Validation of a surgical invasiveness index in patients with lumbar spinal disorders registered in the Spine Tango registry.

INTRODUCTION: Being able to quantify the invasiveness of a surgical procedure is important to weigh up its associated risks, since invasiveness governs the blood loss, operative time and likelihood of complications. Mirza et al. (Spine (Phila Pa 1976) 33:2651-2661, 2008) published an invasiveness index for spinal surgery. We evaluated the validity of a modified version of the Mirza invasiveness index (mMII), adapted for use with registry data. METHODS: A cross-sectional analysis was performed with data acquired from the Spine Tango registry including 21,634 patients. The mMII was calculated as the sum of six possible interventions on each vertebral level: decompression, fusion and stabilization either on anterior or posterior structures. The association between the mMII and blood loss, operative time and complications was evaluated using multiple regression, adjusting for possible confounders. RESULTS: The mean (± SD) mMII was 3.9 ± 5.0 (range 0-40). A 1-point increase in the mMII was associated with an additional blood loss of 12.8% (95% CI 12.6-13.0; p < 0.001) and an increase of operative time of 10.4 min (95% CI 10.20-10.53; p < 0.001). The R2 for the blood loss model was of 43% and for operative time, 47%. The mean mMII was significantly (p < 0.001) higher in patients with surgical complications (4.5 ± 5.6) and general medical complications (6.5 ± 7.0) compared to those without (3.8 ± 4.9). Our results were comparable to those reported in the original publication of Mirza et al. CONCLUSION: The mMII appeared to be a valid measure of surgical invasiveness in our study population. It can be used in predictor models and to adjust for surgical case-mix when comparing outcomes in different studies or different hospitals/surgeons in a registry.

Development and temporal validation of a prognostic model for 1-year clinical outcome after decompression surgery for lumbar disc herniation.

PURPOSE: Surgeons need tools to provide individualised estimates of surgical outcomes and the uncertainty surrounding these, to convey realistic expectations to the patient. This study developed and validated prognostic models for patients undergoing surgical treatment of lumbar disc herniation, to predict outcomes 1 year after surgery, and implemented these models in an online prediction tool. METHODS: Using the data of 1244 patients from a large spine unit, LASSO and linear regression models were fitted with 90% upper prediction limits, to predict scores on the Core Outcome Measures Index, and back and leg pain. Candidate predictors included sociodemographic factors, baseline symptoms, medical history, and surgeon characteristics. Temporal validation was conducted on 364 more recent patients at the same unit, by examining the proportion of observed outcomes exceeding the threshold of the 90% upper prediction limit (UPL), and by calculating mean bias and other calibration measures. RESULTS: Poorer outcome was predicted by obesity, previous spine surgery, and having basic obligatory (rather than private) insurance. In the validation data, fewer than 12% of outcomes were above the 90% UPL. Calibration plots for the model validation showed values for mean bias < 0.5 score points and regression slopes close to 1. CONCLUSION: While the model accuracy was good overall, the prediction intervals indicated considerable predictive uncertainty on the individual level. Implementation studies will assess the clinical usefulness of the online tool. Updating the models with additional predictors may improve the accuracy and precision of outcome predictions. These slides can be retrieved under Electronic Supplementary Material.

Correction to: Patient and surgical characteristics that affect revision risk in dynamic intraligamentary stabilization of the anterior cruciate ligament.

The original version of this article unfortunately contained a mistake.

Predictors for secondary hip osteoarthritis after acetabular fractures-a pelvic registry study.

PURPOSE: Secondary hip osteoarthritis after acetabular fractures requiring total arthroplasty (THA) poses a huge burden on the affected patients as well as health systems. The present study aimed to assess risk factors associated with THA after acetabular fractures based on the data from the German Pelvic Trauma Registry. METHODS: Retrospective analysis of 678 acetabular fracture cases without concomitant pelvic ring fracture treated and followed-up between January 2004 and May 2015 at six large trauma centres. Multivariate Cox regression analysis was performed assessing the association of patient/treatment characteristics with THA likelihood at an average follow-up of 2.7 years (range 0.4-9.5 years; SD 1.8 years). RESULTS: Overall, the rate of secondary osteoarthritis was 19.8%. The likelihood for THA increased with 6% per age year (95% CI 1.04-1.09) and with 21% per millimetre subluxation (95%CI 1.09-1.33). This likelihood was 3.54 (95% CI 1.77-7.08) and 3.68 times (95% CI 1.87-7.47) higher if the posterior wall was involved and a contusion and/or impaction of the femoral head was present. Other covariates (sex, ISS, trauma type, AO/OTA and Letournel classification, initial displacement, surgical approach, intra-articular fragments, contusion and/or impaction to the acetabulum, reduction, intervention type, duration of surgery, soft tissue damage, residual fracture step/gap, and prevention of heterotopic ossifications) were not significantly associated (p > 0.15). CONCLUSIONS: Twenty percent of patients with acetabular fractures require THA. The associated risk factors are patient age, femoral head lesion/subluxation, and involvement of the posterior wall. The identified risk factors support previous research and should be minded when treatment of acetabular fractures is planned.

