An interventional study of Intra articular PRP Injection in Hemarthrosis and Hemophilia, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by University of Utah · Not applicable, Interventional, and Treatment
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.
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.
21 studies on the registry are indexed under Hemarthrosis; 5 are open to participants now.
This study's enrollment of 14 is below the median of 22 across 12 interventional studies indexed under Hemarthrosis.
Browse Hemarthrosis studies →University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with hemarthropathy in multiple joints will be eligible for up to 2 joints if multiple fit the criteria.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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."
Biological: Intra articular PRP Injection
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.
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.
Time frame: 6-months
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.
Time frame: 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.
Time frame: 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
Time frame: 6-months
Patients who are eligible for a standard-of-care injection were enrolled from the Utah Center for Bleeding and Clotting Disorders. If the participant appeared to be a candidate, he or she was invited to participate.
| Milestone | PRP Injection |
|---|---|
| Started | 14 |
| Knees assessed | 5 |
| Ankles assessed | 9 |
| Elbows assessed | 3 |
| Completed | 14 |
| Not completed | 0 |
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.
| Scores on a scale | PRP Injection |
|---|---|
| Global Satisfaction (Numeric Rating System) | 70 (35 to 100) |
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.
| Scores on a scale | PRP Injection |
|---|---|
| Total Score | 31 (0 to 73) |
| Pain Subscore | 7 (0 to 18) |
| Stiffness Subscore | 4 (0 to 9) |
| Functionality Subscore | 21 (0 to 46) |
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.
| Scores on a scale | PRP Injection |
|---|---|
| Quick Disabilities of Arm Shoulder and Hand (QuickDASH) | 22.73 (0 to 56.82) |
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
| Scores on a scale | PRP Injection |
|---|---|
| Foot and Ankle Outcome Score (FAOS): Function | 94.12 (84.12 to 100) |
Collected over From enrollment, to 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PRP Injection | 0/20 (0%) | 0/20 (0%) | 9/20 (45%) |
| Event | PRP Injection |
|---|---|
| Increased pain in the jointMusculoskeletal and connective tissue disorders | 5/20 |
| OtherMusculoskeletal and connective tissue disorders | 2/20 |
| Reduced joint range of motionMusculoskeletal and connective tissue disorders | 1/20 |
| New swelling of the joint (not due to joint bleed)Musculoskeletal and connective tissue disorders | 1/20 |
Some participants had two different joints enrolled in the study, which explains the difference between the number of participants and the number of joints analyzed.
| Age, Categorical(Participants) | PRP Injection |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 14 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | PRP Injection |
|---|---|
| Female | 0 |
| Male | 14 |
| Hemophilia Type(Participants) | PRP Injection |
|---|---|
| Hemophilia type A | 12 |
| Hemophilia type B | 2 |
| Hemophilia Severity(Participants) | PRP Injection |
|---|---|
| Mild | 2 |
| Moderate | 1 |
| Severe | 11 |
| Baseline Satisfaction with Joint(Joints) | PRP Injection |
|---|---|
| Very unsatisfied | 3 |
| Unsatisfied | 14 |
| Neither satisfied nor unsatisfied | 1 |
| Satisfied | 2 |
| Very Satisfied | 0 |
| Race and Ethnicity Not Collected(Participants) | PRP Injection |
|---|
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