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José Miguel Spirig, Shayan Golshani, Nadja A. Farshad-Amacker, and Mazda Farshad

OBJECTIVE

Patient-specific template-guided (TG) pedicle screw placement currently achieves the highest reported accuracy in cadaveric and early clinical studies, with reports of reduced use of radiation and less surgical time. However, a clinical randomized controlled trial (RCT) eliminating potential biases is lacking. This study compares TG and standard freehand (FH) pedicle screw insertion techniques in an RCT.

METHODS

Twenty-four patients (mean age 64 years, 9 men and 15 women) scheduled consecutively and independently from this study for 1-, 2-, or 3-level lumbar fusion were randomized to either the FH (n = 12) or TG (n = 12) group. Accuracy of pedicle screw placement, intraoperative parameters, and short-term complications were compared.

RESULTS

A total of 112 screws (58 FH and 54 TG screws) were implanted in the lumbar spine. Radiation exposure was significantly less in the TG group (78.0 ± 46.3 cGycm2) compared with the FH group (234.1 ± 138.1 cGycm2, p = 0.001). There were 4 pedicle screw perforations (6.9%) in the FH group and 2 (3.7%) in the TG group (p > 0.99), with no clinical consequences. Clinically relevant complications were 1 postoperative pedicle fracture in the FH group (p > 0.99), 1 infection in the FH group, and 2 infections in the TG group (p > 0.99). There were no significant differences in surgical exposure time, screw insertion time, overall surgical time, or blood loss between the FH and TG groups.

CONCLUSIONS

In this RCT, patient-specific TG pedicle screw insertion in the lumbar region achieved a high accuracy, but not better than a standardized FH technique. Even if intraoperative radiation exposure is less with the TG technique, the need for a preoperative CT scan counterbalances this advantage. However, more difficult trajectories might reveal potential benefits of the TG technique and need further research.

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Ulrike Held, Johann Steurer, Giuseppe Pichierri, Maria M. Wertli, Mazda Farshad, Florian Brunner, Roman Guggenberger, François Porchet, Tamás F. Fekete, Urs D. Schmid, Isaac Gravestock, and Jakob M. Burgstaller

OBJECTIVE

The aim of this study was to obtain an unbiased causal treatment estimate of the between-group difference of surgery versus nonoperative treatment with respect to outcomes on quality of life, pain, and disability in patients with degenerative lumbar spinal stenosis (DLSS) 12 months after baseline.

METHODS

The authors included DLSS patients from a large prospective multicenter observational cohort study. Propensity score matching was used, including 15 demographic, clinical, and MRI variables. Linear and logistic mixed-effects regression models were applied to quantify the between-group treatment effect. Unmeasured confounding was addressed in a sensitivity analysis, assessing the robustness of the results.

RESULTS

A total of 408 patients were included in this study, 222 patients after matching, with 111 in each treatment group. Patients with nonoperative treatment had lower quality of life at the 12-month follow-up (−6.21 points, 95% CI −9.93 to −2.49) as well as lower chances of reaching a minimal clinically important difference in Spinal Stenosis Measure (SSM) symptoms (OR 0.26, 95% CI 0.13 to 0.53) and SSM function (OR 0.26, 95% CI 0.14 to 0.49), than patients undergoing surgery. These results were very robust in case of unmeasured confounding. The surgical complication rate was low; 5 (4.5%) patients experienced a durotomy during intervention, and 5 (4.5%) patients underwent re-decompression.

CONCLUSIONS

The authors used propensity score matching to assess the difference in treatment efficacy of surgery compared with nonoperative treatment in elderly patients with DLSS. This study delivers strong evidence that surgical treatment is superior to nonoperative treatment. It helps in clinical decision-making, especially when patients suffer for a long time, sometimes over many years, hoping for a spontaneous improvement of their symptoms. In light of these new results, the number of years with disability can hopefully be reduced by providing adequate treatment at the right time for this ever-growing elderly and frail population.

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Nils H. Ulrich, Jakob M. Burgstaller, Isaac Gravestock, Giuseppe Pichierri, Maria M. Wertli, Johann Steurer, Mazda Farshad, and François Porchet

OBJECTIVE

In this retrospective analysis of a prospective multicenter cohort study, the authors assessed which surgical approach, 1) the unilateral laminotomy with bilateral spinal canal decompression (ULBD; also called “over the top”) or 2) the standard open bilateral decompression (SOBD), achieves better clinical outcomes in the long-term follow-up. The optimal surgical approach (ULBD vs SOBD) to treat lumbar spinal stenosis remains controversial.

METHODS

The main outcomes of this study were changes in a spinal stenosis measure (SSM) symptoms score, SSM function score, and quality of life (sum score of the 3-level version of the EQ-5D tool [EQ-5D-3L]) over time. These outcome parameters were measured at baseline and at 12-, 24-, and 36-month follow-ups. To obtain an unbiased result on the effect of ULBD compared to SOBD the authors used matching techniques relying on propensity scores. The latter were calculated based on a logistic regression model including relevant confounders. Additional outcomes of interest were raw changes in main outcomes and in the Roland and Morris Disability Questionnaire from baseline to 12, 24, and 36 months.

RESULTS

For this study, 277 patients met the inclusion criteria. One hundred forty-nine patients were treated by ULBD, and 128 were treated by SOBD. After propensity score matching, 128 patients were left in each group. In the matched cohort, the mean (95% CI) estimated differences between ULBD and SOBD for change in SSM symptoms score from baseline to 12 months were −0.04 (−0.25 to 0.17), to 24 months −0.07 (−0.29 to 0.15), and to 36 months −0.04 (−0.28 to 0.21). For change in SSM function score, the estimated differences from baseline to 12 months were 0.06 (−0.08 to 0.21), to 24 months 0.08 (−0.07 to 0.22), and to 36 months 0.01 (−0.16 to 0.17). Differences in changes between groups in EQ-5D-3L sum scores were estimated to be −0.32 (−4.04 to 3.40), −0.89 (−4.76 to 2.98), and −2.71 (−7.16 to 1.74) from baseline to 12, 24, and 36 months, respectively. None of the group differences between ULBD and SOBD were statistically significant.

CONCLUSIONS

Both surgical techniques, ULBD and SOBD, may provide effective treatment options for DLSS patients. The authors further determined that the patient outcome results for the technically more challenging ULBD seem not to be superior to those for the SOBD even after 3 years of follow-up.