Platelet Rich Plasma in Knee Osteoarthritis

NCT05080075 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 301106-UT
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators will be performing intra-articular platelet rich plasma (PRP) injections for patients experiencing pain related to osteoarthritis of the knee. The investigators will be following clinical outcomes, and how they relate to concentrations of the PRP samples as well as following opioid and emergency room utilization pre and post-injection.

Conditions

Knee Osteoarthritis

Keywords

Platelet rich plasma; PRP; Knee osteoarthritis; Platelet concentration

Outcome Measures

Primary Outcomes (12)

• Initial Pain outcomes

  The investigators will have patients rate pain levels using the visual analog scale (VAS), which measures pain on a 1-10 point scale. A score of 10 indicates the highest level of pain. These will be performed on the day of the platelet rich plasma injection, shortly before the procedure is performed.

  Start of the study, pre-injection

• Pain outcomes, 3 months

  The investigators will have patients rate pain levels using the visual analog scale (VAS), which measures pain on a 1-10 point scale. A score of 10 indicates the highest level of pain.

  3 months

• Pain outcomes, 6 months

  The investigators will have patients rate pain levels using the visual analog scale (VAS), which measures pain on a 1-10 point scale. A score of 10 indicates the highest level of pain.

  6 months

• Pain outcomes, 1 year

  The investigators will have patients rate pain levels using the visual analog scale (VAS), which measures pain on a 1-10 point scale. A score of 10 indicates the highest level of pain.

  1 year

• Functional status outcomes using the Western Ontario and McMaster University Arthritis Index (WOMAC), initial

  Research participants will fill out a the WOMAC questionnaire. The WOMAC is a self administered questionnaire consisting of 24 items divided into subscales including pain (0-20), stiffness (0-8) and physical function (0-68). Higher scores indicate worse pain, stiffness and functional limitations.

  Start of the study, pre-injection

• Functional status outcomes using the Western Ontario and McMaster University Arthritis Index (WOMAC), 3 months

  Research participants will fill out a the WOMAC questionnaire. The WOMAC is a self administered questionnaire consisting of 24 items divided into subscales including pain (0-20), stiffness (0-8) and physical function (0-68). Higher scores indicate worse pain, stiffness and functional limitations.

  3 months

• Functional status outcomes using the Western Ontario and McMaster University Arthritis Index (WOMAC), 6 months

  Research participants will fill out a the WOMAC questionnaire. The WOMAC is a self administered questionnaire consisting of 24 items divided into subscales including pain (0-20), stiffness (0-8) and physical function (0-68). Higher scores indicate worse pain, stiffness and functional limitations.

  6 months

• Functional status outcome using the Timed up and go (TUG) test, initial

  The investigators will have participants perform a TUG test. The TUG test is an investigator administered test measuring the time it takes research participants to stand from a chair, walk three meters, turn around, walk back and sit down. It is timed in seconds, and a longer time to perform this task indicates a lower level of function.

  Start of the study, pre-injection

• Functional status outcome using the Timed up and go (TUG) test, 3 months

  The investigators will have participants perform a TUG test. The TUG test is an investigator administered test measuring the time it takes research participants to stand from a chair, walk three meters, turn around, walk back and sit down. It is timed in seconds, and a longer time to perform this task indicates a lower level of function.

  3 months

• Functional status outcome using the Timed up and go (TUG) test, 6 months

  The investigators will have participants perform a TUG test. The TUG test is an investigator administered test measuring the time it takes research participants to stand from a chair, walk three meters, turn around, walk back and sit down. It is timed in seconds, and a longer time to perform this task indicates a lower level of function.

  6 months

• Functional status outcome using the Timed up and go (TUG) test, 1 year

  The investigators will have participants perform a TUG test. The TUG test is an investigator administered test measuring the time it takes research participants to stand from a chair, walk three meters, turn around, walk back and sit down. It is timed in seconds, and a longer time to perform this task indicates a lower level of function.

  1 year

• Correlation of outcomes with whole blood and platelet rich plasma (PRP) concentrations

  The investigators will be determining if there is a correlation between the pain (VAS) and all functional outcomes (WOMAC and TUG) listed above, and whole blood and platelet rich plasma (PRP) concentrations. For PRP concentrations the investigators will be assessing platelet (and platelet activation), monocyte, neutrophil levels using flow cytometry. For whole blood concentrations the investigators will be using the hospitals lab system. These concentrations will be measured once on the day of the injection for each participant.

  Through study completion, 1 year

Secondary Outcomes (9)

• Opioid utilization, initial

  Start of the Study, pre-injection

• Opioid utilization, 3 months

  3 months

• Opioid utilization, 6 months

  6 months

• Opioid utilization, 1 year

  1 year

• Emergency room utilization, initial

  Start of the study, pre-injection

Study Arms (1)

Participants receiving a platelet rich plasma injection

EXPERIMENTAL

All patients in the study will be receiving a platelet rich plasma injection, and we will be following their clinical outcomes

Biological: Platelet Rich Plasma Injection

Interventions

Platelet Rich Plasma Injection BIOLOGICAL

Research participants own blood will be used to prepare the platelet rich plasma injectate, which will be injected into the affected knee using ultrasound guidance.

