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Recruiting NCT06793982

Platelet Rich Plasma Versus Corticosteroids in Hip Osteoarthritis Pain

Phase IV Interventional Hip Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Platelet Rich Plasma Joint Injection, Corticosteroid Injection.
Who it may be relevant to
Registry conditions: Hip Osteoarthritis. Basic parameters: 21 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Efficacy of Platelet Rich Plasma Compared With Corticosteroid Injections for the Treatment of Pain Associated With Hip Osteoarthritis

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.

Detailed 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.

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)

Primary outcome measures

  • Pain Score VAS [Time frame: baseline, six weeks, and three months]
Secondary outcome measures (5)
  • Pain Score NRS [Time frame: baseline, six weeks, and three months.]
  • Functional score HOOS [Time frame: baseline, six weeks, and three months]
  • Functional score HHS [Time frame: baseline, six weeks, and three months]
  • Functional score WOMAC [Time frame: baseline, six weeks, and three months]
  • Pain Medication Adherence [Time frame: Baseline through three months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Sinai Hospital of Baltimore — Baltimore

Identifiers

NCT: NCT06793982 · 2084137

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