Validation of a Low-cost Platelet-Rich Plasma (PRP)

NCT06184048 | Completed DMC

• 1 other identifier: 00159071
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis is an extremely common and debilitating condition, more common in women, with an estimated global prevalence of 16%, and as high as 50% by the age of 80. Current management of knee osteoarthritis (OA) revolves around conservative treatments- biomechanical interventions, intra-articular injections, exercise, self-management and education, oral or topical medications, strength training, and weight management - or surgical management. For injection therapies, corticosteroids remain the standard of care; approximately 84% of sports medicine physicians perform these knee injections at least monthly, reporting a median range of 11-20 injections per month. Multiple detrimental effects of corticosteroid injections are well-known, including alterations of the hypothalamic-pituitary-adrenal axis, blood glucose levels, bone turnover, inflammatory response, blood pressure, and psychologic well-being. Thus, alternative therapies are of the utmost importance. Platelet-Rich Plasma (PRP) is an injectable preparation of a patient's blood that can be used for numerous conditions and has received significant attention over the past several years for its potential application for the treatment of pain and functional impairment due to knee OA. Systematic reviews of randomized-controlled trials have demonstrated equivalent-to-superior treatment outcomes associated with the use of intra-articular PRP compared to placebo, hyaluronic acid, and corticosteroid. Furthermore, use of intra-articular PRP is associated with a very low rate of adverse events and is likely safer than injectable corticosteroids. Concerns that have limited a wider use of PRP include two main concerns - an uncertainty regarding the current evidence base due to study-related bias, heterogeneity, and lack of reporting standards; and second, more importantly, the main issue remains high cost.

Conditions

Platelet-Rich Plasma (PRP); Knee Osteoarthritis (OA)

Keywords

Platelet-Rich Plasma; PRP; Neutrophil-poor PRP

Outcome Measures

Primary Outcomes (1)

• The primary goal of this study is to validate our easy-to replicate LC-PRP preparation technique

  The primary goal of this study is to validate the investigator(s) easy-to-replicate LC-PRP preparation technique to demonstrate that its composition is equivalent to standard, commercially-available PRP preparation kits. The investigators will specifically compare the quantity of platelets derived from their system compared to previously published platelet counts for commercially available PRP preparation kits.

  24-Months

Secondary Outcomes (4)

• Pain and functional outcomes

  24-Months

• QOL outcomes

  24-Months

• Global impression of change

  24-Months

• Patient Satisfaction (GPS)

  24-Months

Other Outcomes (3)

• Cost-effectiveness

  24-Months

• Healthcare utilization

  24-Months

• Direct medical costs

  24-Months

Study Arms (1)

Directly Address Two Concerns - Proper Reporting of PRP Composition and Greatly Decreasing Cost

OTHER

As socioeconomic inequity directly relates to disability related to knee Osteoarthritis (OA), limiting the cost of treatment is of the utmost importance to ensure appropriate delivery of care to all patients. As PRP is currently not covered by the vast majority of public and private payors, patients are required to pay for the injections out of pocket, with an average cost of $714 per injection (as high as $2,092). Furthermore, research studies relating to PRP are often expensive due to the cost of the traditional method of extracting PRP, generally with commercial kits, and thus limited in scope. The investigators have developed and implemented a low-cost PRP (LC-PRP) preparation technique and have safely performed the injections on hundreds of patients with knee OA.

Procedure: Intra-Articular knee injection of LC-PRP

Interventions

Intra-Articular knee injection of LC-PRP PROCEDURE

Blood Collection 45mL, Processed Neutrophil-Poor PRP, 2 Injections at day 0 and 3 weeks.

Directly Address Two Concerns - Proper Reporting of PRP Composition and Greatly Decreasing Cost

Eligibility Criteria

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

You may qualify if:

• Patients of any adult age with symptomatic Kellgren-Lawrence (K-L) score 1-3 knee OA, based on radiographs within the last six months.
• Patients must have failed at least six weeks of conventional conservative treatments (such as medication or physical therapy).
• Patients with bilateral knee OA will only be eligible if both knees fit the criteria; each knee will count separately.

You may not qualify if:

• Recent (last two years) knee surgery,
• Prior orthobiologic injection(s) into the knee,
• Known major axial deviation (over 30 degrees)
• Known thrombocytopenia (platelets under 50,000), thrombocythemia (platelets over 1,000,000), known platelet disorder (ITP, TTP, or Lowe syndrome)
• Active systemic infection requiring antibiotics, or local infection at the site of injection,
• Non-ambulatory patients,
• Patients seeking care with active litigation pending
• Body mass index (BMI) over 40
• Injection into the affected joint within the last six months
• Oral steroids consumed within the last three months.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopedic Center

Salt Lake City, Utah, 84108, United States

Location

Related Publications (4)

• Chu J, Duan W, Yu Z, Tao T, Xu J, Ma Q, Zhao L, Guo JJ. Intra-articular injections of platelet-rich plasma decrease pain and improve functional outcomes than sham saline in patients with knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2022 Dec;30(12):4063-4071. doi: 10.1007/s00167-022-06887-7. Epub 2022 Feb 6.

  PMID: 35124707 BACKGROUND

• Dai WL, Zhou AG, Zhang H, Zhang J. Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2017 Mar;33(3):659-670.e1. doi: 10.1016/j.arthro.2016.09.024. Epub 2016 Dec 22.

  PMID: 28012636 BACKGROUND

• Chu CR, Rodeo S, Bhutani N, Goodrich LR, Huard J, Irrgang J, LaPrade RF, Lattermann C, Lu Y, Mandelbaum B, Mao J, McIntyre L, Mishra A, Muschler GF, Piuzzi NS, Potter H, Spindler K, Tokish JM, Tuan R, Zaslav K, Maloney W. Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference. J Am Acad Orthop Surg. 2019 Jan 15;27(2):e50-e63. doi: 10.5435/JAAOS-D-18-00305.

  PMID: 30300216 BACKGROUND

• 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

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel Cushman, MD

  University of Utah Orthopedic Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Recruitment will take place at the University of Utah Orthopedic Center by physician and study study staff members EMR chart review prior to patient visits. The investigator plans to recruit a total of 30 participants to this project over a 24 month period of time.

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: December 28, 2023
• Study Start: September 15, 2023
• Primary Completion: June 15, 2024
• Study Completion: October 10, 2024
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)