Clinical study data and real-world cases show that using BoneMRI for diagnostics as well as for surgical planning and navigation provides benefits for several stakeholders, including caregivers and various patient groups.
Introduction
In our previous blog post, Performance and safety first, the importance of clinical evaluations, we highlighted the reasons why clinical evidence is needed to confirm the performance and safety of medical devices. To ensure BoneMRI is both safe and effective, multiple clinical investigations have been conducted over the years in collaboration with clinical experts. Important outcomes include for instance image accuracy and reader confidence in diagnostics as well as surgical planning and navigation. The goal? To ensure we provide accurate, reliable images that clinical experts such as radiologists and orthopedic surgeons can confidently use in their day-to-day practice.
Since the introduction of MDR 2017/745, as addressed in the previous blog post, the focus has expanded beyond pre-market studies to an emphasis on the ongoing collection of clinical data after market approval. This post-market data helps demonstrate the value of BoneMRI in real clinical use and identifies opportunities for improvement across different clinical settings.
Are you curious about the potential of BoneMRI? In this blogpost we’ll dive into the latest clinical evidence from scientific journals, and explore the exciting future of what is to come for BoneMRI.
Clinical evidence in diagnostics and surgical workflows
For BoneMRI images, also known as synthetic CT (sCT) images, to effectively support clinical workflows, they must provide accurate bone visualizations, typically assessed by comparison to conventional CT. These assessments focus on three key metrics:
- Cortical delineation error
- Tissue radiodensity error
- Tissue radiodensity contrast
In addition to accuracy, factors such as diagnostic reliability and user confidentiality are important. These qualitative metrics are generally assessed using feedback from healthcare specialists in, for example, questionnaires and/or expert readings.
The performance of BoneMRI has been studied in two clinical areas: diagnostics and surgical planning and navigation. We will dive into the findings from these activities later on.
To accurately and confidently diagnose pathologies using BoneMRI as a supporting tool, the images must be precise and high-quality, as demonstrated by both accuracy and diagnostic performance metrics. Multiple studies conducted over the last 5 years have confirmed these requirements. Below, we highlight several key studies.
Accuracy of BoneMRI imaging in pelvic and spinal areas
The accuracy of BoneMRI for the 3D morphology of the hip anatomy was investigated by several academic institutes. The University Hospital of Ghent, Belgium, performed a prospective study in 54 hips from 27 patients suspected for having inflammatory sacroiliitis [Morbée 2022]. Two experienced readers measured hip angles and joint space width to check if BoneMRI matched conventional CT. The results showed strong agreement between the two imaging methods and equivalent measurements between BoneMRI and CT within the set margins.
In another study, the performance of BoneMRI in the hip and pelvic region was assessed in adolescent patients (<21 years). Thirty-eight hips from nineteen patients were evaluated to compare equivalence, inter- and intra-rater reliability, and image quality against conventional CT. The study concluded that BoneMRI is equivalent to CT for the assessment of hip morphology, physeal status, and radiodensity in pediatric patients [Iwasaka-Neder 2023].
Synthetic CT (sCT) (top) and conventional CT (cCT) (bottom) images of the pelvis in a 14-year-old female with mild acetabular dysplasia. (Iwasaka-Neder et al, 2023)
In a separate study, BoneMRI was compared to conventional CT for assessing the bone structure of the lumbar spine in 30 patients. Two readers measured morphological parameters including pedicle and spinal canal width, vertebral body dimensions, lumbar curvature, and spinal process lengths. BoneMRI provided equal values on geometrical measurements when compared to CT. The largest difference was in disc height, which is to be expected due to different body positions on the CT and MRI tables, affecting knee posture and lumbar curve [Morbée 2021].
Van der Kolk et al. (2022) compared the quantitative metrics and image quality of BoneMRI to conventional CT for the cervical spine in patients with cervical radiculopathy. They found that BoneMRI provided optimal visualization of both soft and bony structures. Overall, BoneMRI demonstrated good image quality and strong geometric agreement with CT. These results suggest that BoneMRI could potentially be used to assess foraminal stenosis as well as conventional CT.
