Platelet Rich Plasma Versus Corticosteroids in Hip Osteoarthritis Pain

NCT06793982 | Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: 2084137
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hip Osteoarthritis

Keywords

platelet rich plasma; hip osteoarthritis; PRP; hip OA; Corticosteroids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pain Score NRS

  baseline, six weeks, and three months.

• Functional score HOOS

  baseline, six weeks, and three months

• Functional score HHS

  baseline, six weeks, and three months

• Functional score WOMAC

  baseline, six weeks, and three months

• Pain Medication Adherence

  Baseline through three months

Study Arms (2)

Autologous Platelet Rich Plasma

EXPERIMENTAL

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

Device: Platelet Rich Plasma Joint Injection

Corticosteroid

ACTIVE COMPARATOR

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

Interventions

Platelet Rich Plasma Joint Injection DEVICE

Magellan Autologous Concentration System, ISTO Biologics

Autologous Platelet Rich Plasma

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)

Corticosteroid

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LifeBridge Health: lead
• Hip Society: collaborator

Study Sites (1)

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Martin Gesheff, DHSc

CONTACT

410-601-9467; mgesheff@lifebridgehealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Given the nature of this study, blinding will not be possible for the treating surgeon and research staff. The participants will be blinded from the regimen that they receive, and both groups will have blood drawn and the injection will be covered in a manner to ensure participants cannot ascertain the treatment regimen.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 27, 2025
• Study Start: February 21, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)