Dynamic intraligamentary stabilization of anterior cruciate ligament repair: hardware removal has no effect on knee laxity at 2-year follow-up.

INTRODUCTION: Dynamic intraligamentary stabilization (DIS) stabilizes the knee joint during anterior cruciate ligament (ACL) healing. After 6 months, tibial hardware removal is offered to the patients if local discomfort at the implant site is present. AIM: This study compared knee laxity and functional scores 2 years after DIS between patients with and without hardware removal. It is hypothesized that it does not affect ACL healing. MATERIALS AND METHODS: The study retrospectively analyzed prospectively collected data from 173 patients with either hardware removal (n = 47) or no additional intervention (n = 126). Inverse probability of treatment weighting using the propensity score was applied to balance the groups for baseline characteristics. The primary outcome was the side-to-side difference in knee laxity measured with the rolimeter at manual maximum force (Δ-Lachman). Secondary outcomes were the pivot-shift test and subjective scores. RESULTS: Mean age was 34 years in both groups, and female gender was 47% (hardware removal group) and 50% (control group), respectively. No significant differences were found for Δ-Lachman (p = 0.09), pivot-shift test (p = 0.41), and subjective scores (p > 0.10) two years after DIS. CONCLUSION: Knee laxity 2 years after DIS in patients with tibial hardware removal and patients without hardware removal was not significantly different. The groups were also similar regarding all the assessed functional scores. This study confirms the hypothesis that the healing ACL resumes its stabilizing role, and the hardware can be removed beginning 6 months after surgery without adverse consequences for joint stability. LEVEL OF EVIDENCE: Case-control study, Level III.

Patient and surgical characteristics that affect revision risk in dynamic intraligamentary stabilization of the anterior cruciate ligament.

PURPOSE: Failure of dynamic intraligamentary stabilization (DIS) that requires revision surgery of the anterior cruciate ligament (ACL) has not been studied. The aim of this study was to investigate the incidence of revision ACL surgery, and the patient characteristics and surgery-related factors that are associated with an increased risk of ACL revision after DIS. METHODS: This study analysed a prospective, consecutively documented single-centre case series using standardized case report forms over a 2.5-year follow-up period. The primary endpoint was revision ACL surgery. We used Kaplan-Meier analysis to examine the revision-free survival time, and a multiple logistic regression model of potential risk factors including age, sex, BMI, smoking status, previous contralateral ACL injury, Tegner activity score, interval to surgery, rupture pattern, hardware removal, and postoperative side-to-side difference in knee laxity. Relative risk was calculated for subgroups of significant risk factors. RESULTS: In total, 381 patients (195 male) with a mean age of 33 ± 12 years were included in the analysis. The incidence of revision ACL surgery was 30/381 (7.9%). Younger age (p = 0.001), higher Tegner activity score (p = 0.003), and increased knee laxity (p = 0.015) were significantly associated with revision ACL surgery. The increased relative risk for patients who were less than 24 years old, participated in activities at a Tegner level >5 points, or had >2 mm of side-to-side difference in knee laxity was 1.6, 3.7, and 2.3, respectively. CONCLUSION: Young age, high level of sport activity, and high knee laxity observed in follow-up examinations increased the likelihood for revision surgery after DIS. Patients undergoing DIS should be informed of their potentially increased risk for therapy failure and carefully monitored during recovery. LEVEL OF EVIDENCE: Case series, Level IV.

Predictors of improvement in quality of life and pain relief in lumbar spinal stenosis relative to patient age: a study based on the Spine Tango registry.