Also known as: PRP Injection

Participants receiving a platelet rich plasma injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Knee pain or swelling that has been present for greater than 3 months
• Knee pain greater than or equal to 3 out of 10 on the visual analog scale
• Previous radiological evidence (X-ray) of osteoarthritis
• Age 18 or older

You may not qualify if:

• Unable to provide consent for enrollment in the study
• Unable to avoid NSAIDs during the study (must stop 7 days before injection)
• Age less than 18
• Confirmed rheumatologic disease affecting the knee
• Significant trauma to the knee within 2 months that resulted in pain and/or swelling
• Active malignancy
• Pregnancy
• Local injections to the knee within the last 3 months
• Previous knee surgery
• Other causes of knee pain (nerve pain, referred pain, infection of the knee joint, etc)
• History of platelet disorder
• History of thrombocytopenia
• History of severe anemia
• Severe cardiovascular disease
• Active infection

Sponsors & Collaborators

• University of Toledo Health Science Campus: lead

Study Sites (1)

University of Toledo, Health Science Campus

Toledo, Ohio, 43606, United States

Location

Related Publications (20)

• Belk JW, Kraeutler MJ, Houck DA, Goodrich JA, Dragoo JL, McCarty EC. Platelet-Rich Plasma Versus Hyaluronic Acid for Knee Osteoarthritis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Am J Sports Med. 2021 Jan;49(1):249-260. doi: 10.1177/0363546520909397. Epub 2020 Apr 17.

  PMID: 32302218 BACKGROUND

• Cole BJ, Karas V, Hussey K, Pilz K, Fortier LA. Hyaluronic Acid Versus Platelet-Rich Plasma: A Prospective, Double-Blind Randomized Controlled Trial Comparing Clinical Outcomes and Effects on Intra-articular Biology for the Treatment of Knee Osteoarthritis. Am J Sports Med. 2017 Feb;45(2):339-346. doi: 10.1177/0363546516665809. Epub 2016 Oct 21.

  PMID: 28146403 BACKGROUND

• Dernek B, Kesiktas FN, Duymus TM, Aydin T, Isiksacan N, Diracoglu D, Aksoy C. Effect of platelet concentration on clinical improvement in treatment of early stage-knee osteoarthritis with platelet-rich plasma concentrations. J Phys Ther Sci. 2017 May;29(5):896-901. doi: 10.1589/jpts.29.896. Epub 2017 May 16.

  PMID: 28603367 BACKGROUND

• Di Martino A, Di Matteo B, Papio T, Tentoni F, Selleri F, Cenacchi A, Kon E, Filardo G. Platelet-Rich Plasma Versus Hyaluronic Acid Injections for the Treatment of Knee Osteoarthritis: Results at 5 Years of a Double-Blind, Randomized Controlled Trial. Am J Sports Med. 2019 Feb;47(2):347-354. doi: 10.1177/0363546518814532. Epub 2018 Dec 13.

  PMID: 30545242 BACKGROUND

• Filardo G, Di Matteo B, Di Martino A, Merli ML, Cenacchi A, Fornasari P, Marcacci M, Kon E. Platelet-Rich Plasma Intra-articular Knee Injections Show No Superiority Versus Viscosupplementation: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1575-82. doi: 10.1177/0363546515582027. Epub 2015 May 7.

  PMID: 25952818 BACKGROUND

• Filardo G, Kon E, Pereira Ruiz MT, Vaccaro F, Guitaldi R, Di Martino A, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma intra-articular injections for cartilage degeneration and osteoarthritis: single- versus double-spinning approach. Knee Surg Sports Traumatol Arthrosc. 2012 Oct;20(10):2082-91. doi: 10.1007/s00167-011-1837-x. Epub 2011 Dec 28.

  PMID: 22203046 BACKGROUND

• Ghai B, Gupta V, Jain A, Goel N, Chouhan D, Batra YK. [Effectiveness of platelet rich plasma in pain management of osteoarthritis knee: double blind, randomized comparative study]. Braz J Anesthesiol. 2019 Sep-Oct;69(5):439-447. doi: 10.1016/j.bjan.2019.06.003. Epub 2019 Oct 28.

  PMID: 31672420 BACKGROUND

• Gormeli G, Gormeli CA, Ataoglu B, Colak C, Aslanturk O, Ertem K. Multiple PRP injections are more effective than single injections and hyaluronic acid in knees with early osteoarthritis: a randomized, double-blind, placebo-controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Mar;25(3):958-965. doi: 10.1007/s00167-015-3705-6. Epub 2015 Aug 2.

  PMID: 26233594 BACKGROUND

• Kon E, Buda R, Filardo G, Di Martino A, Timoncini A, Cenacchi A, Fornasari PM, Giannini S, Marcacci M. Platelet-rich plasma: intra-articular knee injections produced favorable results on degenerative cartilage lesions. Knee Surg Sports Traumatol Arthrosc. 2010 Apr;18(4):472-9. doi: 10.1007/s00167-009-0940-8. Epub 2009 Oct 17.

