Abstract
PURPOSE: To report the development of a new sacroiliac joint (SIJ) arthrodesis system that can be used for isolated fusion of the SIJ and, unlike known implant systems, in combination with lumbar instrumentation or as an alternative to existing sacropelvic fixation (SPF) methods, and the patient-reported outcomes in two cases. MATERIALS AND METHODS: After a comprehensive review of 207 pelvic computed tomography (CT) datasets, an implant body was designed. Its shape was modeled based on the SIJ recess. A screw anchored in the ilium secures the position of the implant and allows connection to lumbar instrumentation. Two patients with confirmed SIJ syndrome underwent surgery with the anatomically adapted implant. They were evaluated preoperatively, 6 months, and 12 months postoperatively. Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), Million Visual Analogue Scale (MVAS), Roland Morris Score (RMS), reduction of SIJ/leg pain, and work status were assessed. Bony fusion of the SIJ was evaluated by radiographs and CT 12 months after the procedure. RESULTS: Analysis of pelvic CT data revealed a wedge-shaped implant body in four different sizes. In the two patients, VAS decreased from 88 to 33 points, ODI improved from 67 to 35%, MVAS decreased from 80 to 36%, and RMS decreased from 18 to 9 points 12 months after surgery. SIJ pain reduction was 80% and 90%, respectively. Follow-up CT and radiographs showed solid bony integration. CONCLUSION: The implant used takes into account the unique anatomy of the SIJ and also meets the requirements of a true arthrodesis. Initial results in two patients are promising. Biomechanical and clinical studies will have to show whether the considerable theoretical advantages of the new implant system over existing SIJ implants - in particular the possibility of connection to a lumbar stabilization system - and SPFs can be put into practice.