Accuracy and safety of percutaneous pedicle screw placement using the K-wireless minimally invasive spine percutaneous pedicle screw system in Japan: A randomized active controlled study.

Background: Minimally invasive lumbar fusion has recently become a widely used technique worldwide. This randomized active controlled study was conducted to demonstrate the non-inferiority of the K-wireless Minimally Invasive Spine (MIS) Percutaneous Pedicle Screw (PPS) system compared with use of the six pedicle screw systems currently used in our practices with respect to the accuracy of pedicle screw placement.Also to compare the screw-insertion time and number of fluoroscopic observations during screw insertion between the groups. Methods: A total of 80 patients with degenerative spinal diseases or vertebral fractures were assigned, including 41 patients in the K-wireless MIS PPS system group (K-wireless group) and 39 in the control group (K-wire group).The accuracy of the screw insertion, screw-insertion time, number of fluoroscopic observations during screw insertion, and the incidence of adverse events were compared between the K-wireless group and the K-wire group. The accuracy rate was calculated as the number of screws with no breach divided by the total number of screws. Results: The accuracy rates of screw insertion were 85.7% and 75.0% in the K-wireless and K-wire groups, respectively, with an intergroup difference of 10.7% (95% confidence interval: 2.3-19.1%). The K-wireless group demonstrated non-inferiority compared with the K-wire group. The mean screw-insertion time was significantly shorter in the K-wireless group (2.62 and 2.97 min in the K-wireless and K-wire groups, respectively; P=0.005). There were also significantly fewer fluoroscopies in the K-wireless group (10.7 and 17.4 in the K-wireless and K-wire groups, respectively; P<0.001). There were no device-related or study treatment-related adverse events in either group. Conclusions: The accuracy of pedicle screw insertion using the K-wireless MIS PPS system was not inferior to that of existing products. In terms of safety, no product-related or treatment-related adverse events were identified in this study and no new safety concerns were noted.

Psychometric Assessment of the Japanese Version of the Zurich Claudication Questionnaire (ZCQ): Reliability and Validity.

PURPOSE: The Zurich Claudication Questionnaire (ZCQ) is a self-administered measure to evaluate symptom severity, physical function, and surgery satisfaction in lumbar spinal stenosis (LSS). The purpose of this study is to assess the psychometric properties of the Japanese ZCQ in LSS patients. METHODS: LSS patients who are scheduled to undergo surgery were recruited from 12 facilities. Responses to several questionnaires, including the Japanese ZCQ; the visual analogue scale (VAS) to evaluate the degree of pain in the buttocks/legs, numbness in the buttocks/legs, and low back pain; the Oswestry Disability Index (ODI); and the SF-36v2, were collected before surgery and again 3 months after surgery (the post-surgery ZCQ was administered twice for test-retest reliability). For reliability, test-retest reliability was evaluated using the intra-class coefficient (ICC) and internal consistency was evaluated using Cronbach's alpha coefficient. Concurrent validity was assessed using Spearman's correlation coefficients between the Japanese ZCQ and other questionnaires. Effect size (ES) and standard response mean were calculated for responsiveness. All analyses were performed individually for the Japanese ZCQ symptom, function, and satisfaction domains. RESULTS: Data from 180 LSS patients were used in this analysis. The ICCs were 0.81, 0.89, and 0.88 and Cronbach's alpha coefficients were 0.78, 0.84, and 0.92 for the Japanese ZCQ symptom, function, and satisfaction domains, respectively. Regarding the concurrent validity, strong correlations (±0.5) were demonstrated between the Japanese ZCQ domains and the VAS leg pain, ODI, and SF-36v2 physical functioning or bodily pain, whereas correlations were approximately 0.3 in scales measuring other symptoms that are less related to symptom, function, or satisfaction domains. ESs showed high values for the ZCQ symptom and function domains (-1.73 for both). CONCLUSIONS: These psychometric assessments demonstrate that the Japanese ZCQ is a psychometrically reliable and valid measure in LSS. The Japanese ZCQ can evaluate both multi-dimensional aspects and the level of surgery satisfaction.

Prospective multicenter surveillance and risk factor analysis of deep surgical site infection after posterior thoracic and/or lumbar spinal surgery in adults.

