David C Noriega, Francisco Ardura, Kirollos Awad, Shefqet Hajdari, Israel Sánchez Lite, Yasser Abdalla
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引用次数: 0
Abstract
Background: Early screw loosening, a relevant complication after posterior thoracolumbar fusion, indicates high mechanical stress during rod connection. Force Control is a surgical technology that goes beyond the usual to identify, control and minimize intended and unintended, usually unnoticed forces to achieve the most stressless fixation. Optimized, extremely lightweight instruments support this principle on part of the pedicle screw system (PSS). The study objective is to evaluate the safety and efficacy of a novel PSS for Force Control fusion surgery.
Methods: In this literature-controlled observational study, patients underwent surgery with a PSS that supports Force Control. Safety is demonstrated 1 year postoperatively by non-inferiority in screw loosening rate and efficacy by non-inferiority in ODI improvement. Secondary endpoints: 2-year ODI, spine-related AEs and outcomes. Statistical significance p<0.025 (Bonferroni correction 0.05/2).
Results: 75 patients enrolled, main diagnoses were trauma (73.3%), spinal stenosis (17.3%), degenerative disc disease (6.7%). Screw loosening rate at 1-year was 2.7%, being not inferior (p=0.005) to the control group at 9.2%. Mean ODI improvement of 49.3 showed non-inferiority (p<0.001) versus 35.2 in the control group. Mean 2-year ODI was 19, mean VAS back pain improved from 80.3 to 24.1 (3-month) and 21.6 (1-year). The implant-related revision rate was 4.1%.
Conclusions: Force Control, aiming to go beyond the familiar by controlling intended and unintended forces to achieve the most stressless fixation, is a safe and efficient method. Lightweight instruments are designed to allow identifying, controlling and reducing mechanical stress. Patients benefit from Force Control regarding screw loosening and clinical outcome.
期刊介绍：
World Neurosurgery has an open access mirror journal World Neurosurgery: X, sharing the same aims and scope, editorial team, submission system and rigorous peer review.
The journal''s mission is to:
-To provide a first-class international forum and a 2-way conduit for dialogue that is relevant to neurosurgeons and providers who care for neurosurgery patients. The categories of the exchanged information include clinical and basic science, as well as global information that provide social, political, educational, economic, cultural or societal insights and knowledge that are of significance and relevance to worldwide neurosurgery patient care.
-To act as a primary intellectual catalyst for the stimulation of creativity, the creation of new knowledge, and the enhancement of quality neurosurgical care worldwide.
-To provide a forum for communication that enriches the lives of all neurosurgeons and their colleagues; and, in so doing, enriches the lives of their patients.
Topics to be addressed in World Neurosurgery include: EDUCATION, ECONOMICS, RESEARCH, POLITICS, HISTORY, CULTURE, CLINICAL SCIENCE, LABORATORY SCIENCE, TECHNOLOGY, OPERATIVE TECHNIQUES, CLINICAL IMAGES, VIDEOS
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