BARB Study

Study Overview

A prospective, multicenter cohort study establishing a registry to analyze the cellular and immunoregulatory profile of platelet-rich plasma preparations used to treat knee osteoarthritis.

Sponsor

Lead site Mayo Clinic; Principal Investigator Dr. Cole. Funded by the Rush Department of Orthopedics. (N=80)

Research Type

Prospective, multi-center cohort registry study

Candidate Criteria

Adults age 18 or older at the time of consent with a diagnosis of osteoarthritis (Kellgren Lawrence grade 1 to 4) who have chosen elective PRP therapy.

Purpose

To characterize the cell and immunoregulatory factor profile in PRP preparations, and in synovial fluid when effusion is present, and to correlate these findings to patient-reported pain and function outcomes.

Study Design

Patients receive an elective PRP injection at their baseline clinic visit using the Arthrex ACP kit. The study combines retrospective chart abstraction with prospective patient-reported outcomes, including KOOS, PROMIS Pain Interference, PROMIS Physical Function, SANE, VAS, and Tegner scores.

Study Procedures

1. Baseline clinic visit: elective PRP injection
2. Retrospective chart abstraction
3. Patient-reported outcomes sent through Patient IQ at:
   • Baseline
   • 6 weeks
   • 3 months
   • 6 months
   • 12 months
   • 24 months