romański, B., Pawlik, K., Wilewska-Klubo, T.[2013]

In a study involving 57 patients with hypertrophic scars or keloids, high-pressure injections of triamcinolone acetonide resulted in significant improvement in 50% of cases, particularly in scar color, itching, and elevation.

The findings support the continued use of triamcinolone acetonide injections as a viable treatment option for certain patients with hypertrophic scars and keloids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cortisone jet injection as therapy of hypertrophic scars and keloids]. Zanon, E., Jungwirth, W., Anderl, H.[2022]

In a study of 35 patients with severe allergic keratoconjunctivitis, a supratarsal injection of 20 mg triamcinolone acetonide led to significant symptom improvement and partial resolution of clinical features within 2 weeks.

The treatment was generally safe, with only one case of ocular hypertension reported, and a low relapse rate of 10% for vernal keratoconjunctivitis and 6.7% for atopic keratoconjunctivitis after a follow-up of up to 11 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supratarsal injection of triamcinolone acetonide and childhood allergic keratoconjunctivitis. Zaouali, S., Kahloun, R., Attia, S., et al.[2021]

Triamcinolone acetonide (Kenalog) injections into the nasal turbinates have been successfully used in over 60,000 patients for treating allergic and vasomotor rhinitis, showing positive results without serious side effects.

The authors highlight the importance of preventing complications, such as intravascular injections that can affect the retinal circulation, by proposing specific methods to avoid this risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corticosteroid injections of the nasal turbinates: past experience and precautions. McCleve, D., Goldstein, J., Silver, S.[2019]

In a study of 943 eyes receiving intravitreal injections, the most common complication was subconjunctival hemorrhage, occurring in 36% of cases, indicating that while intravitreal injections are generally safe, they can lead to common ocular issues.

Triamcinolone injections were associated with a higher risk of cataract progression (23.4%) and elevated intraocular pressure (23.4% of cases), while serious complications like infectious endophthalmitis were rare, with only one confirmed case following a Kenalog injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Complications of intravitreal injections--own experience]. Jamrozy-Witkowska, A., Kowalska, K., Jankowska-Lech, I., et al.[2016]

Intra-articular platelet-rich plasma (PRP) injections significantly reduce symptoms of knee osteoarthritis (OA) compared to corticosteroid (CS) injections, showing the greatest improvement at 6 and 9 months post-treatment in a review of 8 studies involving 648 patients.

Triple PRP injections, spaced a week apart, are more effective than a single injection, leading to better pain management, reduced stiffness, and improved ability to participate in sports activities over a 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular platelet-rich plasma injections versus intra-articular corticosteroid injections for symptomatic management of knee osteoarthritis: systematic review and meta-analysis. McLarnon, M., Heron, N.[2021]

In a study of 100 patients with knee osteoarthritis, Triamcinolone Hexacetonide (TH) was found to be more effective than Saline Solution (SS) and Platelet-Rich Plasma (PRP) in improving pain and function over 52 weeks.

However, the PRP group exhibited the least radiographic progression, suggesting it may help slow down the worsening of knee osteoarthritis compared to TH and SS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular injection with platelet-rich plasma compared to triamcinolone hexacetonide or saline solution in knee osteoarthritis: A double blinded randomized controlled trial with one year follow-up. Nunes-Tamashiro, JC., Natour, J., Ramuth, FM., et al.[2022]

In a study of 50 patients with knee osteoarthritis, platelet-rich plasma (PRP) therapy showed a significant reduction in pain and improvement in function over 180 days compared to standard corticosteroid treatment (triamcinolone).

PRP therapy not only demonstrated effectiveness in alleviating pain and enhancing function but also had fewer side effects and provided longer-lasting benefits than corticosteroids, making it a promising alternative for treating knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effect between Infiltration of Platelet-rich Plasma and the Use of Corticosteroids in the Treatment of Knee Osteoarthritis: A Prospective and Randomized Clinical Trial. Freire, MRM., da Silva, PMC., Azevedo, AR., et al.[2020]

In a study of 40 patients with mild to moderate knee osteoarthritis, both platelet-rich plasma (PRP) and corticosteroid (CS) injections were found to be safe and effective for short-term pain relief and improved knee function, with no serious adverse effects reported.

However, PRP showed statistically significant improvements in pain and function compared to CS at the 15-week mark and continued to outperform CS at the 1-year follow-up, suggesting better long-term benefits of PRP for osteoarthritis treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular platelet-rich plasma vs corticosteroids in the treatment of moderate knee osteoarthritis: a single-center prospective randomized controlled study with a 1-year follow up. Elksniņš-Finogejevs, A., Vidal, L., Peredistijs, A.[2021]

In a study involving 62 participants with knee osteoarthritis, neither platelet-rich plasma (PRP) nor plasma showed significant improvement in pain or function compared to a saline placebo over 24 weeks.

The PRP group experienced a higher rate of mild adverse events, with 65% reporting increased pain, indicating that while PRP is a minimally invasive treatment, it may not be safer or more effective than placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of platelet-rich plasma and plasma for symptomatic treatment of knee osteoarthritis: a double-blinded placebo-controlled randomized clinical trial. Dório, M., Pereira, RMR., Luz, AGB., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Isolating triamcinolone acetonide particles for intravitreal use with a porous membrane filter. [2019]

2. France pubmed.ncbi.nlm.nih.gov

[Safety and efficacy of subconjunctival triamcinolone injections in the management of uveitic macular edema: retrospective study of thirty-one cases]. [2014]

3. Singapore pubmed.ncbi.nlm.nih.gov

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. [2013]

4. Germany pubmed.ncbi.nlm.nih.gov

[Cortisone jet injection as therapy of hypertrophic scars and keloids]. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Supratarsal injection of triamcinolone acetonide and childhood allergic keratoconjunctivitis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Corticosteroid injections of the nasal turbinates: past experience and precautions. [2019]

7. Poland pubmed.ncbi.nlm.nih.gov

[Complications of intravitreal injections--own experience]. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Intra-articular platelet-rich plasma injections versus intra-articular corticosteroid injections for symptomatic management of knee osteoarthritis: systematic review and meta-analysis. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Intra-articular injection with platelet-rich plasma compared to triamcinolone hexacetonide or saline solution in knee osteoarthritis: A double blinded randomized controlled trial with one year follow-up. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Comparative Effect between Infiltration of Platelet-rich Plasma and the Use of Corticosteroids in the Treatment of Knee Osteoarthritis: A Prospective and Randomized Clinical Trial. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Intra-articular platelet-rich plasma vs corticosteroids in the treatment of moderate knee osteoarthritis: a single-center prospective randomized controlled study with a 1-year follow up. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Efficacy of platelet-rich plasma and plasma for symptomatic treatment of knee osteoarthritis: a double-blinded placebo-controlled randomized clinical trial. [2022]