Development of a mapping function ("crosswalk") for the conversion of scores between the Oswestry Disability Index (ODI) and the Core Outcome Measures Index (COMI).

INTRODUCTION: The Oswestry Disability Index (ODI) and the Core Outcome Measures Index (COMI) are two commonly used self-rating outcome instruments in patients with lumbar spinal disorders. No formal crosswalk between them exists that would otherwise allow the scores of one to be interpreted in terms of the other. We aimed to create such a mapping function. METHODS: We performed a secondary analysis of ODI and COMI data previously collected from 3324 patients (57 ± 17y; 60.3% female) at baseline and 1y after surgical or conservative treatment. Correlations between scores and Cohen's kappa for agreement (κ) regarding achievement of the minimal clinically important change (MCIC) score on each instrument (ODI, 12.8 points; COMI, 2.2 points) were calculated, and regression models were built. The latter were tested for accuracy in an independent set of registry data from 634 patients (60 ± 15y; 56.8% female). RESULTS: All pairs of measures were significantly positively correlated (baseline, 0.73; 1y follow-up (FU), 0.84; change-scores, 0.73). MCIC for COMI was achieved in 53.9% patients and for ODI, in 52.4%, with 78% agreement on an individual basis (κ = 0.56). Standard errors for the regression slopes and intercepts were low, indicating excellent prediction at the group level, but root mean square residuals (reflecting individual error) were relatively high. ODI was predicted as COMI × 7.13-4.20 (at baseline), COMI × 6.34 + 2.67 (at FU) and COMI × 5.18 + 1.92 (for change-score); COMI was predicted as ODI × 0.075 + 3.64 (baseline), ODI × 0.113 + 0.96 (FU), and ODI × 0.102 + 1.10 (change-score). ICCs were 0.63-0.87 for derived versus actual scores. CONCLUSION: Predictions at the group level were very good and met standards justifying the pooling of data. However, we caution against using individual values for treatment decisions, e.g. attempting to monitor patients over time, first with one instrument and then with the other, due to the lower statistical precision at the individual level. The ability to convert scores via the developed mapping function should open up more centres/registries for collaboration and facilitate the combining of data in meta-analyses.

Lumbar Spinal Stenosis Severity by CT or MRI Does Not Predict Response to Epidural Corticosteroid versus Lidocaine Injections.

BACKGROUND AND PURPOSE: Epidural steroid injections may offer little-to-no short-term benefit in the overall population of patients with symptomatic spinal stenosis compared with lidocaine alone. We investigated whether imaging could identify subgroups of patients who might benefit most. MATERIALS AND METHODS: A secondary analysis of the Lumbar Epidural Steroid Injections for Spinal Stenosis prospective, double-blind trial was performed, and patients were randomized to receive an epidural injection of lidocaine with or without corticosteroids. Patients (n = 350) were evaluated for qualitative and quantitative MR imaging or CT measures of lumbar spinal stenosis. The primary clinical end points were the Roland-Morris Disability Questionnaire and the leg pain numeric rating scale at 3 weeks following injection. ANCOVA was used to assess the significance of interaction terms between imaging measures of spinal stenosis and injectate type on clinical improvement. RESULTS: There was no difference in the improvement of disability or leg pain scores at 3 weeks between patients injected with epidural lidocaine alone compared with corticosteroid and lidocaine when accounting for the primary imaging measures of qualitative spinal stenosis assessment (interaction coefficients for disability score, -0.1; 95% CI, -1.3 to 1.2; P = .90; and for the leg pain score, 0.1; 95% CI, -0.6 to 0.8; P = .81) or the quantitative minimum thecal sac cross-sectional area (interaction coefficients for disability score, 0.01; 95% CI, -0.01 to 0.03; P = .40; and for the leg pain score, 0.01; 95% CI, -0.01 to 0.03; P = .33). CONCLUSIONS: Imaging measures of spinal stenosis are not associated with differential clinical responses following epidural corticosteroid injection.

Factors associated with having an indication for surgery in adult spinal deformity: an international european multicentre study.

