HemarthrosisNCT06543368
Low-Cost Platelet-Rich Plasma for Hemarthropathy
A study testing Intra articular PRP Injection in people with Hemarthrosis and Hemophilia, run by University of Utah at 1 site in United States.
Trial summary
Orthopedic complications can be injuries or diseases that affect the bones, muscles, and joints. Hemarthropathy is due to bleeding disorders, most commonly hemophilia, and can result in severe issues related to chronic amounts of blood in the body's joints. This causes swelling, pain, and loss of joint function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemarthrosis, Hemophilia
- What is being tested?
- Intra articular PRP Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2024to 5 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 hemarthropathy of the ankle, knee, or elbow, based on radiographs within the last 24 months.
- Patients must have failed at least six weeks of conventional conservative treatments (such as medication or physical therapy).
Who cannot join
- Exclusion criteria will include recent (last two years) surgery to the affected joint, prior joint replacement.
- Prior orthobiologic injection into the affected joint.
- Thrombocytopenia
- Inability to receive factor prior to PRP injection.
- Active systemic or local infection at the site of injection,
- Non-ambulatory patients
Show all 9Show fewer
- Body mass index (BMI) over 50
- Recent (six month) or current corticosteroid injection/intake.
- Patients with hemarthropathy in multiple joints will be eligible for up to 2 joints if multiple fit the criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-Cost Platelet-Rich Plasma Injection for the Management of Hemarthropathy
Orthopedic complications can be injuries or diseases that affect the bones, muscles, and joints. Hemarthropathy is due to bleeding disorders, most commonly hemophilia, and can result in severe issues related to chronic amounts of blood in the body's joints. This causes swelling, pain, and loss of joint function. A serious barrier to treating many patients with bleeding disorders creates higher health risks and costs. Platelet-rich plasma (PRP) injection is a method that can reduce the cost of care while still offering a similar standard of care for patients.
This study intends to show that low-cost PRP can be done safely in patients with bleeding disorders, without the need for expensive equipment, while monitoring patient treatment results. Study participants will receive injections for joint conditions. Being in the study requires attending 1 to 2 in-person visits at the study clinic. Participants will also complete surveys using email, text messages, in person, and/or on the phone. Participation lasts about 6 months.
Read the detailed description
This study will be performed as a prospective, single arm study. Consecutive patients eligible for a standard-of-care injection will be enrolled from the Utah Center for Bleeding and Clotting Disorders. The University of Utah non-operative sports medicine team currently performs hundreds of injections monthly, and the PI works closely with the orthopedic complaints of patients with bleeding disorders. From a research standpoint, the investigators have successfully performed numerous randomized controlled prospective trials on a variety of musculoskeletal conditions in the past and have already validated this method on a large cohort of patients with knee osteoarthritis (OA).
Potential subjects will then be approached by a member of the research team to discuss the consideration of taking part in the study if they meet the inclusion criteria of this study project. Using all forms of good clinical practice, a member of the study team will review with the participant the Informed Consent Form, allow participant to read the informed consent (ICF) and ask questions prior to signing the ICF. Potential subjects may also be asked by other physicians or staff members familiar with the study.
Low Cost-Platelet Rich Plasma (LC-PRP) preparation method: See Documents for full details. This method follows the same procedures as the standard-of-care, FDA-cleared method used by numerous commercial machines; thus it does not require additional FDA clearance or approval. To summarize the full method in the appendix, 45mL of blood is drawn from the subject in a standard-of-care manner into 3 x 20mL syringes, each containing 2mL of sodium citrate (anticoagulant). Each syringe is prepared and capped, then placed into a centrifuge. The resulting separated blood is then drawn off into a single new sterile syringe, which can be used for the injection. Blood and PRP analysis: The investigators will perform a full analysis (a complete blood count (CBC) with differential) on subjects' whole blood and their prepared LC-PRP. Importantly, the investigators will include all data required in the PRP minimum reporting standards, including "platelet, differential leukocyte, and red cell analysis of all samples." Also note that although the investigators are collecting these values for the purposes of the study, CBC values are not needed in the community.
