RecruitingPhase 4NCT06793982

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

Sponsor

LifeBridge Health

Enrollment

54 participants

Start Date

Feb 21, 2024

Study Type

INTERVENTIONAL

Conditions

hip osteoarthritis

Summary

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.

Eligibility

Min Age: 21 YearsMax Age: 80 Years

Inclusion Criteria5

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 Criteria9

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

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Interventions

DEVICEPlatelet Rich Plasma Joint Injection

Magellan Autologous Concentration System, ISTO Biologics

DRUGCorticosteroid Injection

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