PURPOSE: The aim of this study was to evaluate factors that distinguish between patients with adult spinal deformity (ASD) with and without an indication for surgery, irrespective of their final treatment. METHODS: Baseline variables (demographics, medical history, outcome measures, coronal, sagittal and neurologic parameters) were evaluated in a multicentre, prospective cohort of patients with ASD. Multivariable analyses were carried out for idiopathic and degenerative patients separately with the dependent variable being "indication for surgery" and baseline parameters as independent variables. RESULTS: In total, 342 patients with degenerative ASD and 624 patients with idiopathic ASD were included in the multivariable models. In patients with degenerative ASD, the parameters associated with having an indication for surgery were greater self-rated disability on the Oswestry Disability Index [odds ratio (OR) 1.04, 95% confidence interval (CI) 1.02-1.07] and a lower thoracic kyphosis (OR 0.97 95% CI 0.95-0.99), whereas in patients with idiopathic ASD, it was lower (worse) SRS self-image scores (OR 0.45 95% CI 0.32-0.64), a higher value for the major Cobb angle (OR 1.03 95% CI 1.01-1.05), lower age (OR 0.96 95% CI 0.95-0.98), prior decompression (OR 3.76 95% CI 1.00-14.08), prior infiltration (OR 2.23 95% CI 1.12-4.43), and the presence of rotatory subluxation (OR 1.98 95% CI 1.11-3.54) and sagittal subluxation (OR 4.38 95% CI 1.61-11.95). CONCLUSION: Specific sets of variables were found to be associated with an indication for surgery in patients with ASD. These should be investigated in relation to patient outcomes for their potential to guide the future development of decision aids in the treatment of ASD. These slides can be retrieved under Electronic Supplementary Material.

Impact of participation in a surgical site infection surveillance network: results from a large international cohort study.

BACKGROUND: Surveillance of surgical site infections (SSIs) is a core component of effective infection control practices, though its impact has not been quantified on a large scale. AIM: To determine the time-trend of SSI rates in surveillance networks. METHODS: SSI surveillance networks provided procedure-specific data on numbers of SSIs and operations, stratified by hospitals' year of participation in the surveillance, to capture length of participation as an exposure. Pooled and procedure-specific random-effects Poisson regression was performed to obtain yearly rate ratios (RRs) with 95% confidence intervals (CIs), and including surveillance network as random intercept. FINDINGS: Of 36 invited networks, 17 networks from 15 high-income countries across Asia, Australia and Europe participated in the study. Aggregated data on 17 surgical procedures (cardiovascular, digestive, gynaecological-obstetrical, neurosurgical, and orthopaedic) were collected, resulting in data concerning 5,831,737 operations and 113,166 SSIs. There was a significant decrease in overall SSI rates over surveillance time, resulting in a 35% reduction at the ninth (final) included year of surveillance (RR: 0.65; 95% CI: 0.63-0.67). There were large variations across procedure-specific trends, but strong consistent decreases were observed for colorectal surgery, herniorrhaphy, caesarean section, hip prosthesis, and knee prosthesis. CONCLUSION: In this large, international cohort study, pooled SSI rates were associated with a stable and sustainable decrease after joining an SSI surveillance network; a causal relationship is possible, although unproven. There was heterogeneity in procedure-specific trends. These findings support the pivotal role of surveillance in reducing infection rates and call for widespread implementation of hospital-based SSI surveillance in high-income countries.

Evaluation of strategies for the treatment of type B and C pelvic fractures: results from the German Pelvic Injury Register.

