The use of the DTO™ hybrid dynamic device: a clinical outcome- and radiological-based prospective clinical trial

Abstract

BackgroundThe purpose of this study was to assess the radiological and clinical outcome parameters following lumbar hybrid dynamic instrumentation with the focus on the adjacent segment degeneration (ASD) and adjacent segment disease (ASDi).MethodsIn this prospective trial all patients presenting with degenerative changes to the lumbar spine have been included. Precondition was a stable adjacent level with/without degenerative alteration. The elected patients underwent a standardised fusion procedure with hybrid instrumentation (DTO™, Zimmer Spine Inc., Denver, USA). Patients’ demographics have been documented and the follow-up visits were conducted after 6 weeks, and then stepwise after 6 up to 48 months. Each follow-up visit included assessment of quality of life and pain using specific questionnaires (COMI, SF-36, ODI) and the radiological evaluation with focus on the adjacent level alterations.ResultsAt a mean follow up of 24 months an incidence of ASD with 10.91% and for ASDi with 18.18% has been observed. In 9% a conversion to standardised fusion was needed. There was a high rate of mechanical complication: (1) screw loosening (52.73%), (2) pedicle screw breakage (10.91%), and (3) rod breakage (3.64%) after a follow up of a maximum of 60 months. There were no significant difference of COMI, ODI and SF-36(v2) in comparison to all groups but all 55 patients showed a clinical improvement over the time.ConclusionThe dynamic hybrid DTO™ device is comparable to the long-term results after standardised fusion procedure, while a high rate of mechanical complication decreased the initial benefit.Trial registrationThis trial was registered at the ClinicalTrials Register (#NCT03404232, 2018/01/18, registered retrospectively).

Dynamic Fixation Techniques for the Prevention of Adjacent Segment Disease: A Retrospective Controlled Study

“…Even when in vitro studies clearly show that dynamic stabilization systems decrease stress loads to the adjacent level, there is no convincing evidence regarding the clinical and radiological benefits of the hybrid devices, with studies showing variable results with the topping-off technique [9,[17][18][19][20]. Putzier et al [9] reported radiological benefits of avoiding degeneration progression with dynamic instrumentation; however, they were unable to detect clinical differences in the outcome.…”

Biomechanical changes of degenerated adjacent segment and intact lumbar spine after lumbosacral topping-off surgery: a three-dimensional finite element analysis

“…However, when faced with severe clinical situation of lumbar instability, osteoporosis and severe spinal stenosis, fusion is usually needed [5,6,13,18]. The increase of movement and stress of adjacent segments after fusion is the main cause of ASDeg, moreover, for the degenerated adjacent disc, fusion may accelerate degeneration process, even result in symptomatic degeneration [19,20], especially for those with indications of fusion and moderate degeneration in the superior adjacent disc(Pfirrmann grade II-IV) [21], the fusion segments should be minimized while achieving good clinical results. As a hybrid internal fixation technique, Topping-off technique may be a fair way to solve the situation [10,22,23].…”

Biomechanical Changes of Degenerated Adjacent Segment and Intact lumbar Spine after lumbosacral Topping-off surgery: A Three-dimensional Finite Element Analysis

“…However, when faced with severe clinical situation of lumbar instability, osteoporosis and severe spinal stenosis, fusion is usually needed [5,6,13,18] . The increase of movement and stress of adjacent segments after fusion is the main cause of ASDeg, moreover, for the degenerated adjacent disc , fusion may accelerate degeneration process, even result in symptomatic degeneration [19,20] , especially for those with indications of fusion and moderate degeneration in the superior adjacent disc(Pfirrmann grade II-IV) [21] , the fusion segments should be minimized while achieving good clinical results. As a hybrid internal fixation technique, Topping-off technique may be a fair way to solve the situation [10,22,23] .…”