Platelet Rich Plasma Versus Corticosteroids in Hip Osteoarthritis Pain

LifeBridge Health

Status and phase: Enrolling; Phase 4

Conditions: Hip Osteoarthritis

Treatments: Device: Platelet Rich Plasma Joint Injection; Drug: Corticosteroid Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06793982

2084137

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Autologous Platelet Rich Plasma

Experimental group

Description:

\~Injection of approximately 10 mL autologous PRP Magellan Autologous Concentration System, ISTO Biologics

Treatment:

Device: Platelet Rich Plasma Joint Injection

Corticosteroid

Active Comparator group

Description:

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

Treatment:

Drug: Corticosteroid Injection