  PMID: 19838676 BACKGROUND

• Lana JF, Macedo A, Ingrao ILG, Huber SC, Santos GS, Santana MHA. Leukocyte-rich PRP for knee osteoarthritis: Current concepts. J Clin Orthop Trauma. 2019 Oct;10(Suppl 1):S179-S182. doi: 10.1016/j.jcot.2019.01.011. Epub 2019 Jan 14.

  PMID: 31700210 BACKGROUND

• Lin KY, Yang CC, Hsu CJ, Yeh ML, Renn JH. Intra-articular Injection of Platelet-Rich Plasma Is Superior to Hyaluronic Acid or Saline Solution in the Treatment of Mild to Moderate Knee Osteoarthritis: A Randomized, Double-Blind, Triple-Parallel, Placebo-Controlled Clinical Trial. Arthroscopy. 2019 Jan;35(1):106-117. doi: 10.1016/j.arthro.2018.06.035.

  PMID: 30611335 BACKGROUND

• O'Connell B, Wragg NM, Wilson SL. The use of PRP injections in the management of knee osteoarthritis. Cell Tissue Res. 2019 May;376(2):143-152. doi: 10.1007/s00441-019-02996-x. Epub 2019 Feb 13.

  PMID: 30758709 BACKGROUND

• Park YB, Kim JH, Ha CW, Lee DH. Clinical Efficacy of Platelet-Rich Plasma Injection and Its Association With Growth Factors in the Treatment of Mild to Moderate Knee Osteoarthritis: A Randomized Double-Blind Controlled Clinical Trial As Compared With Hyaluronic Acid. Am J Sports Med. 2021 Feb;49(2):487-496. doi: 10.1177/0363546520986867.

  PMID: 33523756 BACKGROUND

• Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013 Feb;41(2):356-64. doi: 10.1177/0363546512471299. Epub 2013 Jan 8.

  PMID: 23299850 BACKGROUND

• Raeissadat SA, Rayegani SM, Babaee M, Ghorbani E. The effect of platelet-rich plasma on pain, function, and quality of life of patients with knee osteoarthritis. Pain Res Treat. 2013;2013:165967. doi: 10.1155/2013/165967. Epub 2013 Dec 9.

  PMID: 24386565 BACKGROUND

• Rahimzadeh P, Imani F, Faiz SHR, Entezary SR, Zamanabadi MN, Alebouyeh MR. The effects of injecting intra-articular platelet-rich plasma or prolotherapy on pain score and function in knee osteoarthritis. Clin Interv Aging. 2018 Jan 4;13:73-79. doi: 10.2147/CIA.S147757. eCollection 2018.

  PMID: 29379278 BACKGROUND

• Riboh JC, Saltzman BM, Yanke AB, Fortier L, Cole BJ. Effect of Leukocyte Concentration on the Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis. Am J Sports Med. 2016 Mar;44(3):792-800. doi: 10.1177/0363546515580787. Epub 2015 Apr 29.

  PMID: 25925602 BACKGROUND

• Sanchez M, Fiz N, Azofra J, Usabiaga J, Aduriz Recalde E, Garcia Gutierrez A, Albillos J, Garate R, Aguirre JJ, Padilla S, Orive G, Anitua E. A randomized clinical trial evaluating plasma rich in growth factors (PRGF-Endoret) versus hyaluronic acid in the short-term treatment of symptomatic knee osteoarthritis. Arthroscopy. 2012 Aug;28(8):1070-8. doi: 10.1016/j.arthro.2012.05.011.

  PMID: 22840987 BACKGROUND

• Simental-Mendia M, Vilchez-Cavazos JF, Pena-Martinez VM, Said-Fernandez S, Lara-Arias J, Martinez-Rodriguez HG. Leukocyte-poor platelet-rich plasma is more effective than the conventional therapy with acetaminophen for the treatment of early knee osteoarthritis. Arch Orthop Trauma Surg. 2016 Dec;136(12):1723-1732. doi: 10.1007/s00402-016-2545-2. Epub 2016 Aug 9.

  PMID: 27506585 BACKGROUND

• Taniguchi Y, Yoshioka T, Kanamori A, Aoto K, Sugaya H, Yamazaki M. Intra-articular platelet-rich plasma (PRP) injections for treating knee pain associated with osteoarthritis of the knee in the Japanese population: a phase I and IIa clinical trial. Nagoya J Med Sci. 2018 Feb;80(1):39-51. doi: 10.18999/nagjms.80.1.39.

  PMID: 29581613 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Christian Wuescher, MD

  University of Toledo

  PRINCIPAL INVESTIGATOR

• Ashley Schneider, MD

  University of Toledo

  STUDY DIRECTOR

• Leah Wuescher, PhD

  University of Toledo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: All patients will get the treatment, and all those providing care and all involved in the study, including the research participants are aware of this
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study involves a single group, all of whom will be receiving the same treatment (platelet rich plasma injection into the knee)

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: October 15, 2021
• Study Start: December 2, 2021
• Primary Completion: November 6, 2023
• Study Completion: November 6, 2023
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)