Aims: The best method of treating unstable pelvic fractures that involve the obturator ring is still a matter for debate. This study compared three methods of treatment: nonoperative, isolated posterior fixation and combined anteroposterior stabilization. Patients and Methods: The study used data from the German Pelvic Trauma Registry and compared patients undergoing conservative management (n = 2394), surgical treatment (n = 1345) and transpubic surgery, including posterior stabilization (n = 730) with isolated posterior osteosynthesis (n = 405) in non-complex Type B and C fractures that only involved the obturator ring anteriorly. Calculated odds ratios were adjusted for potential confounders. Outcome criteria were intraoperative and general short-term complications, the incidence of nerve injuries, and mortality. Results: Operative stabilization reduced mortality by 36% (odds ratio (OR) 0.64, 95% confidence interval (CI) 0.42 to 0.98) but the incidence of complications was twice as high (OR 2.04, 95% CI 1.57 to 2.64). Mortality and the incidence of neurological deficits at discharge were no different after isolated posterior or combined anteroposterior fixation. However, the odds of both surgical (98%, OR 1.98, 95%CI 1.22 to 3.22) and general complications (43%, OR 1.43, 95% CI 1.02 to 2.00) were higher in the group with the more extensive surgery. Conclusion: Operative stabilization is recommended for non-complex unstable pelvic fractures. The need for anterior fixation of obturator ring fractures should, however, be considered critically. Cite this article: Bone Joint J 2018;100-B:973-83.

Temporal trends and epidemiology of Staphylococcus aureus surgical site infection in the Swiss surveillance network: a cohort study.

BACKGROUND: Staphylococcus aureus is the leading pathogen in surgical site infections (SSI). AIM: To explore trends and risk factors associated with S. aureus SSI. METHODS: Risk factors for monomicrobial S. aureus SSI were identified from the Swiss multi-centre SSI surveillance system using multi-variate logistic regression. Both in-hospital and postdischarge SSI were identified using standardized definitions. FINDINGS: Over a six-year period, data were collected on 229,765 surgical patients, of whom 499 (0.22%) developed monomicrobial S. aureus SSI; 459 (92.0%) and 40 (8.0%) were due to meticillin-susceptible S. aureus (MSSA) and meticillin-resistant S. aureus (MRSA), respectively. There was a significant decrease in the rate of MSSA SSI (P = 0.007), but not in the rate of MRSA SSI (P = 0.70). Independent protective factors for S. aureus SSI were older age [≥75 years vs <50 years: odds ratio (OR) 0.60, 95% confidence interval (CI) 0.44-0.83], laparoscopy/minimally invasive surgery (OR 0.68, 95% CI 0.50-0.92), non-clean surgery [OR 0.78 (per increase in wound contamination class), 95% CI 0.64-0.94] and correct timing of pre-operative antibiotic prophylaxis (OR 0.80, 95% CI 0.65-0.98). Independent risk factors were male sex (OR 1.38, 95% CI 1.14-1.66), higher American Society of Anesthesiologists' score (per one-point increment: OR 1.30, 95% CI 1.13-1.51), re-operation for non-infectious reasons (OR 4.59, 95% CI 3.59-5.87) and procedure type: cardiac surgery, laminectomy, and hip or knee arthroplasty had two-to nine-fold increased odds of S. aureus SSI compared with other procedures. CONCLUSIONS: SSI due to S. aureus are decreasing and becoming rare events in Switzerland. High-risk procedures that may benefit from specific preventive measures were identified. Unfortunately, many of the independent risk factors are not easily modifiable.

[The Value of Conventional Radiographs of the Pelvis in Detection of Perthes Disease 3 Months After an Episode of Acute Transient Synovitis]. / Die Wertigkeit konventioneller Röntgenaufnahmen des Beckens für die Erkennung eines Morbus Perthes 3 Monate nach durchgemachter Coxitis fugax.

Background: Transient synovitis is the most common hip joint disorder in children. Perthes disease occurs around the same age and may not be distinguishable to an episode of transient synovitis in the early stage. Therefore all children in our clinic with transient synovitis underwent a follow-up X-ray 3 months later to detect Perthes disease at an early stage. The aim of the study was to evaluate, if a follow-up X-ray is necessary for all children with suspected transient synovitis or if the clinical follow-up can lead to the indication for a follow-up X-ray. Patients and Method: Retrospective study including all children treated with the diagnosis of transient synovitis between 2004 and 2010. 198 patients with the diagnosis of a transient synovitis were included. We analyzed the radiological and clinical findings initially and after at least 3 month follow-up. Results: In the time between the episode of transient synovitis and follow-up 20 children did not remain symptom-free (10.1%). Of these patients 16 had a normal radiological follow-up and 4 (2%) were diagnosed with Perthes disease. All children which remained symptom-free between the episode of transient synovitis and the follow-up had a negative follow-up X-ray (sensitivity 0.2, specifity 1.0). Conclusion: A follow-up X-ray in detection of Perthes disease for children with transient synovitis appears to be necessary only if they have recurrent or persisting symptoms in the clinical course between the episode of transient synovitis and the 3-months-follow-up. A good patient history and an expert clinical follow-up examination are mandatory to decide whether a follow-up X-ray is needed.

