Trial reportBMC musculoskeletal disorders2018
The use of the DTO™ hybrid dynamic device: a clinical outcome- and radiological-based prospective clinical trial.
Trial report in BMC musculoskeletal disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03404232 (The Use of the DTO Hybrid Dynamic Device), which is not on this map. Cited by 8 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Use of the DTO Hybrid Dynamic Device: a Clinical Outcome- and Radiological-based Prospective Clinical Trial
Who cites it
8 citing papers in PubMed.
- Biomechanical Analysis and Mid-Term Clinical Outcomes of the Dynamic-Transitional Optima Hybrid Lumbar Device.Journal of clinical medicine · 2025Article
- The clinical efficacy of hybrid surgery based on the Waveflex semi-rigid dynamic internal fixation system for the treatment of lumbar degenerative diseases: over three-year follow-up study.BMC musculoskeletal disorders · 2025Article
- Review
- Dynamic Rod Constructs as the Preventive Strategy against Adjacent Segment Disease in Degenerative Lumbar Spinal Disorders: A Retrospective Comparative Cohort Study.The archives of bone and joint surgery · 2023Article
- Biomechanical Effect of Hybrid Dynamic Stabilization Implant on the Segmental Motion and Intradiscal Pressure in Human Lumbar Spine.Bioengineering (Basel, Switzerland) · 2022Article
- Dynamic Fixation Techniques for the Prevention of Adjacent Segment Disease: A Retrospective Controlled Study.Asian spine journal · 2022Article
- Risk of adjacent segment disease after 'topping-off' multi-level lumbar fusions with posterior dynamic stabilisers: an observational cohort study.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2021Observational
- Biomechanical changes of degenerated adjacent segment and intact lumbar spine after lumbosacral topping-off surgery: a three-dimensional finite element analysis.BMC musculoskeletal disorders · 2020Article
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
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).
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