Original Title: Tecnología de cirugía de fusión vertebral guiada por imagen

Authors' objectives: To assess the scientific evidence on the safety, effectiveness and efficacy of image-guided spinal fusion surgery in patients with degenerative, infectious, metastatic, congenital and traumatic conditions of the spinal column.

Authors' results and conclusions: A total of 25 studies (5 SRs with meta-analysis and 20 cohort studies) were identified to analyse the safety and effectiveness of the techniques of interest and perform a cost-effectiveness analysis to assess their efficacy. Regarding quality, 3 of the 5 SRs were rated as high-to-moderate, 1 as moderate and 1 as moderate-to-low quality, while 1 of the 20 cohort studies was considered high quality, 6 moderate, 6 moderate-to-low and 7 low quality; the EE study shows high-to-moderate quality. 1 systematic review and 3 cohort studies indicated that performing pedicle screw fixation in spinal surgery using image-guided navigation provided better accuracy than traditional fluoroscopy techniques, while 3 cohort studies, based on small sample sizes, found no significant differences between the two techniques. Similarly, in another 3 cohort studies, pedicle screw fixation in spinal surgery using image-guided navigation techniques reduced screw malpositioning. When image-guided navigation techniques were compared to freehand surgery, the results were inconclusive in terms of accuracy, since while 1 SR indicated that the differences observed were not statistically significant, 1 cohort study found significant differences and another found a lower rate of malpositioning when image-guided navigation techniques were used, though the difference did not reach statistical significance. Regarding the rate of pedicle screw revision, implying a second surgical procedure, the results of 1 SR and a cohort study indicated that the postoperative revision rate was significantly lower when image-guided navigation rather than freehand surgical techniques had been used, the intraoperative revision rate being similar or higher with image-guided navigation. In terms of the extent, direction and level of breaches in the cortical pedicle, it was observed that image-guided navigation systems reduced both mild and severe breaches compared to freehand methods and only mild breaches compared to fluoroscopy systems; they also decreased the risk of lateral breaches compared to fluoroscopy and medial breaches compared to fluoroscopy and freehand techniques. Concerning timings, we found that surgical time was longer when pedicle screws were placed with image-guided navigation systems than with fluoroscopy systems, no differences being observed with freehand methods; placement time (between the first incision and closure of the surgical incision) was shorter with image-guided navigation than with traditional fluoroscopy; and hospital stay tended to be shorter with navigation systems than with freehand methods. Regarding radiation exposure, the results of the studies analysed indicated that radiation exposure of patients tended to be greater with image-guided navigation systems than traditional fluoroscopy. In contrast, radiation exposure of healthcare professionals, especially surgeons, tended to be lower when using image-guided navigation systems than using traditional fluoroscopy. In relation to potential complications of spinal surgery, it was observed that, although complication rates tended to be lower with image-guided navigation than methods not based on navigation (primarily traditional fluoroscopy), in intraoperative (mainly blood loss) and postoperative (mainly neurological deficit) complications, the differences were not statistically significant. Finally, the only cost-effectiveness study included indicated that the incremental cost-effectiveness ratio of the image-guided navigation technique assessed (O-arm fluoroscopy plus the StealthStation navigation system) compared to fluoroscopy guidance alone (C-arm fluoroscopy) was $15,961 (in CAD) per reoperation avoided. Assuming reoperation costs of $12,618 and the additional costs of $165,986 of purchasing an O-arm navigation system compared to the mobile C-arm system, 13.2 reoperations would need to be avoided for the O-arm navigation system to be cost neutral. With a 5.2% difference in reoperation rate, this new technology would be cost-saving if a health centre carried out more than 254 instrumented spinal procedures per year. Conclusion — Image-guided navigation systems provide greater accuracy than traditional fluoroscopy systems in pedicle screw placement in spinal surgery. — The rate of pedicle screw revision implying a second surgical procedure seems not to differ between image navigation, traditional fluoroscopy and freehand methods, although it seems that the postoperative revision rate is lower with image-guided navigation systems than with fluoroscopy. — Navigation systems require more time for setting up the operating theatre and planning the trajectory of the screws. — Navigation techniques are associated with a shorter lower screw insertion time than traditional fluoroscopy, reducing the time required to complete the surgery itself and patients’ radiation exposure. Further, hospital stay tends to be shorter with navigation systems than freehand methods. — Radiation exposure of patients tends to be higher with image-guided navigation systems than with traditional fluoroscopy, while that of surgeons seems to be lower with the navigation systems than with traditional fluoroscopy. — The rates of intraoperative (mainly blood loss) and postoperative (mainly neurological deficit) complications associated with spinal surgery for pedicle screw fixation seem to be lower with image-guided navigation than with systems not based on this approach (in particular, traditional fluoroscopy), although differences did not reach statistical significance. — From an economic point of view, evidence suggests that the high costs of purchasing and maintaining image-guided navigation equipment can be compensated for by reductions in reoperation rates associated with greater accuracy.

Authors' methods: The study was based on a structured search in general and specific databases of scientific literature (Medline [through PubMed], Embase [through OVID], Cochrane Library and CINAHL [through EBSCOHost]) and economic evaluation (NHS Economic Evaluation Database). The search strategy, implemented in October 2019, was based on a report provided by the ECRI Institute. The search included systematic reviews (SRs) with or without meta-analysis, clinical trials, case-control studies, cohort studies, and full economic evaluations (EEs) and cost studies assessing 3D image-guided systems using fluoroscopy or intraoperative CT with navigation against freehand imaging techniques, computed-guided 2D fluoroscopy, or intraoperative 3D fluoroscopy, in patients with degenerative, infectious, metastatic, congenital or traumatic spinal conditions, undergoing spinal fusion surgery involving pedicle screw fixation. Two reviewers independently selected the studies after reading titles and abstracts. Those considered relevant were independently analysed. Disagreements were resolved by discussion. The critical appraisal tool FLC 3.0 (Basque Office for Health Technology Assessment, OSTEBA) was used to assess the quality of the studies selected.

Project Status: Completed

Year Published: 2022

URL for published report: https://www.euskadi.eus/contenidos/informacion/osteba_publicacion/eu_def/adjuntos/01_Osteba_Tecnologia_cirugia_fusionvertebral.pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government</p>