[Influence of the pelvic trauma registry of the DGU on treatment of pelvic ring fractures]. / Einfluss des Beckenregisters der DGU auf die Versorgung von Beckenringfrakturen.

Fractures of the pelvic ring are comparatively rare with an incidence of 2-8 % of all fractures depending on the study in question. The severity of pelvic ring fractures can be very different ranging from simple and mostly "harmless" type A fractures up to life-threatening complex type C fractures. Although it was previously postulated that high-energy trauma was necessary to induce a pelvic ring fracture, over the past decades it became more and more evident, not least from data in the pelvic trauma registry of the German Society for Trauma Surgery (DGU), that low-energy minor trauma can also cause pelvic ring fractures of osteoporotic bone and in a rapidly increasing population of geriatric patients insufficiency fractures of the pelvic ring are nowadays observed with no preceding trauma.Even in large trauma centers the number of patients with pelvic ring fractures is mostly insufficient to perform valid and sufficiently powerful monocentric studies on epidemiological, diagnostic or therapeutic issues. For this reason, in 1991 the first and still the only registry worldwide for the documentation and evaluation of pelvic ring fractures was introduced by the Working Group Pelvis (AG Becken) of the DGU. Originally, the main objectives of the documentation were epidemiological and diagnostic issues; however, in the course of time it developed into an increasingly expanding dataset with comprehensive parameters on injury patterns, operative and conservative therapy regimens and short-term and long-term outcome of patients. Originally starting with 10 institutions, in the meantime more than 30 hospitals in Germany and other European countries participate in the documentation of data. In the third phase of the registry alone, which was started in 2004, data from approximately 15,000 patients with pelvic ring and acetabular fractures were documented. In addition to the scientific impact of the pelvic trauma registry, which is reflected in the numerous national and international publications, the dramatically changing epidemiology of pelvic ring fractures, further developments in diagnostics and the changes in operative procedures over time could be demonstrated. Last but not least the now well-established diagnostic and therapeutic algorithms for pelvic ring fractures, which could be derived from the information collated in registry studies, reflect the clinical impact of the registry.

Percutaneous screw fixation of the iliosacral joint: optimal screw pathways are frequently not completely intraosseous.

INTRODUCTION: In iliosacral screw fixation, the dimensions of solely intraosseous (secure) pathways, perpendicular to the ilio-sacral articulation (optimal) with corresponding entry (EP) and aiming points (AP) on lateral fluoroscopic projections, and the factors (demographic, anatomic) influencing these have not yet been described. METHODS: In 100 CTs of normal pelvises, the height and width of the secure and optimal pathways were measured on axial and coronal views bilaterally (total measurements: n=200). Corresponding EP and AP were defined as either the location of the screw head or tip at the crossing of lateral innominate bones' cortices (EP) and sacral midlines (AP) within the centre of the pathway, respectively. EP and AP were transferred to the sagittal pelvic view using a coordinate system with the zero-point in the centre of the posterior cortex of the S1 vertebral body (x-axis parallel to upper S1 endplate). Distances are expressed in relation to the anteroposterior distance of the S1 upper endplate (in %). The influence of demographic (age, gender, side) and/or anatomic (PIA=pelvic incidence angle; TCA=transversal curvature angle, PID-Index=pelvic incidence distance-index; USW=unilateral sacral width-index) parameters on pathway dimensions and positions of EP and AP were assessed (multivariate analysis). RESULTS: The width, height or both factors of the pathways were at least 7mm or more in 32% and 53% or 20%, respectively. The EP was on average 14±24% behind the centre of the posterior S1 cortex and 41±14% below it. The AP was on average 53±7% in the front of the centre of the posterior S1 cortex and 11±7% above it. PIA influenced the width, TCA, PID-Index the height of the pathways. PIA, PID-Index, and USW-Index significantly influenced EP and AP. Age, gender, and TCA significantly influenced EP. CONCLUSION: Secure and optimal placement of screws of at least 7mm in diameter will be unfeasible in the majority of patients. Thoughtful preoperative planning of screw placement on CT scans is advisable to identify secure pathways with an optimal direction. For this purpose, the presented methodology of determining and transferring EPs and APs of corresponding pathways to the sagittal pelvic view using a coordinate system may be useful.

