Monitoring the quality of robot-assisted pedicle screw fixation in the lumbar spine by using a cumulative summation test.

STUDY DESIGN: Prospective randomized controlled trial. OBJECTIVE: The aim of this study was to monitor the quality control of robot-assisted pedicle screw fixation accuracy by using a cumulative summation (CUSUM) test at the initial stage of its application. SUMMARY OF BACKGROUND DATA: Although robot-assisted pedicle screw fixation reduces screw misplacement rates and provides critical support for minimally invasive surgical procedures, there have been no reports relating to the monitoring of quality control of the accuracy of this robot-assisted pedicle screw fixation procedure. METHODS: Patients with lumbar spinal stenosis scheduled to undergo surgery were randomly and equally assigned through 1:1 allocation to a robot-assisted minimally invasive posterior lumbar interbody fusion (Rom-PLIF) group or a conventional open posterior PLIF using freehand technique group. The accuracy of pedicle screw placement was evaluated using postoperative computed tomography. The primary outcome was the CUSUM analysis for monitoring the quality control of the accuracy of pedicle screw insertion between the Rom-PLIF and conventional open posterior PLIF using freehand technique groups. RESULTS: Of the 80 pedicle screws inserted in each group, 4 screws in the Rom-PLIF group, and 7 in the conventional open PLIF group, breached the pedicle. Of these 11 offending screws, 4 cases were categorized as grade B in the Rom-PLIF group, whereas 6 were grade B and 1 case was grade C in the Com-PLIF group, using the Gertzbein and Robbins classification. Throughout the monitoring period, there was no CUSUM test-derived indication that the quality of performance of the pedicle screw fixation procedure was inadequate in either group. CONCLUSION: First, this study demonstrates the adequacy of quality control of robot-assisted pedicle screw fixation even early in the application period based on the CUSUM analysis. Second, the CUSUM test can be a useful tool for monitoring of the quality of procedures related with spine surgery.

Comparative study of the treatment outcomes of osteoporotic compression fractures without neurologic injury using a rigid brace, a soft brace, and no brace: a prospective randomized controlled non-inferiority trial.

BACKGROUND: The efficacy of brace application for the treatment of osteoporotic compression fractures remains unclear. The purpose of this study was to compare the treatment outcomes in patients with osteoporotic compression fractures with regard to whether the patients had no braces, rigid braces, or soft braces. METHODS: We randomly assigned sixty patients with acute one-level osteoporotic compression fractures within three days of injury to the no-brace, soft-brace, and rigid-brace groups through 1:1:1 allocation. The primary outcome was the baseline adjusted Oswestry Disability Index score at twelve weeks after compression fracture. The non-inferior margin of the Oswestry Disability Index was set at an average of 10 points. RESULTS: The baseline adjusted Oswestry Disability Index score at twelve weeks after compression fracture in the no-brace group was not inferior to that in the soft-brace or rigid-brace groups. The mean adjusted Oswestry Disability Index score was 35.95 points (95% confidence interval, 25.42 to 46.47 points) in the no-brace group and 37.83 points (95% confidence interval, 26.77 to 48.90 points) in the soft-brace group, with a difference of -1.88 points (95% confidence interval, -7.02 to 9.38 points) between the groups. Similarly, the mean adjusted Oswestry Disability Index score was 35.95 points (95% confidence interval, 25.42 to 46.47 points) in the no-brace group and 33.54 points (95% confidence interval, 23.79 to 43.29 points) in the rigid-brace group, with a difference of 2.41 points (95% confidence interval, -7.86 to 9.27 points) between the groups. During the follow-up assessment period, there was no significant difference among the groups for the overall Oswestry Disability Index scores (p = 0.260), visual analog scale for pain scores for back pain (p = 0.292), and anterior body compression ratios (p = 0.237). However, the Oswestry Disability Index scores and the visual analog scale scores for back pain significantly improved with time after the fractures (p < 0.001), and the body compression ratios significantly decreased with time in all three groups (p < 0.001). CONCLUSIONS: The Oswestry Disability Index scores for the treatment of compression fractures without a brace were not inferior to those with soft or rigid braces. Moreover, the improvement in back pain and progression of anterior body compression were similar among the three groups. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Translation, cross-cultural adaptation, and validity of the Korean version of the pain sensitivity questionnaire in chronic pain patients.

The purpose of this study was to translate pain sensitivity questionnaires (PSQ) into the Korean language, perform a cross-cultural adaption of the PSQ, and validate the Korean version of PSQ in patients with degenerative spinal disease. The PSQ was translated forward and backward, cross-culturally adapted by 2 independent translators, and approved by an expert committee. The final Korean version of the PSQ was tested on 72 patients with degenerative spinal disease. Test-retest reliability was evaluated for 60 patients (83%) who completed the second assessment in an interval of 4 weeks. The mean PSQ-minor, PSQ-moderate, and PSQ-total (standard deviation [SD]) were 5.40 (2.02), 6.46 (1.98), and 5.93 (1.93), respectively. The PSQ-total, PSQ-minor, and PSQ-moderate of the Korean version showed very good internal consistencies determined by the Cronbach's α of 0.926, 0.869, and 0.877, respectively. For convergent validity, the PSQ scores of the Korean version showed significant correlations with pain catastrophizing scale (PCS) (r = 0.377, P = 0.002; r = 0.365, P = 0.003; r = 0.362, P = 0.003 for PSQ-total, PSQ-minor, and PSQ-moderate of the Korean version, respectively). For test-retest reliability, the intraclass correlation coefficients were 0.782 for PSQ-total, 0.752 for PSQ-minor, and 0.793 for PSQ-moderate. In conclusion, the validated Korean version of PSQ is a transculturally equivalent, reliable, and valid tool to assess individual pain sensitivity.

Treatment of Intertrochanteric Fractures Using the Compression Hip Nail.

PURPOSE: To investigate the clinical and radiologic outcomes following treatment of intertrochanteric fractures using the Compression Hip Nail® (CHN), which has a sliding lag screw. MATERIALS AND METHODS: Twenty-eight cases of intertrochanteric fractures treated with CHN from November 2012 to October 2013 and followed-up for >6 months were included. The patient population consisted of 11 men and 17 women with a mean age of 75.2 years at the time of surgery. For the initial 11 cases, 10 mm sliding lag screws were used; the remaining 17 cases used 20 mm sliding lag screws. Clinical variables including operation time, amount of transfusion, weight-bearing start time, postoperative physical activity, and complications were investigated. The average sliding of lag screws and the average union were investigated radiologically at 3 and 6 months after surgery. RESULTS: In an analysis of 23 cases (exclusion of 3 cases of lag screw cutout and 2 cases of nonunion), 11 (48%) recovered their pre-injury activity level. In an analysis of 25 cases (exclusion of 3 cases of cutout), 17 (68%) and 23 (92%) showed radiological union at postoperative months 3 and 6, respectively. Seven complications were noted. Cutout of the lag screw and the lateral protrusion of barrels were significantly greater in the group with 10 mm sliding lag screws as compared to the group using 20 mm sliding lag screws. CONCLUSION: The use of CHN for the treatment of intertrochanteric fracture yielded poor results. However, results from patients in the 20 mm sliding lag screw group were better than for the 10 mm sliding lag screw group. Therefore, use of the 20 mm sliding lag screw is advisable.