Injections: A total of 20 joints (estimated 10-15 patients) will receive injections, performed at day 0 and 3 weeks, for a total of two injections - two injections have demonstrated superior outcomes to one, and will increase our number of injections to improve the proof of feasibility. All subjects will receive ultrasound-guided intra-articular joint injections by an experienced sports medicine provider after local anesthesia with 1% lidocaine to the extra-articular structures, namely the skin and joint capsule, to increase comfort. Note: though the investigators are using ultrasound guidance to ensure that they are guaranteeing accurate injectate placement for this study, this is not necessarily required in the community setting. These will be performed after the patient's typical factor infusions, if applicable.
Questionnaire: The investigators will collect demographic information along with baseline and subsequent functional patient reported outcomes, namely the WOMAC (knee), FAOS (ankle), and the QuickDASH (elbow). REDCap will be used to administer surveys and store data. The investigators will additionally ask about adverse events, pain, global satisfaction, global injection satisfaction, and medications.
Data collection time points and follow-up: Follow-up data (see timeline below) will be administered electronically. Subjects will be queried by email, text message, in person, and/or by telephone regarding treatment outcomes at 0, 1, 3, and 6 months after the second injection. Three months will be the primary endpoint, and six months will be an exploratory, unfunded endpoint.
- LC-PRP Outcomes: As this is a feasibility study, it is likely that this study will be underpowered for clinical outcomes. However, the investigators will still monitor pain and the above outcome measures and identify potential time-related improvements.
- Economic Evaluation: The investigators will track staff-, time-, equipment-, and supply-related costs to accurately identify costs associated with each injection. This will ensure that costs are accurately recorded.
- Conditions
- Hemarthrosis, Hemophilia
- Being tested
- Intra articular PRP Injection
- Keywords
- Hemophilia, Hemarthrosis, PRP, Platelet Rich Plasma
- Medical subject headings
- Hemarthrosis, Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra articular PRP InjectionBiological
A total of 20 joints (estimated 10-15 patients) will receive injections, performed at day 0 and 3 weeks, for a total of two injections - two injections have demonstrated superior outcomes to one, and will increase our number of injections to improve the proof of feasibility. All subjects will receive ultrasound-guided intra-articular joint injections by an experienced sports medicine provider after local anesthesia with 1% lidocaine to the extra-articular structures, namely the skin and joint capsule, to increase comfort.
| Study group | Role | What they receive |
|---|---|---|
| PRP Injection | Experimental | 45mL of blood is drawn from the subject in a standard-of-care manner into 3 x 20mL syringes, each containing 2mL of sodium citrate (anticoagulant). Each syringe is prepared and capped, then placed into a centrifuge. The resulting separated blood is then drawn off into a single new sterile syringe, which can be used for the injection. Blood and PRP analysis: We will perform a full analysis (a complete blood count [CBC] with differential) on subjects' whole blood and their prepared LC-PRP. Importantly, we will include all data required in the PRP minimum reporting standards, including "platelet, differential leukocyte, and red cell analysis of all samples." Receives: Biological: Intra articular PRP Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Satisfaction (Numeric Rating System)
Global patient satisfaction was assessed prospectively at 6 months following the intervention using a numeric rating scale ranging from 0 to 100.
Participants were asked to rate their overall satisfaction with the treatment outcome, where 0 represented "not satisfied" and 100 represented "completely satisfied."
The score reflects the participant's overall perception of their injection, including symptom improvement and overall experience.
Measured: 6-months
Secondary outcomes (3)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description:
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a validated measure designed to assess pain, stiffness, and physical function in individuals with hip or knee osteoarthritis.
Structure:
The WOMAC consists of 24 items divided into three subscales:
Pain (5 items): pain during walking, using stairs, lying/sitting, standing, and at night.
