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Validation of a Low-cost Platelet-Rich Plasma (PRP)

NCT06184048 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-17

No results posted yet for this study

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, 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.

Conditions

  • Platelet-Rich Plasma (PRP)
  • Knee Osteoarthritis (OA)

Interventions

PROCEDURE

Intra-Articular knee injection of LC-PRP

Blood Collection 45mL, Processed Neutrophil-Poor PRP, 2 Injections at day 0 and 3 weeks.

Sponsors & Collaborators

Principal Investigators

  • Daniel Cushman, MD · University of Utah Orthopedic Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-15
Primary Completion
2024-06-15
Completion
2024-10-10

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06184048 on ClinicalTrials.gov