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 versus conventional ACL reconstruction: A matched study on return to work.

PURPOSE: The dynamic intraligamentary stabilization (DIS) technique is based on a different treatment approach than ACL reconstruction in that it intends to promote self-healing of the ligament. It is only recommended for acute injuries (<21days). The purpose of the present study was to compare DIS and ACLR with respect to the extent of work incapacity, revision rates, secondary arthroscopies, and treatment costs during recovery. METHODS: The study was a post-hoc analysis of prospectively collected data in the Swiss National Accident Insurance Fund (SUVA) database. All registered DIS cases treated until 31 December 2012 were included in the study. ACLR cases were matched to DIS cases using a propensity score approach and analysed in a follow-up period of 2 years after injury. Paired Student's T-test and the Chi-square test were used to compare the outcome measures. RESULTS: All 53 DIS patients were matched to an ACLR pair. The mean time period from injury to surgery was 14days for DIS and 50days for ACLR (p<0.001). Overall work incapacity was 13% for DIS and 17% for ACLR resulting in a difference of nearly 1 month of absence from work (p=0.03). The course of postoperative work incapacity was very similar between the groups, while the work incapacity prior to surgery lower in the DIS group. We found no difference in treatment costs, secondary arthroscopies and revision rates. CONCLUSION: DIS patients benefited from nearly one month shorter absence from work than ACLR patients. This difference is likely related to the early surgical timing that is recommended for DIS. Since no differences were found between DIS and ACLR in terms of treatment costs, secondary arthroscopies and revision rates, the study supports the choice of DIS as an additional treatment option for acute ACL injuries. Further comparative studies are proposed to improve the evidence about optimal timing and best practice in ACL treatment.

Factor analysis of the North American Spine Society outcome assessment instrument: a study based on a spine registry of patients treated with lumbar and cervical disc arthroplasty.

BACKGROUND CONTEXT: Studies involving factor analysis (FA) of the items in the North American Spine Society (NASS) outcome assessment instrument have revealed inconsistent factor structures for the individual items. PURPOSE: This study examined whether the factor structure of the NASS varied in relation to the severity of the back/neck problem and differed from that originally recommended by the developers of the questionnaire, by analyzing data before and after surgery in a large series of patients undergoing lumbar or cervical disc arthroplasty. STUDY DESIGN/SETTING: Prospective multicenter observational case series. PATIENT SAMPLE: Three hundred ninety-one patients with low back pain and 553 patients with neck pain completed questionnaires preoperatively and again at 3 to 6 and 12 months follow-ups (FUs), in connection with the SWISSspine disc arthroplasty registry. OUTCOME MEASURES: North American Spine Society outcome assessment instrument. METHODS: First, an exploratory FA without a priori assumptions and subsequently a confirmatory FA were performed on the 17 items of the NASS-lumbar and 19 items of the NASS-cervical collected at each assessment time point. The item-loading invariance was tested in the German version of the questionnaire for baseline and FU. RESULTS: Both NASS-lumbar and NASS-cervical factor structures differed between baseline and postoperative data sets. The confirmatory analysis and item-loading invariance showed better fit for a three-factor (3F) structure for NASS-lumbar, containing items on "disability," "back pain," and "radiating pain, numbness, and weakness (leg/foot)" and for a 5F structure for NASS-cervical including disability, "neck pain," "radiating pain and numbness (arm/hand)," "weakness (arm/hand)," and "motor deficit (legs)." CONCLUSIONS: The best-fitting factor structure at both baseline and FU was selected for both the lumbar- and cervical-NASS questionnaires. It differed from that proposed by the originators of the NASS instruments. Although the NASS questionnaire represents a valid outcome measure for degenerative spine diseases, it is able to distinguish among all major symptom domains (factors) in patients undergoing lumbar and cervical disc arthroplasty; overall, the item structure could be improved. Any potential revision of the NASS should consider its factorial structure; factorial invariance over time should be aimed for, to allow for more precise interpretations of treatment success.

Real-life results of balloon kyphoplasty for vertebral compression fractures from the SWISSspine registry.

BACKGROUND CONTEXT: The Swiss Federal Office of Public Health mandated a nationwide health technology assessment-registry for balloon kyphoplasty (BKP) for decision making on reimbursement of these interventions. The early results of the registry led to a permanent coverage of BKP by basic health insurance. The documentation was continued for further evidence generation. PURPOSE: This analysis reports on the 1 year results of patients after BKP treatment. STUDY DESIGN: Prospective multicenter observational case series. PATIENT SAMPLE: The data on 625 cases with 819 treated vertebrae were documented from March 2005 to May 2012. OUTCOME MEASURES: Surgeon-administered outcome instruments were primary intervention form for BKP and the follow-up form; patient self-reported measures were EuroQol-5D questionnaire, North American Spine Society outcome instrument /Core Outcome Measures Index (including visual analog scale), and a comorbidity questionnaire. Outcome measures were back pain, medication, quality of life (QoL), cement extrusions, and new fractures within the first postoperative year. METHODS: Data were recorded preoperatively and at 3 to 6-month and 1-year follow-ups. Wilcoxon signed-rank test was used for comparison of pre- with postoperative measurements. Multivariate logistic regression was used to identify factors with a significant influence on the outcome. RESULTS: Seventy percent of patients were women with mean age of 71 years (range, 18-91 years); mean age of men was 65 years (range, 15-93 years). Significant and clinically relevant reduction of back pain, improvement of QoL, and reduction of pain killer consumption was seen within the first postoperative year. Preoperative back pain decreased from 69.3 to 29.0 at 3 to 6-month and remained unchanged at 1-year follow-ups. Consequently, QoL improved from 0.23 to 0.71 and 0.75 at the same follow-up intervals. The overall vertebra-based cement extrusion rates with and without extrusions into intervertebral discs were 22.1% and 15.3%, respectively. Symptomatic cement extrusions with radiculopathy were five (0.8%). A new vertebral fracture within a year from the BKP surgery was observed in 18.4% of the patients. CONCLUSIONS: The results of the largest observational study for BKP so far are consistent with published randomized trials and systematic reviews. In this routine health care setting, BKP is safe and effective in reducing pain, improving QoL, and lowering pain_killer consumption and has an acceptable rate of cement extrusions. Postoperative outcome results show clear and significant clinical improvement at early follow-up that remain stable during the first postoperative year.

Influence of preoperative leg pain and radiculopathy on outcomes in mono-segmental lumbar total disc replacement: results from a nationwide registry.

PURPOSE: Currently, many pre-conditions are regarded as relative or absolute contraindications for lumbar total disc replacement (TDR). Radiculopathy is one among them. In Switzerland it is left to the surgeon's discretion when to operate if he adheres to a list of pre-defined indications. Contraindications, however, are less clearly specified. We hypothesized that, the extent of pre-operative radiculopathy results in different benefits for patients treated with mono-segmental lumbar TDR. We used patient perceived leg pain and its correlation with physician recorded radiculopathy for creating the patient groups to be compared. METHODS: The present study is based on the dataset of SWISSspine, a government mandated health technology assessment registry. Between March 2005 and April 2009, 577 patients underwent either mono- or bi-segmental lumbar TDR, which was documented in a prospective observational multicenter mode. A total of 416 cases with a mono-segmental procedure were included in the study. The data collection consisted of pre-operative and follow-up data (physician based) and clinical outcomes (NASS form, EQ-5D). A receiver operating characteristic (ROC) analysis was conducted with patients' self-indicated leg pain and the surgeon-based diagnosis "radiculopathy", as marked on the case report forms. As a result, patients were divided into two groups according to the severity of leg pain. The two groups were compared with regard to the pre-operative patient characteristics and pre- and post-operative pain on Visual Analogue Scale (VAS) and quality of life using general linear modeling. RESULTS: The optimal ROC model revealed a leg pain threshold of 40 ≤ VAS > 40 for the absence or the presence of "radiculopathy". Demographics in the resulting two groups were well comparable. Applying this threshold, the mean pre-operative leg pain level was 16.5 points in group 1 and 68.1 points in group 2 (p < 0.001). Back pain levels differed less with 63.6 points in group 1 and 72.6 in group 2 (p < 0.001). Pre-operative quality of life showed considerable differences with an 0.44 EQ-5D score in group 1 and 0.29 in group 2 (p < 0.001, possible score range -0.6 to 1). At a mean follow-up time of 8 months, group 1 showed a mean leg pain improvement of 3.6 points and group 2 of 41.1 points (p < 0.001). Back pain relief was 35.6 and 39.1 points, respectively (p = 0.27). EQ-5D score improvement was 0.27 in group 1 and 0.41 in group 2 (p = 0.11). CONCLUSIONS: Patients labeled as having radiculopathy (group 2) do mostly have pre-operative leg pain levels ≥ 40. Applying this threshold, the patients with pre-operative leg pain do also have more severe back pain and a considerably lower quality of life. Their net benefit from the lumbar TDR is higher and they do have similar post-operative back and leg pain levels as well as the quality of life as patients without pre-operative leg pain. Although randomized controlled trials are required to confirm these findings, they put leg pain and radiculopathy into perspective as absolute contraindications for TDR.

Influence of preoperative nucleus pulposus status and radiculopathy on outcomes in mono-segmental lumbar total disc replacement: results from a nationwide registry.

BACKGROUND: Currently, herniated nucleus pulposus (HNP) with radiculopathy and other preconditions are regarded as relative or absolute contraindications for lumbar total disc replacement (TDR). In Switzerland it is left to the surgeon's discretion when to operate. The present study is based on the dataset of SWISSspine, a governmentally mandated health technology assessment registry. We hypothesized that preoperative nucleus pulposus status and presence or absence of radiculopathy has an influence on clinical outcomes in patients treated with mono-segmental lumbar TDR. METHODS: Between March 2005 and April 2009, 416 patients underwent mono-segmental lumbar TDR, which was documented in a prospective observational multicenter mode. The data collection consisted of perioperative and follow-up data (physician based) and clinical outcomes (NASS, EQ-5D).Patients were divided into four groups according to their preoperative status: 1) group degenerative disc disease ("DDD"): 160 patients without HNP and no radiculopathy, classic precondition for TDR; 2) group "HNP-No radiculopathy": 68 patients with HNP but without radiculopathy; 3) group "Stenosis": 73 patients without HNP but with radiculopathy, and 4) group "HNP-Radiculopathy": 132 patients with HNP and radiculopathy. The groups were compared regarding preoperative patient characteristics and pre- and postoperative VAS and EQ-5D scores using general linear modeling. RESULTS: Demographics in all four groups were comparable. Regarding the improvement of quality of life (EQ-5D) there were no differences across the four groups. For the two main groups DDD and HNP-Radiculopathy no differences were found in the adjusted postoperative back- and leg pain alleviation levels, in the stenosis group back- and leg pain relief were lower. CONCLUSIONS: Despite higher preoperative leg pain levels, outcomes in lumbar TDR patients with HNP and radiculopathy were similar to outcomes in patients with the classic indication; this because patients with higher preoperative leg pain levels benefit from a relatively greater leg pain alleviation. The group with absence of HNP but presence of radiculopathy showed considerably less benefits from the operation, which is probably related to ongoing degenerative processes of the posterior segmental structures. This observational multicenter study suggests that the diagnoses HNP and radiculopathy, combined or alone, may not have to be considered as absolute or relative contraindications for mono-segmental lumbar TDR anymore, whereas patients without HNP but with radiculopathy seem to be suboptimal candidates for the procedure.

SWISSspine: the case of a governmentally required HTA-registry for total disc arthroplasty: results of cervical disc prostheses.

STUDY DESIGN: Prospective multicenter observational case-series. OBJECTIVE: The goal of the SWISSspine registry is to generate evidence about the safety and efficiency of these Medtech innovations. SUMMARY OF BACKGROUND DATA: The Swiss federal office of public health required a mandatory nationwide HTA-registry for cervical total disc arthroplasty (TDA), among other technologies, to decide about reimbursement of these interventions. METHODS: Between March 2005 and June 2008, 808 interventions with implantation of 925 discs from 5 different suppliers were performed. Surgeon-administered outcome instruments were primary intervention, implant, and follow-up forms; patient self-reported measures were EQ-5D, COSS, and a comorbidity questionnaire. Data are recorded perioperative, at 3 months and 1 year postoperative, and annually thereafter. RESULTS. There was significant and clinically relevant reduction of neck (preoperative/postoperative 59.3/24.8 points) and arm pain (preoperative/postoperative 64.9/17.6) on visual analogue scale (VAS) and consequently decreased analgesics consumption. Similarly, quality of life (QoL) improved from preoperative 0.42 to postoperative 0.82 points on EQ-5D scale. There were 4 intraoperative complications and 23 revisions during the same hospitalization for 691 monosegmental TDAs, and 2 complications and 6 revisions for 117 2-level surgeries. A pharmacologically treated depression was identified as important risk factor for achieving a clinically relevant pain alleviation >20 points on VAS. Two-level surgery resulted in similar outcomes compared with the monosegmental interventions. CONCLUSION: Cervical TDA appeared as safe and efficacious in short-term pain alleviation, consequent reduction of pain killer consumption, and in improvement of QoL. A clinically relevant pain reduction of ≥20 points was most probable if patients had preoperative pain levels ≥40 points on VAS. A pharmacologically treated depression and 2-level surgery were identified as risk factors for less pronounced pain alleviation or QoL improvement.

SWISSspine-a nationwide health technology assessment registry for balloon kyphoplasty: methodology and first results.

