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NCT Number: NCT06793982

Platelet Rich Plasma Versus Corticosteroids in Hip Osteoarthritis Pain

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.

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location status: Recruiting

Location contact

Martin Gesheff, DHSc

CONTACT

[email protected]

410-601-9467

Michael A Mont, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet Rich Plasma Joint Injection

Device

Magellan Autologous Concentration System, ISTO Biologics

Corticosteroid injection

Drug

5 milliliters (mL) injection of corticosteroid (1cc Kenalog, 4cc Xylocaine) Kenalog - 40 (triamcinolone acetonide injectable suspension, USP) Xylocaine - MPF (lidocaine HCl Injection, USP)

Primary outcomes

  1. Pain Score VAS

    Time frame: baseline, six weeks, and three months

    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.

Secondary outcomes

  1. Pain Score NRS

    Time frame: baseline, six weeks, and three months.

    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.

  2. Functional score HOOS

    Time frame: baseline, six weeks, and three months

    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.

  3. Functional score HHS

    Time frame: baseline, six weeks, and three months

    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.

  4. Functional score WOMAC

    Time frame: baseline, six weeks, and three months

    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.

  5. Pain Medication Adherence

    Time frame: Baseline through three months

    Measured by number of days until pain medication (acetaminophen) is not adequate.

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Gesheff, DHSc

CONTACT

[email protected]

410-601-9467

Sponsors and collaborators

Lead sponsor

LifeBridge Health

Other

Collaborators

  • Hip Society

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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