Platelet-Rich Plasma (PRP)PRPNCT06184048
Validation of a Low-cost Platelet-Rich Plasma (PRP)
A study testing Intra-Articular knee injection of LC-PRP in people with Platelet-Rich Plasma (PRP) and Knee Osteoarthritis (OA), run by University of Utah at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet-Rich Plasma (PRP), Knee Osteoarthritis (OA)
- What is being tested?
- Intra-Articular knee injection of LC-PRP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2023to 10 Oct 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopedic Center
Salt Lake City, Utah, 84108
About this study
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.
Read the detailed description
Study Purposes and Objectives:
The study will directly address two concerns - proper reporting of PRP composition and greatly decreasing cost. 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. The cost of this preparation technique is equivalent to the cost of a vial of corticosteroid and it is easy to replicate. In conjunction with Internal Departmental matching funds, this grant will cover the cost of resources to support the study, which will allow for future clinical and research endeavors in this realm.
The primary goal of this study is to validate this easy-to-replicate LC-PRP preparation technique to demonstrate that its composition is equivalent to standard, commercially-available PRP preparation kits. Validation must include data that match the minimum reporting standards for clinical studies evaluating PRP. Once validated, this will allow for a low-cost method to prepare PRP in countless clinical and research realms. Specifically, the investigators will analyze the components of both the whole blood (the subject's blood from which the PRP is extracted) and the PRP itself. Based on extensive pilot data, the platelet yield - the amount of platelets extracted from the patient's whole blood - is equivalent to those seen from expensive, commercially-available kits. Though this study will use neutrophil-poor PRP, this method can just as easily create neutrophil-rich PRP for other future clinical needs.
The investigators secondary goal is to prospectively evaluate pain and functional outcomes in a cohort of patients with knee OA. Based on the investigators pilot data, zero significant adverse events have been reported after treatment of over 1,000 patients with this technique in two separate geographical regions. The investigators have incomplete clinical outcome data, but it preliminarily demonstrates positive outcomes at 3 and 6 months in cohort. The investigators plan on using the results of this validation study to seek external funding for a randomized-controlled trial (RCT) comparing LC-PRP to corticosteroid injection for knee OA.
The investigator's tertiary goal is to conduct a cost-effectiveness analysis of LC-PRP compared to corticosteroid injection from a payor perspective using a computer simulation model. This simulation model, to be performed by Dr. Nelson, will be parameterized using a combination of data from the proposed study and from previously published literature. This model will also be a stepping stone for a cost-effectiveness analysis that will be conducted alongside the aforementioned future RCT.
- Being tested
- Intra-Articular knee injection of LC-PRP
- Keywords
- Platelet-Rich Plasma, PRP, Neutrophil-poor PRP
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-Articular knee injection of LC-PRPProcedure or surgery
Blood Collection 45mL, Processed Neutrophil-Poor PRP, 2 Injections at day 0 and 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Intra-Articular knee injection of LC-PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24-Months
Secondary outcomes (4)
Pain and functional outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 1, 3, 6, and 12 months after the second injection. Lastly, the investigator(s) will be evaluating adverse events for safety purposes.(functional and pain measure)
Measured: 24-Months
QOL outcomes
EQ-5D (EuroQual, quality of life measure) at 1, 3, 6, and 12 months after the second injection. Lastly, the investigator(s) will be evaluating adverse events for safety purposes.
Measured: 24-Months
Global impression of change
Global impression of change at 1, 3, 6, and 12 months after the second injection.
Measured: 24-Months
Patient Satisfaction (GPS)
Global patient satisfaction (GPS) at 1, 3, 6, and 12 months after the second injection.
Measured: 24-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start15 Sep 2023
- Primary completion15 Jun 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Platelet-Rich Plasma (PRP)Studies of the same condition, open and under way.
- More trials run by University of UtahThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Cushman, University of Utah
- Investigators
- Daniel Cushman, MD, Principal investigator, University of Utah Orthopedic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184048
- Sponsor's protocol ID
- 00159071
- Acronym
- PRP
- Status last verified
- Nov 2025
- First submitted
- 31 Oct 2022
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35124707Dai 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.