Superior outcomes of decompression with an interlaminar dynamic device versus decompression alone in patients with lumbar spinal stenosis and back pain: a cross registry study.

INTRODUCTION: Surgical decompression for lumbar spinal stenosis (LSS) has been associated with poorer outcomes in patients with pronounced low back pain (LBP) as compared to patients with predominant leg pain. This cross registry study assessed potential benefits of the interlaminar coflex® device as an add-on to bony decompression alone. METHODS: Patients with lumbar decompression plus coflex® (SWISSspine registry) were compared with decompressed controls (Spine Tango registry). Inclusion criteria were LSS and a preoperative back pain level of ≥5 points. 1:1 propensity score-based matching was performed. Outcome measures were back and leg pain relief, COMI score improvement, patient satisfaction, complication, and revision rates. RESULTS: 50 matched pairs without residual significant differences but age were created. At the 7-9 months follow-up interval the coflex® group had higher back (p=0.014) and leg pain relief (p<0.001) and COMI score improvement (p=0.029) than the decompression group. Patient satisfaction was 90% in both groups. No revision was documented in the coflex® and one in the decompression group (2.0%). DISCUSSION: In the short-term, lumbar decompression with coflex® compared with decompression alone in patients with LSS and pronounced LBP at baseline is a safe and effective treatment option that appears beneficial regarding clinical and functional outcomes. However, residual confounding of non-measured covariables may have partially influenced our findings. Also, despite careful inclusion and exclusion of cases the cross registry approach introduces a potential for selection bias that we could not totally control for and that makes additional studies necessary.

Mapping tibiofemoral gonarthrosis: an MRI analysis of non-traumatic knee cartilage defects.

OBJECTIVE: Arthroscopy is "the gold standard" for the diagnosis of knee cartilage lesions. However, it is invasive and expensive, and displays all the potential complications of an open surgical procedure. Ultra-high-field MRI now offers good opportunities for the indirect assessment of the integrity and structural changes of joint cartilage of the knee. The goal of the present study is to determine the site of early cartilaginous lesions in adults with non-traumatic knee pain. METHODS: 3-T MRI examinations of 200 asymptomatic knees with standard and three-dimensional double-echo steady-state (3D-DESS) cartilage-specific sequences were prospectively studied for early degenerative lesions of the tibiofemoral joint. Lesions were classified and mapped using the modified Outerbridge and modified International Cartilage Repair Society classifications. RESULTS: A total of 1437 lesions were detected: 56.1% grade I, 33.5% grade II, 7.2% grade III and 3.3% grade IV. Cartographically, grade I lesions were most common in the anteromedial tibial areas; grade II lesions in the anteromedial L5 femoral areas; and grade III in the centromedial M2 femoral areas. CONCLUSION: 3-T MRI with standard and 3D-DESS cartilage-specific sequences demonstrated that areas predisposed to early osteoarthritis are the central, lateral and ventromedial tibial plateau, as well as the central and medial femoral condyle. ADVANCES IN KNOWLEDGE: In contrast with previous studies reporting early cartilaginous lesions in the medial tibial compartment and/or in the medial femoral condyle, this study demonstrates that, regardless of grade, lesions preferentially occur at the L5 and M4 tibial and L5 and L2 femoral areas of the knee joint.

