Randomized controlled study protocol for surgical treatment of irreducible atlantoaxial dislocation

Abstract

Introduction: Irreducible atlantoaxial dislocation (IAAD) poses a complex surgical challenge, necessitating a critical evaluation of available strategies. Surgical approaches under consideration encompass the simple posterior approach and the combined anterior and posterior approach. The former offers procedural simplicity but has inherent limitations in the extent of reduction. In contrast, the latter approach holds the potential for a more comprehensive and reliable release and reduction. However, it also presents an elevated risk of infection and surgical complexity. The choice between these two strategies remains a controversy. In this article, we delineate the framework of a multicenter randomized controlled trial. Our aim is to systematically investigate the optimal surgical approach for managing IAAD, providing insights into the most efficacious and safest course of action. Methods and Analysis: Study Design: This protocol represents a collaborative effort among six medical centers. It endeavors to enroll 70 IAAD patients, stratified into two distinct trial groups: the "Simple Posterior Surgery Group" and the "Combined Anterior and Posterior Surgery Group". Primary Outcome Measures: The primary endpoints of this trial encompass a comprehensive radiological assessment and the systematic tracking of postoperative effects. Secondary Outcome Measures: In addition to the primary endpoints, this study will encompass the meticulous evaluation of specific adverse events. Additionally, we will quantify the improvement in quality of life observed within 12 months post-surgery. Ethics and Dissemination: This research endeavor has received full ethical clearance from the Peking University Third Hospital (PUTH) Medical Science Research Ethics Committee (IRB00006761-M2023203). All enrolled participants will provide informed consent voluntarily. Furthermore, it is anticipated that the findings of this study will be disseminated in a scholarly manner. The results will be submitted to a peer-reviewed journal to be published as an academically rigorous report. Trial Registration: ClinicalTrials.gov QA57. NCT05847270. 09/26/2023