NCT06703970

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2024

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

2.5 years

First QC Date

November 20, 2024

Last Update Submit

November 21, 2024

Conditions

Knee Osteoarthritis (OA)

Keywords

platelet rich plasmaknee OAPRPcorticosteroidsosteoarthritisknee osteoarthritis

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 (4)

  • Pain Score NRS

    Baseline, six weeks, and three months.

  • Functional score KOOS

    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

\~3 milliliters (mL) injection of autologous PRP prepared with the 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

Corticosteroid InjectionDRUG

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

Corticosteroid
Platelet Rich Plasma Joint InjectionDEVICE

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

Autologous Platelet Rich Plasma

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 knee osteoarthritis
  • Indicated for a knee injection to treat knee OA symptoms

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
not applicable
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

November 20, 2024

First Posted

November 25, 2024

Study Start

February 2, 2022

Primary Completion

July 16, 2024

Study Completion

July 16, 2024

Last Updated

November 25, 2024

Record last verified: 2024-11

Locations

US(1)