The study was approved by the Ethics Committee of the Second Hospital of Lanzhou University (Approval no. 2025A-1064) and was conducted in accordance with institutional requirements for research involving human participants. All participants, or their legally authorized representatives, provided written informed consent for research participation, follow-up data collection, and publication of de-identified clinical images. The tools used for this protocol are listed in the Table of Materials.
1. Study design, setting, and participants
This single-center randomized controlled trial enrolled patients treated at the Second Hospital of Lanzhou University from October 2025 to March 2026. Eligible patients were randomly allocated to the smartphone measurement application group (n = 21) or the conventional localization group (n = 22). All procedures in both groups were performed by the same senior spine surgeon to reduce between-operator procedural variability.
Patients were eligible for inclusion if they had an acute thoracolumbar osteoporotic vertebral compression fracture involving T10–L2 that was confirmed by clinical examination, radiography, and preoperative imaging; a symptom duration of < 3 months; low-back pain corresponding to the fractured level; a Visual Analog Scale score > 4; an inadequate response to conservative treatment; a bone mineral density T-score of ≤−2.5 measured by dual-energy X-ray absorptiometry (DXA), consistent with osteoporosis; an absolute or relative indication for percutaneous vertebroplasty (PVP); and written informed consent provided by the patient or a legally authorized representative.
Patients were excluded if they had a pathological fracture caused by malignancy, multiple myeloma, infection, or another defined cause; disruption of the posterior vertebral wall; pedicle fracture; retropulsion into the spinal canal with spinal cord or nerve-root compression; burst fracture; vertebral collapse > 75%; severe cardiopulmonary, neurological, hepatic, renal, or coagulation disorders; previous spinal surgery at the same or an adjacent level; severe cognitive or psychiatric impairment preventing completion of perioperative assessment or follow-up; allergy to a contrast agent used during surgery; or pregnancy or lactation.
2. Randomization and allocation
A random sequence was generated from a random-number table by a clinician from another department who was not involved in the study. Eligible patients were allocated in a 1:1 ratio to either the smartphone measurement application group or the conventional localization group. Allocation concealment was maintained using sealed, opaque, consecutively numbered envelopes. Each envelope containing the group assignment was opened by the circulating nurse in the operating room only after written informed consent had been obtained. Because the localization procedures were visibly different, the operating surgeon could not be blinded to group assignment.
3. Smartphone measurement application calibration and operator training
A single depth-sensing smartphone and a single operating system version were used for each patient in the smartphone measurement application group. Calibration of the smartphone measurement application was required before each clinical measurement.
The calibration procedure was performed as follows. First, a standard 20 cm physical ruler was used as the reference distance. Second, calibration was performed indoors under stable lighting and room-temperature conditions to reduce environmental variability. Third, a single well-trained operator placed the smartphone at the ruler origin and moved it to the 20 cm mark, and the value reported by the measurement application was recorded. This sequence was repeated at least twice before each clinical measurement to ensure repeatability.
Measurements were accepted only when the discrepancy between the application reading and the physical ruler was < 5 mm. Representative repeated calibration measurements are shown in Figure 1.
Screen brightness and autofocus settings were maintained throughout all calibration and clinical sessions to minimize variation caused by ambient illumination. Standardized training covered application use, scanning-plane selection, maintenance of device orientation, distance transfer, and endpoint marking.

Figure 1: Preoperative calibration of the smartphone measurement application. (A, B) Two repeated measurements of a 20 cm physical ruler were performed under stable indoor conditions. Both displayed measurements were 20 cm. Clinical use required a discrepancy of < 5 mm. Please click here to view a larger version of this figure.
4. Preoperative imaging measurement
Preoperative sagittal computed tomography (CT) reconstructions were reviewed using a medical imaging archiving and communication system. The midsagittal image showing the full length of the sacrum was identified first. The image series was then advanced laterally until the sacrum narrowed and the posterior ilium appeared (Figure 2).
The posterior superior iliac spine was identified where the posterior ilium intersected or separated from the sacrum. The vertical distance from the posterior superior iliac spine to the spinous process at the fractured vertebral level was then measured. In the representative case shown in Figure 3, the displayed distance was 190.43 mm.

Figure 2: Preoperative sagittal computed tomography reconstruction used to identify the fractured thoracolumbar vertebral level and define the measurement plane. The green dots indicate the posterior superior iliac spine. Patient identifiers and institutional metadata have been removed. Please click here to view a larger version of this figure.

