Platelet Rich Plasma Versus Corticosteroids in Knee Osteoarthritis Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-02

Study Completion Date

2024-07-16

Brief Summary

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Prospective, multi-center, randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of knee osteoarthritis. The purpose of the study is to determine which therapy provides a greater reduction in patient reported outcome measures of pain and function.

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Detailed Description

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Platelet rich plasma has become increasingly utilized as a treatment option for knee osteoarthritis. Corticosteroids is currently an approved medication to treat the symptoms of the knee osteoarthritis. There is limited evidence in a prospective randomized manner powered adequately to determine a difference between these treatments for pain associated with knee osteoarthritis.

Prospective, multi-center, single blind (participant), randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of knee 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

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Knee Osteoarthritis (OA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Autologous Platelet Rich Plasma

\~3 milliliters (mL) injection of autologous PRP prepared with the Magellan Autologous Concentration System, ISTO Biologics

Group Type EXPERIMENTAL

Platelet Rich Plasma Joint Injection

Intervention Type DEVICE

\~3 milliliters (mL) injection of autologous PRP Magellan Autologous Concentration System, ISTO Biologics

Corticosteroid

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

Group Type ACTIVE_COMPARATOR

Corticosteroid Injection

Intervention Type DRUG

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

Interventions

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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)

Intervention Type DRUG

Platelet Rich Plasma Joint Injection

\~3 milliliters (mL) injection of autologous PRP Magellan Autologous Concentration System, ISTO Biologics

Intervention Type DEVICE

Eligibility Criteria

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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 knee osteoarthritis
* Indicated for a knee injection to treat knee OA symptoms

Exclusion Criteria

* Any injections into the target knee 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No