BACKGROUND: An open decompression is the most common treatment for lumbar spinal canal stenosis (LSS), even in the elderly. However, it is not clear whether the treatment outcome is age dependent. The main purpose of this study was to evaluate the improvement in quality of life (QoL) and pain relief, after open decompression for LSS in relation to patient age. METHODS: The study was performed on the basis of Spine Tango registry data. The database query resulted in 4768 patients from 40 international Spine Tango centres. The patients were subdivided into three age groups: (1) 20-64, (2) 65-74, and (3) ≥75 years. In multivariate logistic regression models, predictors for improvement in QoL and achievement of the minimum clinically relevant change in pain of two points were analysed. RESULTS: All groups benefited from significant improvement in QoL and back and leg pain relief. Age group had no significant influence on the outcomes. The preoperative status of each outcome was a predictor for its own postoperative outcome. Fewer previous surgeries, rigid or dynamic stabilization, and lower patient comorbidity also had a partially predictive influence for one or the other outcome. CONCLUSIONS: Our results confirm that all age groups significantly benefit from the open decompressive treatment of LSS. Age group had no significant influence on any outcome.

Incidental durotomy in decompression for lumbar spinal stenosis: incidence, risk factors and effect on outcomes in the Spine Tango registry.

PURPOSE: The three aims of this Spine Tango registry study of patients undergoing decompression for spinal stenosis were to: report the rate of dural tear (DT) stratified by treatment centre; find factors associated with an increased likelihood of incurring a DT; and compare treatment outcomes in relation to DT (none vs. repaired vs. unrepaired DT). METHODS: Multivariate logistic regression was used to assess the association between DT and patient and treatment characteristics. Patient-rated and surgical outcomes were compared in patients with no DT, repaired DT, and unrepaired DT, while adjusting for case-mix. RESULTS: DT occurred in 328/3254 (10.1%) of included patients. The rate for all 29 contributing hospitals was within 95% confidence intervals of the average. The likelihood of DT increased by 2% per year of age, 1.78 times with previous spine surgery, 1.67 for a minimally/less invasive surgery, 1.58 times with laminectomy, and 1.40, and 2.12 times for BMI 31-35, and >35 in comparison with BMI 26-30, respectively. The majority of DTs (272/328; 82.9%) were repaired. Repairing the DT was associated with a longer duration of surgery (p < 0.001). More patients with repaired than with unrepaired DTs were satisfied with treatment, but the difference was not statistically significant. There was no association between DT and patient-reported outcomes. CONCLUSION: The unadjusted rate of incidental DT during decompression for LSS was homogeneous across the participating centres and was associated with age, BMI, previous surgery at the same spinal level, minimally/less invasive surgery, and laminectomy. Non-repair of DTs had no negative association with treatment outcome; however, the unrepaired DTs may have been those that were smaller in size.

The Oswestry Disability Index, confirmatory factor analysis in a sample of 35,263 verifies a one-factor structure but practicality issues remain.

PURPOSE: To analyze the factor structure of the Oswestry Disability Index (ODI) in a large symptomatic low back pain (LBP) population using exploratory (EFA) and confirmatory factor analysis (CFA). METHODS: Analysis of pooled baseline ODI LBP patient data from the international Spine Tango registry of EUROSPINE, the Spine Society of Europe. The sample, with n = 35,263 (55.2% female; age 15-99, median 59 years), included 76.1% of patients with a degenerative disease, and 23.9% of the patients with various other spinal conditions. The initial EFA provided a hypothetical construct for consideration. Subsequent CFA was considered in three scenarios: the full sample and separate genders. Models were compared empirically for best fit. RESULTS: The EFA indicated a one-factor solution accounting for 54% of the total variance. The CFA analysis based on the full sample confirmed this one-factor structure. Sub-group analyses by gender achieved good model fit for configural and partial metric invariance, but not scalar invariance. A possible two-construct model solution as outlined by previous researchers: dynamic-activities (personal care, lifting, walking, sex and social) and static-activities (pain, sleep, standing, travelling and sitting) was not preferred. CONCLUSIONS: The ODI demonstrated a one-factor structure in a large LBP sample. A potential two-factor model was considered, but not found appropriate for constructs of dynamic and static activity. The use of the single summary score for the ODI is psychometrically supported. However, practicality limitations were reported for use in the clinical and research settings. Researchers are encouraged to consider a shift towards newer, more sensitive and robustly developed instruments.

