Platelet-Rich Plasma and the Effects of NSAIDs on Pain and Functional Scores in Knee Osteoarthritis

Summary

The primary research purpose is to determine if the use of a drug therapy intervention (each study participant will be randomly assigned to receive one of 3 study medications which will be blinded from everyone, including the study participants, and all research staff (except the principal investigator), combined with a series of 3 injections of Platelet-Rich Plasma (PRP) into an osteoarthritic knee joint, leads to reductions in knee pain, and improvements in physical function. Improvements will be assessed by serially evaluating pain scores and functionality using standardized and validated questionaires which will be completed by the study participant at each clinic office visit. In addition, blood tests will be drawn at each visit to evalute any changes in blood compostion. If the participant meets the study inclusion and exclusion criteria and agrees to attend 7 follow up office visits, they will be eligble to enroll in the study. If they wish to volunarily enroll in the study, it will be explained in detail, afterwhich all questions and any concerns will be answered. Each office visit will take between 30-45 minutes and will take place over a 12-month study period comittment.

Conditions

• Osteoarthritis of the Knee
• Degenerative Osteoarthritis
• Knee Pain Chronic

Interventions

COMBINATION_PRODUCT

Ibuprofen and PRP

The primary research purpose is to determine if the use of ibuprofen \[arm #1\] vs acetaminophen \[arm #2\] vs a placebo control group \[arm #3\] with the intervention of a series of three injections of LP-PRP into the knee joint, leads to significantly greater reductions in average knee pain severity, and increases in physical function and quality of life, in patients with symptomatic moderate KOA, and grade 2 or 3 radiographic changes defined by the Kellgren-Lawrence (K-L) classification system.

COMBINATION_PRODUCT

Acetaminophen and PRP

The primary research purpose is to determine if the use of ibuprofen \[arm #1\] vs acetaminophen \[arm #2\] vs a placebo control group \[arm #3\] with the intervention of a series of three injections of LP-PRP into the knee joint, leads to significantly greater reductions in average knee pain severity, and increases in physical function and quality of life, in patients with symptomatic moderate KOA, and grade 2 or 3 radiographic changes defined by the Kellgren-Lawrence (K-L) classification system.

COMBINATION_PRODUCT

Placebo and PRP

The primary research purpose is to determine if the use of ibuprofen \[arm #1\] vs acetaminophen \[arm #2\] vs a placebo control group \[arm #3\] with the intervention of a series of three injections of LP-PRP into the knee joint, leads to significantly greater reductions in average knee pain severity, and increases in physical function and quality of life, in patients with symptomatic moderate KOA, and grade 2 or 3 radiographic changes defined by the Kellgren-Lawrence (K-L) classification system.

Sponsors & Collaborators

• QC Kinetix LLC

  lead INDUSTRY

Principal Investigators

• Kenneth P Barnes, MD, MSc. · QC Kinetix LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-01

Primary Completion

2024-10-07

Completion

2024-10-07

FDA Drug

Yes

Countries

• United States

Study Locations