Platelet Rich Plasma Versus Corticosteroids in Knee Osteoarthritis Pain

The Efficacy of Platelet Rich Plasma Compared with Corticosteroid Injections for the Treatment of Pain Associated with Knee Osteoarthritis

Prospective, multi-center, randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of knee osteoarthritis. The purpose of the study is to determine which therapy provides a greater reduction in patient reported outcome measures of pain and function.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis (OA)
• Intervention / Treatment: Device: Platelet Rich Plasma Joint Injection; Drug: Corticosteroid Injection

Detailed Description

Platelet rich plasma has become increasingly utilized as a treatment option for knee osteoarthritis. Corticosteroids is currently an approved medication to treat the symptoms of the knee osteoarthritis. There is limited evidence in a prospective randomized manner powered adequately to determine a difference between these treatments for pain associated with knee osteoarthritis.

Prospective, multi-center, single blind (participant), randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of knee osteoarthritis. The purpose of the study is to determine which therapy provides a greater reduction in patient reported outcome measures of pain and function.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 21-80 years
• Radiographic diagnosis of Kellgren-Lawrence (KL) grade of II or III knee osteoarthritis
• Indicated for a knee injection to treat knee OA symptoms

Exclusion Criteria:

• Any injections into the target knee within three months
• Current overlying skin infection
• Current or previous diagnosis of "chronic pain"
• Opioid tolerant at time of screening (for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.)
• Allergy to any potential ingredients or medications utilized in any of the two groups
• Treatment with another investigational drug or other intervention for pain
• Diagnosis of Diabetes Mellitus
• If female, pregnant or planning to be pregnant within the following 3 months or study duration
• Any condition(s) or diagnosis, both physical or psychological, or physical exam finding in the opinion of the investigator that would precludes participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous Platelet Rich Plasma; ~3 milliliters (mL) injection of autologous PRP prepared with the Magellan Autologous Concentration System, ISTO Biologics	Device: Platelet Rich Plasma Joint Injection; ~3 milliliters (mL) injection of autologous PRP Magellan Autologous Concentration System, ISTO Biologics
Active Comparator: Corticosteroid; 5 milliliters (mL) injection of corticosteroid (1cc Kenalog, 4cc Xylocaine) Kenalog - 40 (triamcinolone acetonide injectable suspension, USP) Xylocaine - MPF (lidocaine HCl Injection, USP)	Drug: Corticosteroid Injection; 5 milliliters (mL) injection of corticosteroid (1cc Kenalog, 4cc Xylocaine) Kenalog - 40 (triamcinolone acetonide injectable suspension, USP) Xylocaine - MPF (lidocaine HCl Injection, USP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score VAS	Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Pain intensity that is calculated by measuring the distance from the "no pain" end of a line to a mark placed by the patient to indicate their current pain level. This will be measured at baseline, six weeks, and three months.	Baseline, six weeks, and three months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score NRS	Numeric Pain Rating Scale (NRPS) where patients are asked to rate their pain on a scale of 0 to 10, with 0 representing "no pain" and 10 representing "the worst pain imaginable. This will be measured at baseline, six weeks, and three months.	Baseline, six weeks, and three months.
Functional score KOOS	Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. KOOS is used for any knee pathology and was found to be useful in assessing patients of various age populations, ranging from young to elderly adults. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. This will be measured at baseline, six weeks, and three months.	Baseline, six weeks, and three months.
Functional score WOMAC	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright. The total WOMAC score is the sum of the three subscale scores, with a possible score range of 0-96. Higher scores indicate worse pain, stiffness, and functional limitations. This will be measured at baseline, six weeks, and three months.	Baseline, six weeks, and three months.
Pain Medication Adherence	Measured by number of days until pain medication (acetaminophen) is not adequate.	Baseline through three months.

Collaborators and Investigators

• Sponsor: LifeBridge Health

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Actual): July 16, 2024
• Study Completion (Actual): July 16, 2024

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Estimated): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: osteoarthritis; knee osteoarthritis; platelet rich plasma; corticosteroids; PRP; knee OA
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 1842031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes