Inter-observer reliability of detecting Dynesys pedicle screw using plain X-rays: a study on 50 post-operative patients

Dynamic stabilisation system for the spine (Dynesys) relies on titanium screw purchase within the pedicle. Decision on osseointegration is important especially when the patient becomes symptomatic following initial good outcome. Loose screws make the construct non-functional especially in symptomatic patients. Removal of Dynesys may become necessary to control patient's symptoms. In this study, we report interobserver reliability of X-ray for the interpretation of Dynesys pedicle screw osseointegration based on the diagnosis of "halo zone" and "Double halo zones" surrounding loose screw. Lumbar spine X-ray images of 50 patients in two views (AP and lateral) were selected from a random sample of 420 Dynesys patients. The total number of pedicle screws reviewed in this study was 260. The investigators (observers) were asked to state whether or not each pedicle screw is loose using "radiolucent zone sign". Observers were two expert orthopaedic spine consultant surgeons and one expert consultant radiologist and four specialist registrars (SpR) in orthopaedics and radiology. SpR assessments were repeated after 4 months with instructions to use "double-halo sign" for loose screws. The evaluation of interobserver agreement was performed by obtaining a Kappa (K) index. Using "radiolucent zone sign", Kappa Index (KI) among three consultants was 0.2198 at 95% CI (0.0520, 0.4916) while for all of the seven assessors (3 consultants and 4 SpR), KI was 0.1462 at 95% CI (0.0332, 0.2592). The use of "double-halo sign" was associated with KI of 0.666 at 95% CI (SE 0.83) among all of the 4 SpR. Based on plain X-ray "radiolucent zone sign", the inter-observer reliability of detecting loose Dynesys pedicle screw was poor (Kappa index of 0.2). On the other hand, using plain X-ray "double-halo sign" was associated with improved inter-observer reliability and validity.