BACKGROUND: Surgical site infection is a serious and significant complication after spinal surgery and is associated with high morbidity rates, high healthcare costs and poor patient outcomes. Accurate identification of risk factors is essential for developing strategies to prevent devastating infections. The purpose of this study was to identify independent risk factors for surgical site infection among posterior thoracic and/or lumbar spinal surgery in adult patients using a prospective multicenter surveillance research method. METHODS: From July 2010 to June 2012, we performed a prospective surveillance study in adult patients who had developed surgical site infection after undergoing thoracic and/or lumbar posterior spinal surgery at 11 participating hospitals. Detailed preoperative and operative patient characteristics were prospectively recorded using a standardized data collection format. Surgical site infection was based on the definition established by the Centers for Disease Control and Prevention. RESULTS: A total of 2,736 consecutive adult patients were enrolled, of which 24 (0.9%) developed postoperative deep surgical site infection. Multivariate regression analysis indicated four independent risk factors. Preoperative steroid therapy (P = 0.001), spinal trauma (P = 0.048) and gender (male) (P = 0.02) were statistically significant independent patient-related risk factors, whereas an operating time ≥3 h (P < 0.001) was a surgery-related independent risk factor. CONCLUSION: Preoperative steroid therapy, spinal trauma, male gender and an operating time ≥3 h were independent risk factors for deep surgical site infection after thoracic and/or lumbar spinal surgery in adult patients. Identification of these risk factors can be used to develop protocols aimed at decreasing the risk of surgical site infection.

Predictors of residual symptoms in lower extremities after decompression surgery on lumbar spinal stenosis.

Leg pain/numbness and gait disturbance, two major symptoms in the lower extremities of lumbar spinal stenosis (LSS), are generally expected to be alleviated by decompression surgery. However, the paucity of information available to patients before surgery about specific predictors has resulted in some of them being dissatisfied with the surgical outcome when the major symptoms remain after the procedure. This prospective, observational study sought to identify the predictors of the outcome of a decompression surgery: modified fenestration with restorative spinoplasty. Of 109 consecutive LSS patients who underwent the decompression surgery, 89 (56 males and 33 females) completed the 2 year follow-up. Both leg pain/numbness and gait disturbance determined by the Japanese Orthopedic Association scoring system were significantly improved at 2 years after surgery compared to those preoperative, regardless of potential predictors including gender, preoperative presence of resting numbness in the leg, drop foot, cauda equina syndrome, degenerative spinal deformity or myelographic filling defect, or the number of decompressed levels. However, 27 (30.3%) and 13 (14.6%) patients showed residual leg pain/numbness and gait disturbance, respectively. Among the variables examined, the preoperative resting numbness was associated with residual leg pain/numbness and gait disturbance, and the preoperative drop foot was associated with residual gait disturbance, which was confirmed by logistic regression analysis after adjustment for age and gender. This is the first study to identify specific predictors for these two remaining major symptoms of LSS after decompression surgery, and consideration could be given to including this in the informed consent.

Modified fenestration with restorative spinoplasty for lumbar spinal stenosis.

The authors developed an original procedure, modified fenestration with restorative spinoplasty (MFRS) for the treatment of lumbar spinal stenosis. The first step is to cut the spinous process in an L-shape, which is caudally reflected. This procedure allows easy access to the spinal canal, including lateral recesses, and makes it easy to perform a trumpet-style decompression of the nerve roots without violating the facet joints. After the decompression of neural tissues, the spinous process is anatomically restored (spinoplasty). The clinical outcomes at 2 years were evaluated using the Japanese Orthopaedic Association (JOA) scale and patients' satisfaction. Radiological follow-up included radiographs and CT. Between January 2000 and December 2002, 109 patients with neurogenic intermittent claudication with or without mild spondylolisthesis underwent MFRS. Of these, 101 were followed up for at least 2 years (follow-up rate 93%). The average score on the self-administered JOA scale in 89 patients without comorbidity causing gait disturbance improved from 13.3 preoperatively to 22.9 at 2 years' follow-up. Neurogenic intermittent claudication disappeared in all cases. The patients' assessment of treatment satisfaction was "satisfied" in 74 cases, "slightly satisfied" in 12, "slightly dissatisfied" in 2, and "dissatisfied" in 1 case. In 16 cases (18%), a minimum progression of slippage occurred, but no symptomatic instability or recurrent stenosis was observed. Computed tomography showed that the lateral part of the facet joints was well preserved, and the mean residual ratio was 80%. The MFRS technique produces an adequate and safe decompression of the spinal canal, even in patients with narrow and steep facet joints in whom conventional fenestration is technically demanding.