Table 1.
Description of included clinical studies
| Study (year) | Study design (class of evidence) | Participants (spinal level) | Interventions | Accuracy assessment | Conclusions |
|---|---|---|---|---|---|
| Laine et al. [22] | Prospective comparative study (II) | 30 patients: 16 male, 14 female; age: 29–73 years Spinal stenosis, instability, painful disc degeneration, spondylolysis, pseudarthrosis, kyphosis (L1–S1) |
G1: CT Nav (139 screws) G2: convention (35 screws) |
CT | Computer-assisted surgery is superior to the conventional method |
| Merloz et al. [24] | Retrospective comparative study (III) | 64 patients: sex and age unstated Spondylolisthesis, scoliosis, fracture (T10–L5) |
G1: convention; n = 26 (52 screws) G2: CT Nav n = 26 (52 screws) G3: CT Nav n = 12 (28 screws) |
CT | Computer-assisted technique is much more accurate and safer than manual insertion |
| Laine et al. [23] | Randomized controlled trial (I) | 91 patients: sex unstated; age: 22–82 years Spinal stenosis, post-discectomy syndrome, spondylolysis/olisthesis, disc degeneration, deformity (T8–S1) |
G1: CT Nav n = 41 (219 screws) G2: convention n = 50 (277 screws) |
CT | Pedicular screws were inserted more accurately with navigation than with conventional methods |
| Amiot et al. [19] | Retrospective comparative study (III) | 150 patients: sex unstated; mean age: 48.4 years Failed back surgery, instability, tumor, spondylolisthesis, spondylodiscitis, frature, spinal stenosis (T2–S1) |
G1: convention n = 100 (544 screws) G2: CT Nav n = 50 (294 screws) |
MRI | Computer assistance decreases the incidence of incorrectly positioned pedicle screws |
| Arand et al. [27] | Prospective comparative study (II) | Population characteristics could not be detailed extracted | G1: convention (86 screws) G2: CT Nav (72 screws) |
CT | Computer-assisted freehand navigation improves results, but requires a learning curve |
| Tian et al. [38] | Retrospective comparative study (III) | 29 patients: 18 male, 11 female; age: 26–76 years Fracture, cervical spondylotic myelopathy, OPLL (cervical) |
G1: CT Nav n = 4 (24 screws) G2: convention n = 25 (150 screws) |
CT X-ray |
CT Nav has the potential of application in cervical spinal surgeries |
| Schnake et al. [28] | Retrospective comparative study (III) | 85 patients (12 undergoing two surgical techniques): 55 male, 42 female; age: 16–80 years Spondylolisthesis, tumor, fracture (T12–L5) |
G1: convention n = 41 (113 screws) G2: CT Nav n = 56 (211 screws) |
CT | CT Nav provides more accurate pedicle screw insertion than the conventional method |
| Gruetzner et al. [15] | Retrospective comparative study (III) | 113 patients: 75 male, 38 female; age: 16–76 years Injuries or degenerative changes to the spine (cervical, thoracic, lumbar) |
G1: CT Nav n = 27 (112 screws) G2: 2D FluoroNav n = 28 (108 screws) G3: 3D FluoroNav n = 24 (114 screws) G4: convention n = 34 (136 screws) |
CT | 3D fluoro Nav enhances screw insertion accuracy, and requires less fluoroscopy time compared to other approaches |
| Xu et al. [34] | Retrospective comparative study (III) | 49 patients: 29 male, 20 female; age: 42–79 years Disc herniation, spinal stenosis, spondylolisthesis, scoliosis, fracture (thoracic, lumbar) |
G1: 3D FluoroNav n = 35 (190 screws) G2: convention n = 14 (76 screws) |
3D FluoroNav | 3D FluoroNav makes pedicle screw insertion more accurate, and less time consuming |
| Richter et al. [25] | Prospective comparative study (II) | 52 patients: sex unstated; age: 29–76 years Cervical spondylotic myelopathy, fracture, tumor, implant failure, kyphotic deformity, RA, iatrogenic instabilities (cervical) |
G1: convention n = 20 (93 screws) G2: CT Nav n = 32 (167 screws) |
CT | Computer-assisted surgery system leads to significantly reduced screw misplacement |
| Seller et al. [29] | Prospective comparative study (II) | 16 patients: sex unstated; age unstated; deformity: spinal stenosis, spondylolisthesis (T12–L5) | G1: convention (24 screws) G2: CT Nav (36 screws) |
CT/MRI | Computer-assisted surgery reduces the misplacement rate of pedicle screws |
| Liu et al. [32] | Retrospective comparative study (III) | 53 patients: 33 male, 20 female; age: 23–72 years Fracture, cervical spondylotic myelopathy, deformity, OPLL, tumor (cervical) |
G1: CT Nav n = 29 (159 screws) G2: Convention n = 24 (145 screws) |
CT | CT-based navigation system increases accuracy of cervical pedicle screw fixation |
| Yang et al. [33] | Retrospective comparative study (III) | 44 patients: 26 male, 18 female; age: 15–69 years Disc herniation, spinal stenosis, spondylolisthesis, scoliosis (thoracic, lumbar) |
G1: 2D FluoroNav n = 22 (116 screws) G2: convention n = 22 (114 screws) |
X-ray | Navigation system increases the pedicle screw insertion accuracy, and decreases radiation exposure |
| Lee et al. [13] | Retrospective comparative study (III) | 60 patients: sex unstated; age: 21–91 years Cervical spondylotic myelopathy, trauma, deformity, infection, OPLL, RA, osteoporosis (C7, T1, T2) |
G1: open technique n = 32 (86 screws) G2: 2D FluoroNav n = 19 (63 screws) G3: CT Nav; n = 9 (45 screws) |
CT | Computer-assisted surgery allows for more accurate placement of pedicle screws at the CTJ |
| Lekovic et al. [14] | Retrospective comparative study (III) | 37 patients: 20 male, 17female; age: 35–81 years Trauma, degenerative disease, tumor (T1–T12) |
G1: 2D FluoroNav n = 25 (183 screws) G2: 3D FluoroNav n = 12 (94 screws) |
CT | Both image-guidance systems provide high degree of accuracy and safety |
| Merloz et al. [17] | Retrospective comparative study (III) | 52 patients: 32male; 20 female; age: 16–67 years Fracture, scoliosis, degenerative instabilities, spondylolithesis (T8–L5) |
G1: convention n = 26 (138 screws) G2: 2D FluoroNav n = 26 (140 screws) |
CT X-ray |
2D fluoro Nav for pedicle screw insertion is a reliable procedure for the lower thoracolumbar spine |
| Rajasekaran et al. [18] | Randomized controlled trial (I) | 33 patients: 10male, 23 female; age: 10–52 years Scoliosis, kyphosis (thoracic, lumbar) |
G1: convention n = 16 (236 screws) G2: 3D FluoroNav n = 17 (242 screws) |
CT | 3D fluoro Nav increases accuracy, reduces surgical time and radiation in deformity correction surgeries |
| Ito et al. [20] | Retrospective comparative study (III) | 10 patients: 1 male, 9 female; age: 29–70 years Rheumatoid arthritis (RA) (C2–C6) |
G1: CT Nav n = 5 (25 screws) G2: convention n = 5 (27 screws) |
CT | Navigation enhances pedicle screw insertion in RA patients, even if it requires more time |
| Kotani et al. [21] | Retrospective comparative study (III) | 45 patients: 8 male, 37 female; age: 6–33 years Scoliosis (thoracic, lumbar) |
G1: CT Nav n = 20 (57 screws) G2: convention n = 25 (81 screws) |
CT | Navigation system reduces the perforation rate and insertion angle errors |
| Li [31] | Retrospective comparative study (III) | 35 patients: 23 male, 12 female; age: 23–76 years Fracture, cervical spondylotic myelopathy, deformity, OPLL (cervical) |
G1: 3D FluoroNav n = 15 (75 screws) G2: convention n = 20 (76 screws) |
3D FluoroNav | 3D FluoroNav increases the accuracy of cervical pedicle screw implantation significantly |
| Yang et al. [35] | Retrospective comparative study (III) | 10 patients: 3 male, 7 female; age: 13–59 years Scoliosis (thoracic, lumbar) |
G1: CT Nav n = 5 (61 screws) G2: convention n = 5 (53 screws) |
CT radiograph |
CT Nav enhances accuracies and further improves the safety of adolescent scoliosis surgery |
| Zhang et al. [36] | Retrospective comparative study (III) | 132 patients: 63 male, 69 female; mean age: 44.8 years Disc herniation, spinal stenosis, spondylolisthesis, scoliosis, fracture (thoracic, lumbar) |
G1: 2D FluoroNav n = 66 (358 screws) G2: convention n = 66 (345 screws) |
CT X-ray |
2D FluoroNav offers more accurate pedicle screw placement than traditional operation |
| Fu et al. [12] | Retrospective comparative study (III) | 24 patients: 9 male, 15 female; age: 19–79 years Fracture, spondylolisthesis, tuberculous spondylitis, ankylosing spondylitis, revision (below T8 level) |
G1: 2D FluoroNav n = 13 (74 screws) G2: CT Nav n = 11 (76 screws) |
CT | Navigation provides accuracy for screw placement, and 2D fluoro Nav offers real-time and simple usage |
| Sakai et al. [26] | Retrospective comparative study (III) | 40 patients: 8 male, 32 female; mean age: 14.8 years Idiopathic scoliosis (thoracic, lumbar) |
G1: convention n = 20 (214 screws) G2: CT Nav n = 20 (264 screws) |
CT | Navigation system reduces the screw misplacement for rotated vertebrae |
| Nottmeier et al. [16] | Retrospective comparative study (III) | 220 patients: sex and age unstated; spinal disease unstated (T1–S1) | G1: 3D FluoroNav n = 140 (637 screws) G2: CT Nav n = 80 (314 screws) |
CT | 3D navigation improves screw insertion, and has less radiation exposure |
| Li et al. [37] | Randomized controlled trial (I) | 95 patients: 45 male, 50 female; age: 12–75 years Tumor, kyphosis, spinal stenosis, spondylolisthesis, scoliosis (spinal level unstated) |
G1: CT Nav n = 36 (206 screws) G2: convention n = 50 (285 screws) |
CT | CT Nav produces similar accuracy of screw insertion, but has prolonged operation time |
| Huang et al. [30] | Retrospective comparative study (III) | 42 patients: 29 male, 13 female; age: 24–64 years Fracture, spondylolisthesis, lumbar disc herniation (thoracic, lumbar) |
G1: 2D FluoroNav n = 21 (98 screws) G2: CT Nav n = 21 (104 screws) |
CT X-ray |
Navigation systems improve pedicle screw placing, but CT Nav needs more surgical time |
| Nakashima et al. [55] | Retrospective comparative study (III) | 67 patients: 50 male, 17 female; mean age, 52–84 years Degenerative spondylolisthesis with lumbar spinal canal stenosis |
G1: 3D FluoroNav (150 screws) G2: convention (150 screws) |
CT | It is feasible to place percutaneous posterior lumbar pedicle screws with 3D FluoroNav |