PubMed 28012636Chu 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.
PubMed 30300216Belk 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.
PubMed 32302218
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Low-cost Platelet-Rich Plasma (PRP)
- ClinicalTrials.gov ID
- NCT06184048
- Acronym / sponsor ID
- PRP / 00159071
- Keywords
- Platelet-Rich Plasma, PRP, Neutrophil-poor PRP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 28 Dec 2023 (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.
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.
Detailed description
Study Purposes and Objectives:
The study will directly address two concerns - proper reporting of PRP composition and greatly decreasing cost. 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. The cost of this preparation technique is equivalent to the cost of a vial of corticosteroid and it is easy to replicate. In conjunction with Internal Departmental matching funds, this grant will cover the cost of resources to support the study, which will allow for future clinical and research endeavors in this realm.
The primary goal of this study is to validate this easy-to-replicate LC-PRP preparation technique to demonstrate that its composition is equivalent to standard, commercially-available PRP preparation kits. Validation must include data that match the minimum reporting standards for clinical studies evaluating PRP. Once validated, this will allow for a low-cost method to prepare PRP in countless clinical and research realms. Specifically, the investigators will analyze the components of both the whole blood (the subject's blood from which the PRP is extracted) and the PRP itself. Based on extensive pilot data, the platelet yield - the amount of platelets extracted from the patient's whole blood - is equivalent to those seen from expensive, commercially-available kits. Though this study will use neutrophil-poor PRP, this method can just as easily create neutrophil-rich PRP for other future clinical needs.
The investigators secondary goal is to prospectively evaluate pain and functional outcomes in a cohort of patients with knee OA. Based on the investigators pilot data, zero significant adverse events have been reported after treatment of over 1,000 patients with this technique in two separate geographical regions. The investigators have incomplete clinical outcome data, but it preliminarily demonstrates positive outcomes at 3 and 6 months in cohort. The investigators plan on using the results of this validation study to seek external funding for a randomized-controlled trial (RCT) comparing LC-PRP to corticosteroid injection for knee OA.
The investigator's tertiary goal is to conduct a cost-effectiveness analysis of LC-PRP compared to corticosteroid injection from a payor perspective using a computer simulation model. This simulation model, to be performed by Dr. Nelson, will be parameterized using a combination of data from the proposed study and from previously published literature. This model will also be a stepping stone for a cost-effectiveness analysis that will be conducted alongside the aforementioned future RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Directly Address Two Concerns - Proper Reporting of PRP Composition and Greatly Decreasing Cost | Other | Procedure: Intra-Articular knee injection of LC-PRPAs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,
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 |
|---|---|---|
| Intra-Articular knee injection of LC-PRPBlood Collection 45mL, Processed Neutrophil-Poor PRP, 2 Injections at day 0 and 3 weeks. | Procedure or surgery | Directly Address Two Concerns - Proper Reporting of PRP Composition and Greatly Decreasing Cost |
Primary outcome
The primary goal of this study is to validate our easy-to replicate LC-PRP preparation technique
Time frame: 24-Months
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.
4 secondary outcomes
Pain and functional outcomes
Time frame: 24-Months
QOL outcomes
Time frame: 24-Months
Global impression of change
Time frame: 24-Months
Patient Satisfaction (GPS)
Time frame: 24-Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Background: PubMed 35124707Chu 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.
- Background: PubMed 28012636Dai 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.
- Background: PubMed 30300216Chu 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.
- Background: PubMed 32302218Belk 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.
- 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.
Daniel Cushman, MD principal investigator
University of Utah Orthopedic Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-Articular knee injection of LC-PRP in people with Platelet-Rich Plasma (PRP) and Knee Osteoarthritis (OA), run by University of Utah at 1 site in United States.
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 10 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: finished, as of the sponsor's last update on 17 Nov 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary goal of this study is to validate our easy-to replicate LC-PRP preparation technique (time frame: 24-Months). 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 NCT06184048, which also lists 4 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 17 Nov 2025.