Clinical Trial Finder

Platelet Rich Plasma Versus Corticosteroids in Hip Osteoarthritis Pain

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 21 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06793982
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 LifeBridge Health
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Hip Osteoarthritis
Additional Details

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.

Arms & Interventions

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

Device: - Platelet Rich Plasma Joint Injection

Magellan Autologous Concentration System, ISTO Biologics

Drug: - 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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sinai Hospital of Baltimore, Baltimore, Maryland

Status

Recruiting

Address

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215

Site Contact

Martin Gesheff, DHSc

[email protected]

410-601-9467

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