Is the duration of pre-operative conservative treatment associated with the clinical outcome following surgical decompression for lumbar spinal stenosis? A study based on the Spine Tango Registry.

BACKGROUND: The incidence of lumbar spinal stenosis (LSS) continues to rise, with both conservative and surgical management representing options for its treatment. The timing of surgery for LSS varies from shortly after the onset of symptoms to several months or years after conservative treatment. The aim of this study was to investigate the association between the duration of pre-operative conservative treatment and the ultimate outcome following surgical interventions for LSS. METHODS: The study was based on prospective multicentre registry data (Spine Tango). Cases of LSS with a documented duration of conservative treatment, undergoing spinal decompression with at least one post-operative patient assessment between 3 and 30 months, were included in the study. Cases of LSS with spondylolisthesis, additional spinal pathology or previous spinal surgery were excluded. Interrogation of the Spine Tango Registry listed 3478 patients meeting the prescribed inclusion criteria. This cohort was stratified into four groups: (1) no previous treatment (n = 497; 14.3%), (2) conservative treatment <6 months (n = 965; 27.8%), (3) conservative treatment between 6 and 12 months (n = 758; 21.8%), and (4) conservative treatment >12 months (n = 1258; 36.1%). Group 4 reference group in regression analysis. The inverse probability of treatment weighting (IPTW) was applied using the propensity score to balance the groups for their characteristics. Outcome measures included achievement of the minimum clinically important change (MCIC) score of 2 points for (a) back pain, (b) leg pain and (c) Core Outcome Measures Index (COMI), and (d) surgical complications, (e) general complications and (f) operation time >2 h. RESULTS: Patient group ("duration of conservative therapy") was not associated with achievement of the MCIC for post-operative relief of leg pain (p = 0.22), achievement of MCIC for the COMI score (p = 0.054), surgical complications (p = 0.11) or general complications (p = 0.14). Only MCIC for post-operative relief of back pain (p = 0.021) and operation time were significantly associated with patient group (p = 0.038). However, compared with the reference group of >12 months of conservative treatment there was no significant difference in the likelihood of achieving the MCIC for those with none, <6 or 6-12 months of conservative treatment. CONCLUSIONS: The duration of pre-operative conservative treatment was not associated with the ultimate outcome of decompression surgery. Further research is required to investigate optimal thresholds/indications for surgery and its appropriate timing in individual patients.

Reduction of cement leakage by sequential PMMA application in a vertebroplasty model.

PURPOSE: Leakage is the most common complication of percutaneous cement augmentation of the spine. The viscosity of the polymethylmethacrylate (PMMA) cement is strongly correlated with the likelihood of cement leakage. We hypothesized that cement leakage can be reduced by sequential cement injection in a vertebroplasty model. METHODS: A standardized vertebral body substitute model, consisting of aluminum oxide foams coated by acrylic cement with a preformed leakage path, simulating a ventral vein, was developed. Three injection techniques of 6 ml PMMA were assessed: injection in one single step (all-in-one), injection of 1 ml at the first and 5 ml at the second step with 1 min latency in-between (two-step), and sequential injection of 0.5 ml with 1-min latency between the sequences (sequential). Standard PMMA vertebroplasty cement was used; each injection type was tested on ten vertebral body substitute models with two possible leakage paths per model. Leakage was assessed by radiographs using a zonal graduation: intraspongious = no leakage and extracortical = leakage. RESULTS: The leakage rate was significantly lower in the "sequential" technique (2/20 leakages) followed by "two-step" (15/20) and "all-in-one" (20/20) techniques (p < 0.001). The RR for a cement leakage was 10.0 times higher in the "all-in-one" compared to the "sequential" group (95 % confidence intervals 2.7-37.2; p < 0.001). CONCLUSIONS: The sequential cement injection is a simple approach to minimize the risk for leakage. Taking advantage of the temperature gradient between body and room temperature, it is possible to increase the cement viscosity inside the vertebra while keeping it low in the syringe. Using sequential injection of small cement volumes, further leakage paths are blocked before further injection of the low-viscosity cement.

Influence of previous surgery on patient-rated outcome after surgery for degenerative disorders of the lumbar spine.

