Platelet Rich Plasma Versus Corticosteroids in Hip Osteoarthritis Pain

Phase 4RecruitingNCT06793982

LifeBridge Health54 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hip Osteoarthritis

Interventions

Platelet Rich Plasma Joint InjectionDEVICE

Magellan Autologous Concentration System, ISTO Biologics

Corticosteroid InjectionDRUG

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: baseline, six weeks, and three months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: baseline, six weeks, and three months

Central Contacts

Martin Gesheff, DHSc

CONTACT

410-601-9467 mgesheff@lifebridgehealth.org

Data from ClinicalTrials.gov

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