Trial reportBMC surgery2026
Clinical application research of navigation system-assisted vertebroplasty for the treatment of lumbar osteoporotic compression fractures.
Trial report in BMC surgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectiveThis study aims to compare the clinical efficacy and radiological outcomes of the computer navigation-assisted system versus traditional fluoroscopy-assisted percutaneous vertebroplasty (PVP) in the treatment of lumbar osteoporotic vertebral compression fractures (OVCFs). The goal is to clarify the advantages and disadvantages of the computer navigation system in assisting PVP surgery, thereby providing references and experience for the promotion and application of this technology in minimally invasive spinal surgeries.
methodsThis study is a single-center, prospective, randomized controlled trial. Patients who underwent lumbar percutaneous vertebroplasty (PVP) for the treatment of lumbar osteoporotic vertebral compression fracture (OVCF) at General Hospital of Northern Theater Command from January 2023 to January 2024 were included. Cases that met the inclusion and exclusion criteria were randomly divided into two groups using a random number table method: the computer navigation-assisted PVP group (navigation group) and the traditional fluoroscopy-assisted PVP group (traditional group), with allocation concealment implemented. The following data were recorded for both groups: basic baseline characteristics of the patients; the number and duration of needle punctures, total number and duration of fluoroscopy, and total surgical time; the amount of bone cement used, and the incidence of complications (bone cement leakage rate, nerve injury, vascular injury, and vascular embolism); preoperative and postoperative Visual Analogue Scale (VAS) scores and Oswestry Disability Index (ODI) scores, as well as the mean height of fractured vertebrae (HFV). Follow-up was conducted at 3, 6, and 12 months postoperatively for both groups of patients.
resultsThis study recruited 68 patients with lumbar osteoporotic vertebral compression fracture (OVCF) who underwent percutaneous vertebroplasty (PVP) from January 2023 to January 2024. Cases that met the inclusion and exclusion criteria were randomly divided into two groups using a random number table method: the computer navigation-assisted PVP group (navigation group, 35 cases) and the traditional fluoroscopy-assisted PVP group (traditional group, 33 cases), with allocation concealment implemented. In the navigation group, 3 patients were lost to follow-up (loss rate of 8.57%), and in the traditional group, 3 patients were lost to follow-up (loss rate of 9.09%). Finally, the navigation group included 32 cases, and the traditional group included 30 cases. There were no significant differences between the two groups in terms of age, preoperative T-score, and preoperative Visual Analogue Scale (VAS) scores (P > 0.05), indicating comparability. The VAS scores of patients in the navigation group were lower than those in the traditional group when puncturing to the target site. The total number of fluoroscopies in the navigation group was lower than that in the traditional group. The total fluoroscopy time in the navigation group was less than that in the traditional group. The amount of bone cement used in the navigation group was higher than that in the traditional group. The number of bone cement leakage cases in the navigation group was lower than that in the traditional group (P < 0.05). The number of punctures in the navigation group was significantly lower than that in the traditional group, and the puncture time in the navigation group was significantly shorter than that in the traditional group (P < 0.001). No significant vascular injury, nerve injury, or vascular embolism occurred in either group. There were no significant differences in postoperative VAS and ODI scores or in the recovery of the mean height of fractured vertebrae (HFV) between the two groups (P > 0.05).
conclusionThe computer-assisted navigation systems in PVP can improve the accuracy of needle puncture and surgical safety, reduce the number of fluoroscopic exposures, shorten fluoroscopy time, and decrease radiation exposure for both patients and medical staff during the procedure. This enhances the procedural experience for patients and achieves “visualization of surgical operations”, thereby realizing the goal of “precision medicine”.
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