Flannery, Sean W. http://orcid.org/0000-0003-0495-2626
Murray, Martha M.
Badger, Gary J.
Ecklund, Kirsten
Proffen, Benedikt
Sant, Nicholas
Portilla, Gabriela
Sanborn, Ryan
Freiberger, Christina
Rachael, Rachael
Barnett, Samuel
Yen, Yi-Meng
Micheli, Lyle
Kramer, Dennis E.
Fleming, Braden C. http://orcid.org/0000-0002-7841-425X
Kiapour, Ata M. http://orcid.org/0000-0001-7742-5769
,
Funding for this research was provided by:
Boston Children's Hospital Translational Research Program
Children’s Hospital Orthopaedic Surgery Foundation
Children’s Hospital Sports Medicine Foundation
Football Players Health Study at Harvard University
National Institutes of Health (R01-AR065462, R01-AR056834, P30-GM122732)
Lucy Lippitt Endowment of Brown University
Article History
Received: 1 December 2021
Accepted: 4 May 2022
First Online: 15 June 2022
Declarations
:
: MMM, AMK, BCF (Miach Orthopaedics); BCF and AMK (AJSM). One or more of the authors has declared the following potential conflict of interest: MMM is a founder and equity holder in Miach Orthopaedics, Inc, which was formed to upscale production of the BEAR scaffold. MMM maintained a conflict-of-interest management plan that was approved by Boston Children’s Hospital and Harvard Medical School during the conduct of the trial, with oversight by both conflict-of-interest committees and the institutional review board of Boston Children’s Hospital, as well as the US Food and Drug Administration. AMK is a paid consultant of Miach Orthopaedics. DEK is a paid consultant for Miach Orthopaedics, Johnson & Johnson, and receives educational support from Kairos Surgical. BCF is an associate editor for The American Journal of Sports Medicine, a founder of Miach Orthopaedics, and the spouse of MMM who has the added conflicts. A conflict-of-interest management plan for BCF was implemented by Rhode Island Hospital during the course of this study.
: Informed consent was obtained following IRB approval (IRB P00021470). Author contributions: SWF and GJB performed statistical analyses. AMK performed image processing. MMM, KE, DEK, and BEAR Trial Team designed and collected the BEAR clinical trial data. SWF, MMM, BCF, AMK conceived and designed the study. SWF, AMK and BCF drafted the manuscript. All authors read and approved the final manuscript.