Platelet Rich Plasma Versus Corticosteroids in Hip Osteoarthritis Pain

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

Prospective, single-center that may go on to being multicenter, randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of Hip 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: Recruiting
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Drug: Corticosteroid Injection; Device: Platelet Rich Plasma Joint Injection

Detailed Description

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

Prospective, single center that may go on to be multi-center, single blind (participant), randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of Hip 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 (Estimated): 54
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Martin Gesheff, DHSc; Phone Number: 410-601-9467; Email: mgesheff@lifebridgehealth.org

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Recruiting
      • Sinai Hospital of Baltimore
      • Contact: Martin Gesheff, DHSc; Phone Number: 410-601-9467; Email: mgesheff@lifebridgehealth.org
      • Contact: Michael A Mont, MD

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 Hip osteoarthritis
• Indicated for a Hip injection to treat Hip OA symptoms

Exclusion Criteria:

• Any injections into the target Hip 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
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)
Experimental: Autologous Platelet Rich Plasma; ~Injection of approximately 10 mL autologous PRP Magellan Autologous Concentration System, ISTO Biologics	Device: Platelet Rich Plasma Joint Injection; Magellan Autologous Concentration System, ISTO Biologics

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 HOOS	The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess patient's opinions about their hip and associated problems and to evaluate their symptoms and functional limitations during a therapeutic process. The HOOS includes 40 items with five possible responses, graded from 0 to 4 (0 points = worst possible score; 100 points = best possible score). Standardized answer options are given in 5 Likert boxes with scores from 0 to 4 (no, mild, moderate, severe and extreme) to answer the questions. This will be measured at baseline, six weeks, and three months.	baseline, six weeks, and three months
Functional score HHS	The Harris Hip Scale (HHS) was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The maximum score possible is 100. Results can be interpreted with the following[1]: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent. 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
• Collaborators: Hip Society

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: platelet rich plasma; PRP; Corticosteroids; hip osteoarthritis; hip OA
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 2084137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes