Group A
Group B
P
Age, years; mean(range)
68.9 (55–77)
62.8 (61–69)
n.s.
Sex
12 M, 18 F
14 M, 16 F
n.s.
Vertebral level
6 pts Th 12
16 pts L1
4 pts L2
4 pts L3
10 pts Th 12
10 pts L1
8 pts L2
2 pts L3
n.s.
Fracture type
8 pts A 3.2
22 pts A 3.3
12 pts A 3.2
18 pts A 3.3
n.s.
Table 2
Preoperative, postoperative, and follow-up clinical and radiological evaluations
Variable | Group A value – mean (range) | Group B value – mean (range) |
---|---|---|
Preoperative VAS Postoperative VAS 6-Month VAS 12-Month VAS | 7.87 (7–9) 4.27 (3–6) 1.73 (1–3) 1.40 (1–2) | 7.33 (6–9) 4.13 (2–6) 2.00 (1–3) 1.60 (1–3) |
Preoperative Cobb angle kyphosis Postoperative Cobb angle kyphosis 6-Month kyphosis angle 12-Month kyphosis angle | 20.66° (14–26) 8.93° (6–14) 7.53° (6–11) 7.53° (6–11) | 19.20° (13–28) 13.13° (4–12) 11.07° (5–11) 11.07° (5–11) |
Preoperative anterior vertebral height Postoperative anterior vertebral height 6-Month anterior vertebral height 12-Month anterior vertebral height | 17.9 mm (15–23) 24.00 mm (20–27) 23.87 mm (19–27) 23.93 mm (19–27) | 18.00 mm (14–22) 24.67 mm (22–28) 24.53 mm (22–28) 24.46 mm (22–28) |
Surgical Procedure
The surgical steps of the neuromonitoring-assisted and cement-augmented pedicle screw fixation are detailed below.
All patients underwent a single-level percutaneous cannulated PMMA cement-augmented pedicle screw fixation, using the Longitude® System (Medtronic®) (Fig. 1). After the induction of general anesthesia and before patient positioning on the surgical table, needles for neuromonitoring were placed according to the electrode placement instructions that were provided with the NIM-Eclipse System. Based on the vertebral levels to be treated, the electrical activity of the rectus abdominis, vastus lateralis, quadriceps femoris, medial gastrocnemius, and extensor hallucis longus (both sides) was monitored. Two transcranial needles were also inserted subcutaneously in the scalp, for motor evoked potential (MEP) recording. Each electrode was connected to the workstation, and baseline electromyography (EMG) was recorded. We calculated that the entire electrode positioning and connecting procedures lasted about 10 min. The patient was placed in the prone position, maintaining the physiological alignment of the spinal curves, on a radiolucent table. In this step it is crucial both to try to achieve an initial reduction of the kyphosis and to ensure that the subcutaneous needles are not displaced by the positioning maneuvers. After patient positioning, EMG recording was restarted. The comparison with the first EMG recording allowed us to detect all variations in electrical activity arising from the position on the table. Firstly, the vertebral pedicles where the percutaneous screws had to be implanted were detected with anteroposterior (AP) fluoroscopic scanning. This allowed us to mark, on the skin surface, the entry point of the percutaneous device, considering that it is preferable to use an inlet positioned laterally to the outer margins of the pedicles, to promote a convergent trajectory of the screws. A 12-mm linear skin incision was performed and the dorsolumbar fascia was sectioned. A Jamshidi needle, adequately modified, was then connected to the stimulating system and introduced through each skin incision for pedicle hole preparation (Fig. 1a). We used the needle as a pedicle probe, tracing the best and safest direction for the screw. Usually, when possible, we preferred a more lateral pedicular entry point to allow a convergent trajectory, in order to place the tips of the screws in close proximity to the median line. This seemed to improve the resistance of the implanted systems and to prevent pullout. During this phase, monitoring is useful to detect any changes in EMG activity. If EMG abnormalities are recorded, the trajectory must be modified. Subsequently a Kirschner wire (K-wire) was introduced through the needle. The K-wire reached the vertebral body and was maintained in place in order to guide the introduction of progressive tubular retractors used to facilitate the introduction of the screw. Finally, under fluoroscopic guidance, the cannulated screw was placed and the K-wire removed. Once the screw was positioned, a special ball-tip probe was inserted through the cannula, for a final test. The probe is provided with two buttons to access the functions of the workstation. The device also allows the performance of so-called screw integrity test stimulation, which combines automatic electrical stimulation and EMG response analysis to speed-test pedicle screw placement. The surgeon can control this test directly from the operative field, contacting and stimulating the screw with the probe (Fig. 1b). The test begins by stimulating at the start intensity (usually 3 mA). For each increase in stimulus intensity, the EMG response is measured and compared with default response criteria, and the response either passes or fails based on the pass/fail criteria. A stimulation threshold greater than 15 mA indicates adequate screw positioning. A good response on this test predicts the absence of electric current leakage from the bone structures and this means that the pedicle is intact. A summary of the responses of all screws tested was recorded on the workstation, then printed and stored in the clinical folder. When all the transpedicular screws had been implanted, PMMA cement was injected through the cannulated screws (Fig. 1c). We introduced about 1.5 ml of PMMA cement for each screw under fluoroscopic guidance. During cement introduction, the EMG trace was carefully monitored to promptly detect any variation arising from this procedure. The last surgical step consisted of positioning and fixing the rods. The Longitude® System provides a free-hand inserter and reduction screw extenders that are designed to allow a stabilizing rod to be passed through a small incision over the higher treated level (Fig. 1d). After the last fluoroscopic control, the rods were locked and fixed to the screws after an adequate compression, in order to guarantee reduction of the fracture and the correct alignment of the spine (Fig. 2).
Fig. 1
Surgical procedure: the combined use of surgeon-detected neuromonitoring and polymethylmethacrylate (PMMA) augmentation of the screws is shown. Firstly a modified Jamshidi needle connected with the workstation is inserted (a); after the positioning of each screw, the integrity of the pedicle is tested by introducing the probe into the cannulated screw (b). Finally, the PMMA augmentation is performed under fluoroscopic guidance (c) and the rods are inserted percutaneously with a free-hand inserter (d)
Fig. 2
Case 2, L2 fracture: preoperative (left) and postoperative (right) sagittal reconstructed computed tomography (CT) scans with comparison between preoperative and postoperative anterior vertebral height; PMMA augmentation is visible on L1 (arrow)
Results
No significant differences in age, sex, fracture site, and cause of injury were observed between the two groups (Table 1). No surgery-related complications were observed either intraoperatively or postoperatively. All operations in Group A (study group) were performed using the aforementioned technique. The average operative time ranged from 90 to 190 min. All patients were able to walk on the first day after surgery and were discharged 3 days after the surgery. Improvements in the VAS score were significant for all patients. Preoperatively, VAS scores were 7.87 and 7.33 in Group A and Group B, respectively, and these scores were significantly decreased in both groups during the follow-up period (p < 0.05) (Table 2). In the group of patients who underwent neuromonitoring, a total of 296 screws were inserted; here we observed stimulation thresholds ranging between 28 and 30 mA at the last control. In one case we observed a threshold of 11 mA, but after slightly changing of the orientation of the screw we obtained a threshold of 29 mA. Based on the method proposed by Zdichavsky et al. [24, 25], an objective evaluation of screw positioning was performed by an independent radiologist blinded to the clinical outcome. All screws used in the study group were well positioned (1a or 1b according to Zdichavsky et al.), whereas three screws in three different patients in the control group were misplaced (2b and 3b according to Zdichavsky et al.). In one case the misplaced screw was repositioned because the patient complained of sciatic pain that was related to neural conflict (Table 3). CT scans also revealed satisfactory augmentation of osteoporotic vertebral bodies, without leakage, in all patients included in the study group (Fig. 3). In contrast, one case of cement leakage was observed in the control group. The rate of complications including screw misplacement and PMMA leakage was significantly higher (p = 0.03) in the group of patients who did not receive intraoperative neuromonitoring (controls). Reduction of the kyphosis angle and restoration of the normal vertebral body height were measured and documented as reported in Table 2. Clinical and radiological follow-up was performed at 6 and 12 months, respectively. All patients underwent clinical evaluation and AP and lateral X-ray scans. The same parameters as those analyzed immediately after surgery were evaluated at follow-up, as reported in Table 2. We did not observe any adjacent segment disease or displacement of the implanted devices and cement. Satisfactory vertebral alignment was documented in all patients in the study group.
Table 3
Screw positioning: radiological evaluation according to Zdichavsky