Trial Outcomes & Findings for Low-Cost Platelet-Rich Plasma for Hemarthropathy (NCT NCT06543368)

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.

This was an open-label study; therefore, no randomization was performed. The joint enrolled was selected collaboratively by the principal investigator and the patient, based on which joint was causing the greatest symptoms. In some cases, participants had more than one joint enrolled (e.g., one knee and one ankle), accounting for the difference between the number of participants (n=14) and the number of units/joints enrolled (n=20).

Unit of analysis: Joints

14 participants were enrolled, however some participants had multiple joints injected.

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.

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.

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.

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