Braun, John T. http://orcid.org/0000-0001-6558-0454
Federico, Sofia C.
Lawlor, David M.
Paschos, Nikolaos J.
Croitoru, Daniel P.
Grottkau, Brian E.
Article History
Received: 27 October 2023
Accepted: 1 May 2024
First Online: 26 May 2024
Declarations
:
: Though the lead author (Braun) has several disclosures, there is no conflict of interest. The lead author is a consultant for ZimVie on the current FDA approved tether system (The Tether System) and receives royalties from Zimmer on a pedicle screw based fusion system (Vitality), but neither is the subject of this paper as this study includes only patients treated off-label with the Dynesys System. The lead author is also an FDA consultant for non-fusion devices. None of the other authors have any relevant disclosures.
: This research study was conducted retrospectively from data obtained for clinical purposes. We consulted extensively with the IRBs of both Dartmouth-Hitchcock Medical Center/Giesel Medical School at Dartmouth (#00029300) and Massachusetts General Hospital/Harvard Medical School (#2020P001760) who determined that our study did not require patient consent and could proceed under the standard ethical guidelines of both Dartmouth and Harvard.