PURPOSE: Few studies have used multivariate models to quantify the effect of multiple previous spine surgeries on patient-oriented outcome after spine surgery. This study sought to quantify the effect of prior spine surgery on 12-month postoperative outcomes in patients undergoing surgery for different degenerative disorders of the lumbar spine. METHODS: The study included 4940 patients with lumbar degenerative disease documented in the Spine Tango Registry of EUROSPINE, the Spine Society of Europe, from 2004 to 2015. Preoperatively and 12 months postoperatively, patients completed the multidimensional Core Outcome Measures Index (COMI; 0-10 scale). Patients' medical history and surgical details were recorded using the Spine Tango Surgery 2006 and 2011 forms. Multiple linear regression models were used to investigate the relationship between the number of previous surgeries and the 12-month postoperative COMI score, controlling for the baseline COMI score and other potential confounders. RESULTS: In the adjusted model including all cases, the 12-month COMI score showed a 0.37-point worse value [95 % confidence intervals (95 % CI) 0.29-0.45; p < 0.001] for each additional prior spine surgery. In the subgroup of patients with lumbar disc herniation, the corresponding effect was 0.52 points (95 % CI 0.27-0.77; p < 0.001) and in lumbar degenerative spondylolisthesis, 0.40 points (95 % CI 0.17-0.64; p = 0.001). CONCLUSIONS: We were able to demonstrate a clear "dose-response" effect for previous surgery: the greater the number of prior spine surgeries, the systematically worse the outcome at 12 months' follow-up. The results of this study can be used when considering or consenting a patient for further surgery, to better inform the patient of the likely outcome and to set realistic expectations.

Lavage prior to vertebral augmentation reduces the risk for cement leakage.

PURPOSE: This study aimed at assessing the cement leakage rate and the filling pattern in patients treated with vertebroplasty, kyphoplasty and stentoplasty with and without a newly developed lavage technique. STUDY DESIGN: Retrospective clinical case-control study. METHODS: A newly developed bipedicular lavage technique prior to cement application was applied in 64 patients (45.1 %) with 116 vertebrae, ("lavage" group). A conventional bipedicular cement injection technique was used in 78 patients (54.9 %) with 99 levels ("controls"). The outcome measures were filling patterns and leakage rates. RESULTS: The overall leakage rate (venous, cortical defect, intradiscal) was 37.9 % in the lavage and 83.8 % in the control group (p < 0.001). Venous leakage (lavage 12.9 % vs. controls 31.3 %; p = 0.001) and cortical defect leakage (lavage 17.2 % vs. controls 63.3 %; p < 0.001) were significantly lower in the lavage group compared to "controls," whereas intradiscal leakages were similar in both groups (lavage 12.1 % vs. controls 15.2 %; p = 0.51). For venous leakage multivariate logistic regression analysis showed lavage to be the only independent predictor. Lavage was associated with 0.33-times (95 % CI 0.16-0.65; p = 0.001) lower likelihood for leakage in compared to controls. CONCLUSIONS: Vertebral body lavage prior to cement augmentation is a safe technique to reduce cement leakage in a clinical setting and has the potential to prevent pulmonary fat embolism. Moreover, a better filling pattern can be achieved.

Patient outcomes after laminotomy, hemilaminectomy, laminectomy and laminectomy with instrumented fusion for spinal canal stenosis: a propensity score-based study from the Spine Tango registry.

PURPOSE: To compare patient outcomes and complication rates after different decompression techniques or instrumented fusion (IF) in lumbar spinal stenosis (LSS). METHODS: The multicentre study was based on Spine Tango data. Inclusion criteria were LSS with a posterior decompression and pre- and postoperative COMI assessment between 3 and 24 months. 1,176 cases were assigned to four groups: (1) laminotomy (n = 642), (2) hemilaminectomy (n = 196), (3) laminectomy (n = 230) and (4) laminectomy combined with an IF (n = 108). Clinical outcomes were achievement of minimum relevant change in COMI back and leg pain and COMI score (2.2 points), surgical and general complications, measures taken due to complications, and reintervention on the index level based on patient information. The inverse propensity score weighting method was used for adjustment. RESULTS: Laminotomy, hemilaminectomy and laminectomy were significantly less beneficial than laminectomy in combination with IF regarding leg pain (ORs with 95% CI 0.52, 0.34-0.81; 0.25, 0.15-0.41; 0.44, 0.27-0.72, respectively) and COMI score improvement (ORs with 95% CI 0.51, 0.33-0.81; 0.30, 0.18-0.51; 0.48, 0.29-0.79, respectively). However, the sole decompressions caused significantly fewer surgical (ORs with 95% CI 0.42, 0.26-0.69; 0.33, 0.17-0.63; 0.39, 0.21-0.71, respectively) and general complications (ORs with 95% CI 0.11, 0.04-0.29; 0.03, 0.003-0.41; 0.25, 0.09-0.71, respectively) than laminectomy in combination with IF. Accordingly, the likelihood of required measures was also significantly lower after laminotomy (OR 0.28, 95% CI 0.17-0.46), hemilaminectomy (OR 0.28, 95% CI 0.15-0.53) and after laminectomy (OR 0.39, 95% CI 0.22-0.68) in comparison with laminectomy with IF. The likelihood of a reintervention was not significantly different between the treatment groups. DISCUSSION: As already demonstrated in the literature, decompression in patients with LSS is a very effective treatment. Despite better patient outcomes after laminectomy in combination with IF, caution is advised due to higher rates of surgical and general complications and consequent required measures. Based on the current study, laminotomy or laminectomy, rather than hemilaminectomy, is recommendable for minimum relevant pain relief.