BoneMRI as a support in clinical diagnostics
The use of BoneMRI in axial spondyloarthritis (AxSpa)
The diagnostic performance of BoneMRI in erosions, sclerosis, and ankylosis of the sacroiliac joints (SI) was evaluated in 30 adult patients and compared to T1-weighted MRI [Jans 2020]. Using CT as the reference, the study concluded that BoneMRI outperformed routine T1-weighted MRI in identifying structural lesions in suspected sacroiliitis cases.
Willesen et al. (2024) investigated the ability of BoneMRI to detect spinal new bone formation in 17 patients with axial spondyloarthritis. The authors reported very high specificity and a higher sensitivity than radiography, despite limited reader training. This superior performance when compared to radiography indicates BoneMRI’s potential for detecting/monitoring structural spine damage in axSpA, for example, for the assessment of new pharmaceutical compounds against rheumatological disease without the use of ionising radiation. In another study with 19 patients with axSpA [Krabbe 2024] it was concluded that including BoneMRI to the MRI protocol increased sensitivity and reader confidence for the detection of erosion, sclerosis and ankylosis.
Based on the previous referenced works, we can state BoneMRI is favorable over radiography as well as conventional T1w imaging for detection of lesions in axSpa.
Adding the following work, it also shows that it can be highly valuable for incidental findings: Additional research highlighted BoneMRI’s value in identifying and evaluating incidental findings on SI joint MRI, supporting diagnostics where MRI alone is limited [Morbée 2022].
In conclusion, based on the results of the referenced scientific publications we can state BoneMRI is favorable over radiography as well as conventional T1w imaging for detection of lesions in axSpa, and has higher sensitivity for the lesions compared to conventional T1w. It was also shown that BoneMRI can be highly valuable for incidental findings.
The use of BoneMRI in fracture detection
A case report on pelvis fracture detection showed a clear visualization of bony lesions with a detailed delineation of cortical bone, indicating the potential of BoneMRI in fracture detection [Saveyn 2022].
Similarly, a recent case report described successful diagnosis and management of pediatric spondylolysis in a 14-year-old using BoneMRI which provided improved assessment of both bony and soft tissue pathology in a single study and without the ionizing radiation of traditional CT [Michael 2025]. These findings indicate a significant potential for BoneMRI, especially in adolescent patient groups.
In addition, in a prospective evaluation among 44 cervical spine fractures, BoneMRI demonstrated a 97.3% sensitivity in detecting fractures and exhibited near-perfect intermodal agreement in classifying injuries according to the AO Spine classification system, indicating comparable accuracy to CT in visualizing and classifying cervical spine injuries [Fischer 2025].
In summary, BoneMRI shows excellent accuracy in supporting diagnostics of the pelvic and spinal regions. Findings in several trials indicate that it enables the detection of conditions, such as inflammatory sacroiliitis, axSpA and fractures, that may not be visible on conventional MRI or X-ray alone. These findings highlight the potential value of BoneMRI in routine clinical MRI protocols.
BoneMRI for Surgical Planning and Navigation
BoneMRI accurately reconstructs 3D bone morphology with excellent tissue radiodensity and radiodensity contrast. As BoneMRI also comes with a DICOM CT label, BoneMRI images can be loaded in software requiring CT scans as input (CE certified, FDA pending). These features enable the use of BoneMRI images in surgical planning and navigation, potentially eliminating the need for X-ray-based imaging before or during surgery. This clinical application is of strong interest to many physicians and has been explored through multiple clinical activities, offering valuable insights into its practical use.
Staartjes et al. (2021) provided initial evidence for the use of a BoneMRI prototype in lumbar spine surgical planning and navigation in three cases. The study demonstrated accuracy and radiodensity estimation in both normal and pathological structures and planned pedicle screw trajectories and screw thickness successfully using the sCT images. This proof-of-concept was further supported by a study in which lumbosacral screws were placed using both routine CT and BoneMRI images in a cadaver. The accuracy of screw placement was comparable between the two modalities [Davidar 2023].