Stiffness (2 items): stiffness after first waking and later in the day. Physical Function (17 items): difficulty with daily activities such as rising from sitting, bending, walking, getting in/out of a car, shopping, and stair use.
Each item is rated using a 5-point Likert scale:
0 (none) - 4 (extreme)
Scoring:
Subscale scores are summed - Pain: 0-20 Stiffness: 0-8 Physical Function: 0-68 The total score is the sum of all items (range 0-96), with higher scores indicating worse symptoms.
Measured: 6-months
Quick Disabilities of Arm Shoulder and Hand (QuickDASH)
The Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) is a validated outcome measure designed to assess physical function and symptoms in individuals with upper-extremity musculoskeletal conditions.
Structure:
The QuickDASH consists of 11 items derived from the original 30-item DASH questionnaire. Items assess:
Difficulty performing common physical tasks. Severity of upper-extremity symptoms. Impact on sleep, work, and social activities
Optional modules (Work and Sports/Performing Arts) may each be added as separate 4-item scales if relevant.
Response Scale:
Likert scale ranging from 1 (No difficulty / No symptom) to 5 (Unable to do / Extreme symptom)
Scoring:
Items are averaged, converted to a 0-100 scale using the formula:
((mean score - 1) × 25)
Total score range: 0-100, where higher scores indicate greater disability and worse upper-extremity function.
Measured: 6-months
Foot and Ankle Outcome Score (FAOS): Function
The Foot and Ankle Outcome Score (FAOS) functional score is a validated measure designed to assess the functional limitations of the foot and ankle
Structure:
The functional portion of the FAOS consists of 17 items related to activities of Daily Living
Response Scale:
Each item is scored using a 5-point Likert scale ranging from:
0 (No problems) - 4 (Extreme problems)
Scoring:
Each subscale scores are transformed to a 0-100 scale using:
Individual scores are totaled 100 - (((functional score total) × 100) /68) Score range per subscale: 0-100, where 100 represents no symptoms and full function, and 0 represents extreme symptoms and maximal functional limitations
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start23 Jul 2024
- Primary completion5 May 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for HemarthrosisStudies 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
- Masking
- None (open label)
- Enrolment
- 14 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543368
- Sponsor's protocol ID
- 00177846
- Status last verified
- Nov 2025
- First submitted
- 29 Jul 2024
- Last updated
- 26 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nie LY, Zhao K, Ruan J, Xue J. Effectiveness of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Clinical Trials. Orthop J Sports Med. 2021 Mar 2;9(3):2325967120973284. doi: 10.1177/2325967120973284. eCollection 2021 Mar.
PubMed 33718505Chu 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 28012636Tan J, Chen H, Zhao L, Huang W. Platelet-Rich Plasma Versus Hyaluronic Acid in the Treatment of Knee Osteoarthritis: A Meta-analysis of 26 Randomized Controlled Trials. Arthroscopy. 2021 Jan;37(1):309-325. doi: 10.1016/j.arthro.2020.07.011. Epub 2020 Jul 15.
PubMed 32679294Baria MR, Vasileff WK, Borchers J, DiBartola A, Flanigan DC, Plunkett E, Magnussen RA. Treating Knee Osteoarthritis With Platelet-Rich Plasma and Hyaluronic Acid Combination Therapy: A Systematic Review. Am J Sports Med. 2022 Jan;50(1):273-281. doi: 10.1177/0363546521998010. Epub 2021 Apr 8.
PubMed 33831332Gualtierotti R, Solimeno LP, Peyvandi F; Ultrasound in hemophilic arthropathy study group. Ultrasound evaluation of hemophilic arthropathy: a proposal of definitions in a changing landscape. Res Pract Thromb Haemost. 2024 Jan 3;8(1):102314. doi: 10.1016/j.rpth.2023.102314. eCollection 2024 Jan.
