Low-Cost Platelet-Rich Plasma for Hemarthropathy

NCT06543368 | Completed Results

• 1 other identifier: 00177846
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hemarthrosis; Hemophilia

Keywords

Hemophilia; Hemarthrosis; PRP; Platelet Rich Plasma

Outcome Measures

Primary Outcomes (1)

• 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.

  6-months

Secondary Outcomes (3)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  6-months

• Quick Disabilities of Arm Shoulder and Hand (QuickDASH)

  6-months

• Foot and Ankle Outcome Score (FAOS): Function

  6-months

Study Arms (1)

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."

Biological: Intra articular PRP Injection

Interventions

Intra articular PRP Injection BIOLOGICAL

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.

PRP Injection

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 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).

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (36)

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MeSH Terms

Conditions

Hemarthrosis; Hemophilia A

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

This study was a single-arm pilot with a small sample size and no control group, limiting the ability to draw causal conclusions or evaluate statistical significance. The study population was drawn from a single center, potentially limiting generalizability. Larger, multi-site randomized trials are needed to confirm reproducibility, efficacy, and define optimal dosing strategies.

Results Point of Contact

• Title: Jamie Egbert
• Organization: University of Utah

jamie.egbert@utah.edu

8015871532

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Principal Investigator, Professor

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 9, 2024
• Study Start: July 23, 2024
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2025-11

Locations

US (1)