Driving and emergency braking may be impaired after tibiotalar joint arthrodesis: conclusions after a case series.

PURPOSE: To assess whether reaction time (RT) and movement time (MT), as the two components of the total brake response time (TBRT) and brake force (BF) are different in patients with a foot joint arthrodesis in comparison to controls. METHODS: The study was a comparative case series in a driving simulator under realistic driving conditions. Mobile patients without a walker, ≥6 months after surgery who were driving a car and had no neurological co-morbidity, knee or hip joint prosthesis were included in the study. The selection criteria resulted in 12 patients with right tibiotalar joint arthrodesis (TTJA) and 12 patients with another right foot joint arthrodesis (OFJA), who were compared to 17 individuals without any ankle-joint pathology. For TBRT, an empirical safe driving threshold of 700 ms was used. The outcome measures were RT, MT, TBRT, BF and McGuire score. RESULTS: MT (p = 0.034) and TBRT (p = 0.026) were longer in TTJA patients in comparison with the controls. Also, more patients with TTJA than patients with OFJA and controls exceeded the safe driving threshold (p = 0.028). The outcomes in OFJA patients and in controls were comparable. The McGuire score was similar between the TTJA and OFJA patients (p = 0.26). CONCLUSIONS: Significantly slower MT and TBRT, and significantly more patients exceeding the safe driving threshold, were observed after a tibiotalar-joint arthrodesis in comparison to the controls. Patients with OFJAs were not significantly different from the controls. Driving and emergency braking may be impaired after tibiotalar-joint arthrodesis.

Development and validation of a quantitative method to assess pedicle screw loosening in posterior spine instrumentation on plain radiographs.

PURPOSE: Currently, the diagnosis of pedicle screw (PS) loosening is based on a subjectively assessed halo sign, that is, a radiolucent line around the implant wider than 1 mm in plain radiographs. We aimed at development and validation of a quantitative method to diagnose PS loosening on radiographs. METHODS: Between 11/2004 and 1/2010 36 consecutive patients treated with thoraco-lumbar spine fusion with PS instrumentation without PS loosening were compared with 37 other patients who developed a clinically manifesting PS loosening. Three different angles were measured and compared regarding their capability to discriminate the loosened PS over the postoperative course. The inter-observer invariance was tested and a receiver operating characteristics curve analysis was performed. RESULTS: The angle measured between the PS axis and the cranial endplate was significantly different between the early and all later postoperative images. The Spearman correlation coefficient for the measurements of two observers at each postoperative time point ranged between 0.89 at 2 weeks to 0.94 at 2 months and 1 year postoperative. The angle change of 1.9° between immediate postoperative and 6-month postoperative was 75% sensitive and 89% specific for the identification of loosened screws (AUC = 0.82). DISCUSSION: The angle between the PS axis and the cranial endplate showed good ability to change in PS loosening. A change of this angle of at least 2° had a relatively high sensitivity and specificity to diagnose screw loosening.

Incidence and risk factors for early adjacent vertebral fractures after balloon kyphoplasty for osteoporotic fractures: analysis of the SWISSspine registry.

