Recruiting

Platelet Rich Plasma vs. Corticosteroids

Sponsor:

LifeBridge Health

Code:

NCT06793982

Conditions

Hip Osteoarthritis

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Platelet Rich Plasma Joint Injection

Corticosteroid Injection

Study Details

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

Study ID

NCT06793982

Start date

Feb 21, 2024

Status verified date

Mar, 2025

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Autologous Platelet Rich Plasma

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

active comparator: Corticosteroid

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

Interventions

Platelet Rich Plasma Joint Injection

Magellan Autologous Concentration System, ISTO Biologics

Corticosteroid Injection

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

Primary outcome measure

  • Pain Score VAS [ Time Frame: baseline, six weeks, and three months ]

Central Contacts and Locations

Central contacts

Martin Gesheff, DHSc

410-601-9467mgesheff@lifebridgehealth.org

Locations

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Martin Gesheff, DHSc

410-601-9467mgesheff@lifebridgehealth.org

Principal Investigator:

Michael A Mont, MD

More Information

Sponsor

LifeBridge Health

Last update posted

Mar 14, 2025

Last verified

Mar, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by LifeBridge Health on 2025-03-14.