drugset / Trial / NCT05742763

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

NCT05742763 ↗

Phase 1/2 Withdrawn QC Kinetix LLC
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2023-11-01
Primary completion
2024-10-07
Completion
2024-10-07

Outcome

Outcome not reported

Stopped (Enrollment): “The study format without a crossover option for study participants enrolled in the control arm wasn't attractive to patients and we were unable to enroll any patients since enrollment began earlier this year, so the study will be withdrawn.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule — —
Subject Ibuprofen Small molecule — —
Background Platelet Rich Plasma Other / unclassified — Other

Indications