Summary

The results of this study suggest that qualitative conclusions and outcome scores were found to not be associated with industry affiliation in randomized controlled trials with PRP.

Abstract

Purpose

Industry funding and corporate sponsorship have played a significant role in the advancement of medical research and technology. However, this relationship raises concerns of how industry association may bias research findings and influence perception of results. As novel therapies continue to emerge, it is necessary to evaluate the literature for reliable and evidence-based clinical research before implementing these therapies into practice. The purpose of this study was to determine whether industry affiliation plays a role in the outcome of randomized controlled trial (RCT) studies investigating platelet-rich plasma (PRP) versus hyaluronic acid (HA), corticosteroids (CS), or placebo for knee osteoarthritis (OA).

Methods

A search of the PubMed, Cochrane, and MEDLINE databases for RCTs of Level 1 or 2 evidence published from 2011 to present comparing PRP versus HA, CS or placebo for the treatment of knee OA was performed by two independent reviewers. To determine industry affiliation, the conflicts of interest, funding and disclosure segments of publications were assessed and all authors were reviewed through the AAOS Disclosure and Open Payments databases. Industry affiliation by financial conflicts of interest were identified as license or royalty fees, paid consultant fees, advisory position or speaker, employee, stock options, or research funding from companies that synthesize PRP or manufacture devices to administer PRP. Studies were classified as industry affiliated (IA) or non-industry affiliated (NIA). The outcomes of each study were rated as favorable, analogous, or unfavorable according to predefined criteria based on previously published protocols and also statistical significance by comparing patient reported outcome measures. Favorable studies showed superior results, analogous studies demonstrated no significant difference, and unfavorable studies had inferior outcomes when comparing PRP to HA, CS or placebo.

Results

A total of 37 (6 IA and 31 NIA) studies were available for analysis. All studies were of level 1 (67.6%) or level 2 (32.4%) evidence, with no statistically significant difference between IA and NIA studies (p = 0.4443). Nineteen (51.4%) studies reported PRP as favorable compared to other treatments, while 18 (48.6%) studies showed no significant differences between PRP and other treatments. No studies showed worse outcomes with PRP compared to HA, CS, or placebo. There was no significant difference in qualitative conclusions between the IA and NIA cohorts, with the IA cohort having 3 favorable studies and 3 analogous studies, while the NIA group included 16 favorable studies and 15 analogous studies (p = 0.8881). When comparing IA versus NIA studies, using 6 and 12-month WOMAC and IKDC scores, there were no significant differences in outcome measures.

Conclusion

The results of this study demonstrate largely favorable and analogous results with PRP compared to other intra-articular injection therapies for knee OA in randomized controlled trial studies. Qualitative conclusions and outcome scores were found to not be associated with industry affiliation. Although the results of this study suggest there is no influence of industry association on RCTs involving PRP, it is still necessary to carefully evaluate pertinent corporate affiliations in published literature.