Evaluation of the efficacy and safety of 3D printing porous titanium cage with non-window type versus window type in posterior lumbar interbody fusion: A prospective, randomized, multicenter trial study

Abstract

Trials guidance: The Abstract should not exceed 350 words. Please minimize the use of abbreviations and do not cite references in the abstract. The abstract must include the following separate sections: • Background: No studies have compared the clinical outcome and radiographic outcome between window and non-window three-dimensional titanium (3D-Ti) cages. Therefore, well designed a randomized controlled trial (RCT) is needed. This multicenter, prospective RCT will compare the outcomes of window and non-window 3D-Ti cage in lumbar interbody fusion surgery. • Methods: Study participants will be randomly assigned to the active intervention group or control intervention group in a 1:1 ratio and undergone a one-level posterior lumbar interbody fusion (PLIF) for degenerative lumbar disease. The window type 3D-Ti cage will be used in the participants assigned to the control intervention group. And the non-window type 3D-Ti cage will be used in the participants assigned to the active intervention. The clinical and radiographic outcomes between two groups will be compared serially until postoperative 12-months. • Discussion: This trial designated for evaluating the equivalence of the clinical outcome between window and non-window 3D-Ti cage and will provide data on the effectiveness and safety of non-window type 3D-Ti cage. • Trial registration: Clinical Research Information Service (cris.nih.go.kr) (KCT 0005793). Registered on 19 January 2021