A midsagittal synthetic CT cut (left) in case 3 along with an axial reconstruction (right). Conventional measurements and semiautomated measurements were carried out. In addition, pedicle screw trajectories and screw thickness for both L5 pedicles were estimated on sCT imaging. (Staartjes et al, 2021)
Following these results, a prospective study involving 24 adult patients undergoing lumbar or sacral spinal stabilisation surgery for various pathologies was recently published [Rommelspacher 2025]. The authors concluded that BoneMRI provided adequate visualization of anatomical and pathological structures relevant for surgical planning, suggesting BoneMRI could serve as a valuable alternative to CT, significantly reducing radiation exposure in surgical planning and navigation.
BoneMRI is already being used in combination with the 7D Flash Navigation System. Dr. Rumley (Center for Spine and Orthopedics, Denver, USA) has highlighted BoneMRI’s usefulness in TLIF procedures.
Most recently, a case series presented at the Belgian Society of Neurosurgery congress reported on five patients whose surgical workflows were assessed for radiation exposure using CT-based versus BoneMRI-based planning using the Medtronic MAZOR™ planning equipment. The BoneMRI-based workflows resulted in a 98% reduction in radiation burden (~10 msV to 0.2 msV) compared to the CT-based workflows, which further emphasizes the potential of BoneMRI for radiation reduction [Van der Kelft E; Safety in Spine Surgery Summit; New York, 30 May 2025].
In conclusion, both published studies and real-world cases highlight the potential added value of BoneMRI for surgical planning and navigation in clinical practice. This clinical use would be very interesting to further explore, especially in combination with different navigational systems.
Populations of special interest and efficiency in the clinical workflow using BoneMRI
After establishing the accuracy and safety of BoneMRI in both healthy and pathological anatomies and applying the methodology in surgical planning and navigation, attention turned to its practical use and efficiency in the clinical workflow.
Shcherbakova et al. (2024) proposed a short MRI protocol for adolescent idiopathic scoliosis. The researchers assessed its ability to be used for detecting 3D morphology and patho-anatomical changes, screen for neural axis abnormalities, and perform preoperative planning and navigation. Based on the findings of their study involving 18 healthy volunteers, they found that the MRI protocol including BoneMRI reconstructions demonstrated high precision, reliability and inter-reader agreement for multiple scoliosis-specific measurements. They concluded that this shortened scan protocol (4 minutes for 3D sagittal T2w thoracic and cervical spine images, BoneMRI and T1w in-phase and opposed phase images) could be used to study scoliosis etiopathogenesis and in 3D spinal morphology assessment. Shortening the source image acquisition time could significantly lower the costs associated with medical imaging.
While prior research was mostly performed in adult populations, the younger population is of special interest for BoneMRI due to their higher susceptibility to the harmful effects of radiation. Therefore, expert researchers have been looking into the use of BoneMRI in adolescent populations specifically, as BoneMRI has recently been approved for use in patients aged 12 years and older. Upadhyay et al. (2023) highlighted the benefit of a reliable, radiation-free imaging method for pediatric musculoskeletal diseases, as these patients are often subject to numerous imaging evaluations, including ionizing methods such as CT. Their evaluation of BoneMRI in two adolescent patients suffering from rare bone disease (fibrous dysplasia and fibrodysplasia ossificans progressiva) indicate parallel findings between BoneMRI and traditional CT both with regards to diagnostic accuracy and radiodensity findings, indicating the potential use of BoneMRI for rare musculoskeletal disorders.
As mentioned, recently a case using BoneMRI for diagnosis of spondylolysis in a 14-year-old was published [Michael 2025]. The authors concluded that including BoneMRI in the diagnostic exam prevents missing cases of spondylolysis, potentially reducing the time to treatment in this vulnerable population. The ability to visualize both soft and osseous tissues in a single scan may support faster and more accurate diagnosis. This was further emphasized in their accompanying retrospective review of 25 pediatric spine patients, where BoneMRI demonstrated high accuracy [Illingworth, ICEOS 2024]. These case reports highlight the added value of BoneMRI in adolescent populations.