PURPOSE: The SWISSspine registry (SSR) was launched in 2005 to assess the safety and effectiveness of balloon kyphoplasty (BKP). In the meantime, repeated reports on high rates of adjacent vertebral fractures (ASF) after BKP of vertebral insufficiency fractures were published. The causes for ASF and their risk factors are still under debate. The purpose of this study was to report the incidence and potential risk factors of ASF within the SSR dataset. METHODS: The SSR data points are collected perioperatively and during follow-ups, with surgeon- and patient-based information. All patients documented with a monosegmental osteoporotic vertebral insufficiency fracture between March 2005 and May 2012 were included in the study. The incidence of ASF, significant associations with co-variates (patient age, gender, fracture location, cement volume, preoperative segmental kyphosis, extent of kyphosis correction, and individual co-morbidities) and influence on quality of life (EQ-5D) and back pain (VAS) were analyzed. RESULTS: A total of 375 patients with a mean follow-up of 3.6 months was included. ASF were found in 9.9 % (n = 37) and occurred on average 2.8 months postoperatively. Preoperative segmental kyphosis >30° (p = 0.026), and rheumatoid arthritis (p = 0.038) and cardiovascular disease (p = 0.047) were significantly associated with ASF. Furthermore, patients with ASF had significantly higher back pain at the final follow-up (p = 0.001). No further significant associations between the studied co-variates and ASF were seen in the adjusted analysis. CONCLUSIONS: The findings suggest that patients with a preoperative segmental kyphosis >30° or patients with co-morbidities like rheumatoid arthritis and a cardiovascular disease are at high risk of ASF within 6 months after the index surgery. In case of an ASF event, back pain levels are significantly increased. LEVEL OF EVIDENCE: IV.

Five-year results of lumbar disc prostheses in the SWISSspine registry.

PURPOSE: The Swiss Federal Office of Public Health demanded a nationwide HTA registry for lumbar total disc arthroplasty (TDA), to decide about its reimbursement. The goal of the SWISS spine registry is to generate evidence about the safety and efficiency of lumbar TDA. METHODS: Two hundred forty-eight cases treated between 3-2005 and 6-2006, who were eligible for the 5-year follow-up were included in the study. Follow-up rates for 3-6 months, 1, 2 and 5 years were 85.9, 77.0, 44.0 and 51.2 %, respectively. Outcome measures were back and leg pain, medication consumption, quality of life, intraoperative and postoperative complication and revision rates. Additionally, segmental mobility, ossification, adjacent and distant segment degeneration were analysed at the 5-year follow-up. RESULTS: There was a significant, clinically relevant and lasting reduction of back (preop/postop 73/29 VAS points) and leg pain (preop/postop VAS 55/22) and a consequently decreased analgesics consumption and quality of life improvement (preop/postop 0.30/0.76 EQ-5D score points) until 5 years after surgery. The rates for intraoperative and early postoperative complications were 4.4 and 3.2 %, respectively. The overall complication rate during five postoperative years was 23.4 %, and the adjacent segment degeneration rate was 10.7 %. In 4.4 % of patients, a revision surgery was performed. Cumulative survivorship probability for a revision/re-intervention-free 5-year postoperative course was 90.4 %. At the 5-year follow-up, the average range of motion of the mobile segments (86.8 %) was 9.7°. In 43.9 % of patients, osteophytes at least potentially affecting the range of motion were seen. CONCLUSIONS: Lumbar TDA appeared as efficient in long-term pain alleviation, consequent reduction of pain medication consumption and improvement of quality of life. The procedure also appeared sufficiently safe, but surgeons have to be aware of a list of potential adverse events. The outcome is stable over the 5-year postoperative period. The vast majority of treated segments remained mobile after 5 years, although almost half of patients showed osteophytes.

What is the frequency of nerve injuries associated with acetabular fractures?