PubMed 38322151Caviglia H, Landro ME, Daffunchio C, Galatro G, Douglas Price AL, Salgado P, Neme D. Platelet Rich Plasma for Chronic Synovitis Treatment in Patients with Haemophilia. Haemophilia. 2017 Jul;23(4):613-619. doi: 10.1111/hae.13212. Epub 2017 May 4.
PubMed 28470911Piuzzi NS, Ng M, Kantor A, Ng K, Kha S, Mont MA, Muschler GF. What Is the Price and Claimed Efficacy of Platelet-Rich Plasma Injections for the Treatment of Knee Osteoarthritis in the United States? J Knee Surg. 2019 Sep;32(9):879-885. doi: 10.1055/s-0038-1669953. Epub 2018 Sep 6.
PubMed 30189436Chu 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 30300216D'Angiolella LS, Cortesi PA, Rocino A, Coppola A, Hassan HJ, Giampaolo A, Solimeno LP, Lafranconi A, Micale M, Mangano S, Crotti G, Pagliarin F, Cesana G, Mantovani LG. The socioeconomic burden of patients affected by hemophilia with inhibitors. Eur J Haematol. 2018 Oct;101(4):435-456. doi: 10.1111/ejh.13108. Epub 2018 Jul 27.
PubMed 29889317O'Hara J, Hughes D, Camp C, Burke T, Carroll L, Diego DG. The cost of severe haemophilia in Europe: the CHESS study. Orphanet J Rare Dis. 2017 May 31;12(1):106. doi: 10.1186/s13023-017-0660-y.
PubMed 28569181Beitzel K, Allen D, Apostolakos J, Russell RP, McCarthy MB, Gallo GJ, Cote MP, Mazzocca AD. US definitions, current use, and FDA stance on use of platelet-rich plasma in sports medicine. J Knee Surg. 2015 Feb;28(1):29-34. doi: 10.1055/s-0034-1390030. Epub 2014 Sep 30.
PubMed 25268794Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
PubMed 31078660McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
PubMed 24462672Singh H, Knapik DM, Polce EM, Eikani CK, Bjornstad AH, Gursoy S, Perry AK, Westrick JC, Yanke AB, Verma NN, Cole BJ, Chahla JA. Relative Efficacy of Intra-articular Injections in the Treatment of Knee Osteoarthritis: A Systematic Review and Network Meta-analysis. Am J Sports Med. 2022 Sep;50(11):3140-3148. doi: 10.1177/03635465211029659. Epub 2021 Aug 17.
PubMed 34403285
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Cost Platelet-Rich Plasma Injection for the Management of Hemarthropathy
- ClinicalTrials.gov ID
- NCT06543368
- Acronym / sponsor ID
- 00177846
- Conditions
- Hemarthrosis, Hemophilia
- Keywords
- Hemophilia, Hemarthrosis, PRP, Platelet Rich Plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Posted 27 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Orthopedic complications can be injuries or diseases that affect the bones, muscles, and joints. Hemarthropathy is due to bleeding disorders, most commonly hemophilia, and can result in severe issues related to chronic amounts of blood in the body's joints. This causes swelling, pain, and loss of joint function. A serious barrier to treating many patients with bleeding disorders creates higher health risks and costs. Platelet-rich plasma (PRP) injection is a method that can reduce the cost of care while still offering a similar standard of care for patients.
This study intends to show that low-cost PRP can be done safely in patients with bleeding disorders, without the need for expensive equipment, while monitoring patient treatment results. Study participants will receive injections for joint conditions. Being in the study requires attending 1 to 2 in-person visits at the study clinic. Participants will also complete surveys using email, text messages, in person, and/or on the phone. Participation lasts about 6 months.
Detailed description
This study will be performed as a prospective, single arm study. Consecutive patients eligible for a standard-of-care injection will be enrolled from the Utah Center for Bleeding and Clotting Disorders. The University of Utah non-operative sports medicine team currently performs hundreds of injections monthly, and the PI works closely with the orthopedic complaints of patients with bleeding disorders. From a research standpoint, the investigators have successfully performed numerous randomized controlled prospective trials on a variety of musculoskeletal conditions in the past and have already validated this method on a large cohort of patients with knee osteoarthritis (OA).