BACKGROUND CONTEXT: The Swiss Federal Office of Public Health demanded a nationwide health technology assessment registry for cervical and lumbar total disc arthroplasty and for balloon kyphoplasty (BKP) to make a decision about reimbursement of these interventions. PURPOSE: The goal of the SWISSspine registry is to generate evidence about the safety and effectiveness of these technologies. We report on results of patients with balloon kyphoplasty. STUDY DESIGN/SETTING: Prospective, multicenter, observational case series. PATIENT SAMPLE: From March 2005 until June 2008, 331 interventions with 391 treated levels in 320 patients have been documented. 75.6% of patients were females with mean age of 74 years (range 43-95.2 years); mean age of males was 72.6 years (range 41.4-93 years). OUTCOME MEASURES: Surgeon-administered outcome instruments were primary intervention form for BKP, implant, and follow-up form; patient self-reported measures were Euroqol-5D, North American Spine Society, and a comorbidity questionnaire. METHODS: Data were recorded perioperative, at 3 months, 1 year, and annually thereafter. Wilcoxon signed-rank test was used for comparison of preoperative to postoperative measurements. Multivariate regression was used for identifying factors with a significant influence on the outcome. RESULTS: Significant and clinically relevant reduction of back pain, improvement of quality of life (QoL), and reduction of pain killer consumption were seen in the 1-year follow-up. Improvement of preoperative segmental kyphosis was achieved in the majority of cases. There were three symptomatic cement extrusions with radiculopathy documented. CONCLUSIONS: Balloon kyphoplasty is a safe and effective treatment concerning pain reduction, QoL improvement, and pain killer consumption. The SWISSspine registry proved to be an excellent tool for evaluation of this new technology, and its results, in combination with an elaborate health technology assessment report, led to a permanent coverage of BKP by the basic health insurance.

Differences across health care systems in outcome and cost-utility of surgical and conservative treatment of chronic low back pain: a study protocol.

BACKGROUND: There is little evidence on differences across health care systems in choice and outcome of the treatment of chronic low back pain (CLBP) with spinal surgery and conservative treatment as the main options. At least six randomised controlled trials comparing these two options have been performed; they show conflicting results without clear-cut evidence for superior effectiveness of any of the evaluated interventions and could not address whether treatment effect varied across patient subgroups. Cost-utility analyses display inconsistent results when comparing surgical and conservative treatment of CLBP. Due to its higher feasibility, we chose to conduct a prospective observational cohort study. METHODS: This study aims to examine if1. Differences across health care systems result in different treatment outcomes of surgical and conservative treatment of CLBP2. Patient characteristics (work-related, psychological factors, etc.) and co-interventions (physiotherapy, cognitive behavioural therapy, return-to-work programs, etc.) modify the outcome of treatment for CLBP3. Cost-utility in terms of quality-adjusted life years differs between surgical and conservative treatment of CLBP. This study will recruit 1000 patients from orthopaedic spine units, rehabilitation centres, and pain clinics in Switzerland and New Zealand. Effectiveness will be measured by the Oswestry Disability Index (ODI) at baseline and after six months. The change in ODI will be the primary endpoint of this study. Multiple linear regression models will be used, with the change in ODI from baseline to six months as the dependent variable and the type of health care system, type of treatment, patient characteristics, and co-interventions as independent variables. Interactions will be incorporated between type of treatment and different co-interventions and patient characteristics. Cost-utility will be measured with an index based on EQol-5D in combination with cost data. CONCLUSION: This study will provide evidence if differences across health care systems in the outcome of treatment of CLBP exist. It will classify patients with CLBP into different clinical subgroups and help to identify specific target groups who might benefit from specific surgical or conservative interventions. Furthermore, cost-utility differences will be identified for different groups of patients with CLBP. Main results of this study should be replicated in future studies on CLBP.

Virtopsy: postmortem imaging of the human heart in situ using MSCT and MRI.

The rapid further development of computed tomography (CT) and magnetic resonance imaging (MRI) induced the idea to use these techniques for postmortem documentation of forensic findings. Until now, only a few institutes of forensic medicine have acquired experience in postmortem cross-sectional imaging. Protocols, image interpretation and visualization have to be adapted to the postmortem conditions. Especially, postmortem alterations, such as putrefaction and livores, different temperature of the corpse and the loss of the circulation are a challenge for the imaging process and interpretation. Advantages of postmortem imaging are the higher exposure and resolution available in CT when there is no concern for biologic effects of ionizing radiation, and the lack of cardiac motion artifacts during scanning. CT and MRI may become useful tools for postmortem documentation in forensic medicine. In Bern, 80 human corpses underwent postmortem imaging by CT and MRI prior to traditional autopsy until the month of August 2003. Here, we describe the imaging appearance of postmortem alterations--internal livores, putrefaction, postmortem clotting--and distinguish them from the forensic findings of the heart, such as calcification, endocarditis, myocardial infarction, myocardial scarring, injury and other morphological alterations.