BACKGROUND: Acetabular fractures and surgical interventions used to treat them can result in nerve injuries. To date, only small case studies have tried to explore the frequency of nerve injuries and their association with patient and treatment characteristics. High-quality data on the risk of traumatic and iatrogenic nerve lesions and their epidemiology in relation to different fracture types and surgical approaches are lacking. QUESTIONS/PURPOSES: The purpose of this study was to determine (1) the proportion of patients who develop nerve injuries after acetabular fracture; (2) which fracture type(s) are associated with increased nerve injury risk; and (3) which surgical approach was associated with the highest proportion of patients developing nerve injuries using data from the German Pelvic Trauma Registry. Two secondary aims were (4) to assess hospital volume-nerve-injury relationship; and (5) internal data validity. METHODS: Between March 2001 and June 2012, 2236 patients with acetabular fractures were entered into a prospectively maintained registry from 29 hospitals; of those, 2073 (92.7%) had complete records on the endpoints of interest in this retrospective study and were analyzed. The neurological status in these patients was captured at their admission and at the discharge. A total of 1395 of 2073 (67%) patients underwent surgery, and the proportions of intervention-related and other hospital-acquired nerve injuries were obtained. Overall proportions of patients developing nerve injuries, risk based on fracture type, and risk of surgical approach type were analyzed. RESULTS: The proportion of patients being diagnosed with nerve injuries at hospital admission was 4% (76 of 2073) and at discharge 7% (134 or 2073). Patients with fractures of the "posterior wall" (relative risk [RR], 2.0; 95% confidence interval [CI], 1.4-2.8; p=0.001), "posterior column and posterior wall" (RR, 2.9; CI, 1.6-5.0; p=0.002), and "transverse+posterior wall" fracture (RR, 2.1; CI, 1.3-3.5; p=0.010) were more likely to have nerve injuries at hospital discharge. The proportion of patients with intervention-related nerve injuries and that of patients with other hospital-acquired nerve injuries was 2% (24 of 1395 and 46 of 2073, respectively). They both were associated with the Kocher-Langenbeck approach (RR, 3.0; CI, 1.4-6.2; p=0.006; and RR, 2.4; CI, 1.4-4.3; p=0.004, respectively). CONCLUSIONS: Acetabular fractures with the involvement of posterior wall were most commonly accompanied with nerve injuries. The data suggest also that Kocher-Langenbeck approach to the pelvic ring is associated with a higher risk of perioperative nerve injuries. Trauma surgeons should be aware of common nerve injuries, particularly in posterior wall fractures. The results of the study should help provide patients with more exact information on the risk of perioperative nerve injuries in acetabular fractures. LEVEL OF EVIDENCE: Level III, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Short-term functional versus patient-reported outcome of the bicruciate stabilized total knee arthroplasty: prospective consecutive case series.

BACKGROUND: The main goals of the standard treatment for advanced symptomatic knee osteoarthritis, total knee arthroplasty (TKA), are pain reduction and restoration of knee motion.The aim of this study was to analyse the outcome of the patient-based Knee Injury and Osteoarthritis Outcome Score (KOOS), and the surgeon-based Knee Society Score (KSS) and its Knee Score (KS) and Knee Functional Score (KFS) components after (TKA) using the Journey knee prosthesis, and to assess the correlation of these scores with range of motion (ROM). METHODS: In a prospective case series study between August 1st 2008 and May 31st 2011, 99 patients, all operated by a single surgeon, received Journey bicruciate stabilized total knee prostheses. The female/male ratio was 53/34, the mean patient age at surgery was 68 years (range 41-83 years), and the left/right knee ratio was 55/44. The KOOS, range of motion, and KS and KFS were obtained preoperatively and at 1-year follow-up. The pre- and postoperative levels of the outcome measures were compared using the Wilcoxon signed-rank test. Correlation between ROM and patient outcomes was analysed with the Spearman coefficient. RESULTS: All KOOS subscores improved significantly. Ninety percent of patients improved by at least the minimum clinically relevant difference of 10 points in stiffness and other symptoms, 94.5% in pain, 94.5% in activities of daily living, 84.9% in sports and recreation, and 90% in knee-related quality of life. The mean passive and active ROM improved from 122.4° (range 90-145°) and 120.4° (range 80-145°) preoperatively to 129.4° (range 90-145°) and 127.1° (range 100-145°) postoperatively. The highest correlation coefficients for ROM and KOOS were observed for the activity and pain subscores. Very low or no correlation was seen for the sport subscore.There was a significant and clinically relevant improvement of KSS (preop/postop 112.2/174.5 points), and its KS (preop/postop 45.6/86.8 points) and KFS (preop/postop 66.6/87.8 points) components. CONCLUSIONS: The Journey bicruciate stabilized knee prosthesis showed good 1-year postoperative results in terms of both functional and patient-based outcome. However, higher knee ROM correlates only moderately with patient-based outcome, implying that functionality afforded by the Journey bicruciate TKA is not equivalent to patient satisfaction.