Potential subjects will then be approached by a member of the research team to discuss the consideration of taking part in the study if they meet the inclusion criteria of this study project. Using all forms of good clinical practice, a member of the study team will review with the participant the Informed Consent Form, allow participant to read the informed consent (ICF) and ask questions prior to signing the ICF. Potential subjects may also be asked by other physicians or staff members familiar with the study.
Low Cost-Platelet Rich Plasma (LC-PRP) preparation method: See Documents for full details. This method follows the same procedures as the standard-of-care, FDA-cleared method used by numerous commercial machines; thus it does not require additional FDA clearance or approval. To summarize the full method in the appendix, 45mL of blood is drawn from the subject in a standard-of-care manner into 3 x 20mL syringes, each containing 2mL of sodium citrate (anticoagulant). Each syringe is prepared and capped, then placed into a centrifuge. The resulting separated blood is then drawn off into a single new sterile syringe, which can be used for the injection. Blood and PRP analysis: The investigators will perform a full analysis (a complete blood count (CBC) with differential) on subjects' whole blood and their prepared LC-PRP. Importantly, the investigators will include all data required in the PRP minimum reporting standards, including "platelet, differential leukocyte, and red cell analysis of all samples." Also note that although the investigators are collecting these values for the purposes of the study, CBC values are not needed in the community.
Injections: A total of 20 joints (estimated 10-15 patients) will receive injections, performed at day 0 and 3 weeks, for a total of two injections - two injections have demonstrated superior outcomes to one, and will increase our number of injections to improve the proof of feasibility. All subjects will receive ultrasound-guided intra-articular joint injections by an experienced sports medicine provider after local anesthesia with 1% lidocaine to the extra-articular structures, namely the skin and joint capsule, to increase comfort. Note: though the investigators are using ultrasound guidance to ensure that they are guaranteeing accurate injectate placement for this study, this is not necessarily required in the community setting. These will be performed after the patient's typical factor infusions, if applicable.
Questionnaire: The investigators will collect demographic information along with baseline and subsequent functional patient reported outcomes, namely the WOMAC (knee), FAOS (ankle), and the QuickDASH (elbow). REDCap will be used to administer surveys and store data. The investigators will additionally ask about adverse events, pain, global satisfaction, global injection satisfaction, and medications.
Data collection time points and follow-up: Follow-up data (see timeline below) will be administered electronically. Subjects will be queried by email, text message, in person, and/or by telephone regarding treatment outcomes at 0, 1, 3, and 6 months after the second injection. Three months will be the primary endpoint, and six months will be an exploratory, unfunded endpoint.
- LC-PRP Outcomes: As this is a feasibility study, it is likely that this study will be underpowered for clinical outcomes. However, the investigators will still monitor pain and the above outcome measures and identify potential time-related improvements.
- Economic Evaluation: The investigators will track staff-, time-, equipment-, and supply-related costs to accurately identify costs associated with each injection. This will ensure that costs are accurately recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRP Injection | Experimental | Biological: Intra articular PRP Injection45mL of blood is drawn from the subject in a standard-of-care manner into 3 x 20mL syringes, each containing 2mL of sodium citrate (anticoagulant). Each syringe is prepared and capped, then placed into a centrifuge. The resulting separated blood is then drawn off into a single new sterile syringe, which can be used for the injection. Blood and PRP analysis: We will perform a full analysis (a complete blood count [CBC] with differential) on subjects' whole blood and their prepared LC-PRP. Importantly, we will include all data required in the PRP minimum reporting standards, including "platelet, differential leukocyte, and red cell analysis of all samples." |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of any adult age with symptomatic hemarthropathy of the ankle, knee, or elbow, based on radiographs within the last 24 months.
- Patients must have failed at least six weeks of conventional conservative treatments (such as medication or physical therapy).