Figure 3: Preoperative sagittal computed tomography reconstruction showing measurement of the vertical distance from the posterior superior iliac spine reference level to the fractured vertebral level. The displayed distance was 190.43 mm. The green line represents the distance measured on the preoperative picture archiving and communication system from the posterior superior iliac spine to the spinous process at the fractured level. Patient identifiers and institutional metadata have been removed. Please click here to view a larger version of this figure.
5. Smartphone measurement application for body-surface localization
Before localization, the smartphone case and camera lens were cleaned with alcohol wipes. The patient was placed prone in a neutral position on the spinal operating table. The posterior superior iliac spine nearest the surgeon was palpated and marked (Figure 4).
The smartphone screen was positioned facing the surgeon, the measurement origin was placed at the marked posterior superior iliac spine, and the smartphone's long axis was maintained parallel to the patient’s back. The smartphone was moved slowly toward the head in the coronal plane while large horizontal fluctuations were avoided (Figure 5).
When the displayed distance corresponded to the preoperative imaging measurement, the endpoint was marked on the skin. Using this endpoint as a landmark, the presumed spinous process at the level of fracture was identified. A syringe needle was placed adjacent to the spinous process as a radiopaque marker (Figure 6).
Lateral fluoroscopy was then performed to verify the vertebral level before PVP (Figure 7). The smartphone served only as an auxiliary localization tool and did not replace fluoroscopic confirmation.

Figure 4: Intraoperative marking of the posterior superior iliac spine. The yellow marker indicates the palpated landmark. The left side of the image is oriented toward the patient’s head, and the right side is oriented toward the patient’s feet. Please click here to view a larger version of this figure.

Figure 5: Transfer of the preoperative distance to the patient’s back using the smartphone measurement application. The application displays a transfer distance of 19 cm, and the yellow dots indicate the endpoint of the transfer. The left side of the image is oriented toward the patient’s head, and the right side is oriented toward the patient’s feet. Please click here to view a larger version of this figure.

Figure 6: Placement of a radiopaque marker adjacent to the presumed T12 spinous process. The red marker denotes the presumed fractured segment, and the yellow marker denotes the reference point corresponding to the transferred endpoint. A 10 mL syringe needle was placed adjacent to the fractured segment for fluoroscopic verification. Please click here to view a larger version of this figure.

Figure 7: Anonymized lateral C-arm fluoroscopic confirmation of the marked T12 level. The red line indicates the position of the radiopaque marker, represented by a 10 mL syringe needle. Institutional names, patient identifiers, dates, and procedural metadata have been removed. Please click here to view a larger version of this figure.
6. Conventional localization
In the conventional localization group, the same surgeon estimated the target vertebral level using the posterior superior iliac spine, palpable spinous processes, interspinous spaces, and clinical experience. The estimated site was marked on the skin and checked using lateral fluoroscopy.
When the mark did not correspond to the intended vertebral level, the mark was adjusted and fluoroscopy was repeated until the correct level was confirmed.
7. Outcomes and time recording
T0, defined as localization time, was measured from the start of intraoperative localization, when the surgeon began marking the skin, until completion of anteroposterior and lateral fluoroscopy confirming the fractured vertebral level.
In the smartphone measurement application group, T0 included palpation of the posterior superior iliac spine and initiation of the smartphone measurement application. In the conventional localization group, T0 began with freehand marking based on anatomical landmarks.
T1, defined as correction time, represented the additional time required for remarking and repeated fluoroscopic verification when the initial skin marker did not overlie the fractured vertebral body. T1 was recorded as 0 when the initial localization was accurate.
T0, T1, and the number of fluoroscopic images were recorded prospectively by a circulating operating room nurse who was not involved in the surgical procedure. A standard stopwatch and data-collection sheet were used.
Clinical outcomes included Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) scores obtained before surgery and at 3 months. The number of fluoroscopic images was recorded only during the localization phase. Only the number of fluoroscopic images obtained to locate the fractured vertebral level was recorded; fluoroscopy time and actual radiation dose were not collected.
8. Statistical analysis
Statistical analyses were performed using statistical analysis software. Approximately normally distributed continuous variables were summarized as mean ± standard deviation, and non-normally distributed variables were summarized as median and interquartile range.
Between-group continuous variables were compared using independent-samples t-tests or Mann–Whitney U tests, as appropriate. Categorical variables were reported as n (%) and compared using the chi-square test or Fisher’s exact test when expected cell counts were small. All tests were two-sided, and P < 0.05 was considered statistically significant.