Key exclusion criteria (9 listed)
- Exclusion criteria will include recent (last two years) surgery to the affected joint, prior joint replacement.
- Prior orthobiologic injection into the affected joint.
- Thrombocytopenia
- Inability to receive factor prior to PRP injection.
- Active systemic 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 PRP InjectionA total of 20 joints (estimated 10-15 patients) will receive injections, performed at day 0 and 3 weeks, for a total of two injections - two injections have demonstrated superior outcomes to one, and will increase our number of injections to improve the proof of feasibility. All subjects will receive ultrasound-guided intra-articular joint injections by an experienced sports medicine provider after local anesthesia with 1% lidocaine to the extra-articular structures, namely the skin and joint capsule, to increase comfort. | Biological | PRP Injection |
Primary outcome
Global Satisfaction (Numeric Rating System)
Time frame: 6-months
Global patient satisfaction was assessed prospectively at 6 months following the intervention using a numeric rating scale ranging from 0 to 100. Participants were asked to rate their overall satisfaction with the treatment outcome, where 0 represented "not satisfied" and 100 represented "completely satisfied." The score reflects the participant's overall perception of their injection, including symptom improvement and overall experience.
3 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 6-months
Quick Disabilities of Arm Shoulder and Hand (QuickDASH)
Time frame: 6-months
Foot and Ankle Outcome Score (FAOS): Function
Time frame: 6-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33718505Nie LY, Zhao K, Ruan J, Xue J. Effectiveness of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Clinical Trials. Orthop J Sports Med. 2021 Mar 2;9(3):2325967120973284. doi: 10.1177/2325967120973284. eCollection 2021 Mar.
- 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 32679294Tan J, Chen H, Zhao L, Huang W. Platelet-Rich Plasma Versus Hyaluronic Acid in the Treatment of Knee Osteoarthritis: A Meta-analysis of 26 Randomized Controlled Trials. Arthroscopy. 2021 Jan;37(1):309-325. doi: 10.1016/j.arthro.2020.07.011. Epub 2020 Jul 15.
- Background: PubMed 33831332Baria MR, Vasileff WK, Borchers J, DiBartola A, Flanigan DC, Plunkett E, Magnussen RA. Treating Knee Osteoarthritis With Platelet-Rich Plasma and Hyaluronic Acid Combination Therapy: A Systematic Review. Am J Sports Med. 2022 Jan;50(1):273-281. doi: 10.1177/0363546521998010. Epub 2021 Apr 8.
- Background: PubMed 38322151Gualtierotti R, Solimeno LP, Peyvandi F; Ultrasound in hemophilic arthropathy study group. Ultrasound evaluation of hemophilic arthropathy: a proposal of definitions in a changing landscape. Res Pract Thromb Haemost. 2024 Jan 3;8(1):102314. doi: 10.1016/j.rpth.2023.102314. eCollection 2024 Jan.
- Background: PubMed 28470911Caviglia H, Landro ME, Daffunchio C, Galatro G, Douglas Price AL, Salgado P, Neme D. Platelet Rich Plasma for Chronic Synovitis Treatment in Patients with Haemophilia. Haemophilia. 2017 Jul;23(4):613-619. doi: 10.1111/hae.13212. Epub 2017 May 4.
- Background: PubMed 30189436Piuzzi NS, Ng M, Kantor A, Ng K, Kha S, Mont MA, Muschler GF. What Is the Price and Claimed Efficacy of Platelet-Rich Plasma Injections for the Treatment of Knee Osteoarthritis in the United States? J Knee Surg. 2019 Sep;32(9):879-885. doi: 10.1055/s-0038-1669953. Epub 2018 Sep 6.
- 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 PRP Injection in people with Hemarthrosis and Hemophilia, 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 2 inclusion and 9 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 26 May 2026. 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?
Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Global Satisfaction (Numeric Rating System) (time frame: 6-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 NCT06543368, which also lists 36 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 26 May 2026.