[Complex pelvic traumas : data linkage of the German Pelvic Injury Register and the TraumaRegister DGU®]. / Das komplexe Beckentrauma : Matching des Beckenregisters DGU mit dem TraumaRegister DGU®.

BACKGROUND: Complex pelvic traumas, i.e., pelvic fractures accompanied by pelvic soft tissue injuries, still have an unacceptably high mortality rate of about 18 %. PATIENTS AND METHODS: We retrospectively evaluated an intersection set of data from the TraumaRegister DGU® and the German Pelvic Injury Register from 2004-2009. Patients with complex and noncomplex pelvic traumas were compared regarding their vital parameters, emergency management, stay in the ICU, and outcome. RESULTS: From a total of 344 patients with pelvic injuries, 21 % of patients had a complex and 79 % a noncomplex trauma. Complex traumas were significantly less likely to survive (16.7 % vs. 5.9 %). Whereas vital parameters and emergency treatment in the preclinical setting did not differ substantially, patients with complex traumas were more often in shock and showed acute traumatic coagulopathy on hospital arrival, which resulted in more fluid volumes and transfusions when compared to patients with noncomplex traumas. Furthermore, patients with complex traumas had more complications and longer ICU stays. CONCLUSION: Prevention of exsanguination and complications like multiple organ dysfunction syndrome still pose a major challenge in the management of complex pelvic traumas.

[Influencing factors on the length of stay in lumbar spine surgery : analysis of the German spine registry]. / Einflussfaktoren auf die Verweildauer in der Wirbelsäulenchirurgie : Eine Datenanalyse des Deutschen Wirbelsäulenregisters.

INTRODUCTION: Spinal disc herniation, lumbar spinal stenosis and spondylolisthesis are known to be leading causes of lumbar back pain. The cost of low back pain management and related operations are continuously increasing in the healthcare sector. There are many studies regarding complications after spine surgery but little is known about the factors predicting the length of stay in hospital. The purpose of this study was to identify these factors in lumbar spine surgery in order to adapt the postoperative treatment. MATERIAL AND METHODS: The current study was carried out as a post hoc analysis on the basis of the German spine registry. Patients who underwent lumbar spine surgery by posterior surgical access and with posterior fusion and/or rigid stabilization, whereby procedures with dynamic stabilization were excluded. Patient characteristics were tested for association with length of stay (LOS) using bivariate and multivariate analyses. RESULTS: A total of 356 patients met the inclusion criteria. The average age of all patients was 64.6 years and the mean LOS was 11.9 ± 6.0 days with a range of 2-44 days. Independent factors that were influencing LOS were increased age at the time of surgery, higher body mass index, male gender, blood transfusion of 1-2 erythrocyte concentrates and the presence of surgical complications. CONCLUSION: Identification of predictive factors for prolonged LOS may allow for estimation of patient hospitalization time and for optimization of postoperative care. In individual cases this may result of a reduction in the LOS.

[German Total Ankle Replacement Register of the German Foot and Ankle Society (D. A. F.) - presentation of design and reliability of the data as well as first results]. / Deutsches Register für Endoprothesen des oberen Sprunggelenks der Deutschen Assoziation für Fuß und Sprunggelenk e. V. - Design, Datenbelastbarkeit sowie Darstellung der 2½-Jahres-Ergebnisse.

INTRODUCTION: Even though arthroplasty of the ankle joint is considered to be an established procedure, only about 1,300 endoprostheses are implanted in Germany annually. Arthrodeses of the ankle joint are performed almost three times more often. This may be due to the availability of the procedure - more than twice as many providers perform arthrodesis - as well as the postulated high frequency of revision procedures of arthroplasties in the literature. In those publications, however, there is often no clear differentiation between revision surgery with exchange of components, subsequent interventions due to complications and subsequent surgery not associated with complications. The German Orthopaedic Foot and Ankle Association's (D. A. F.) registry for total ankle replacement collects data pertaining to perioperative complications as well as cause, nature and extent of the subsequent interventions, and postoperative patient satisfaction. MATERIAL AND METHODS: The D. A. F.'s total ankle replacement register is a nation-wide, voluntary registry. After giving written informed consent, the patients can be added to the database by participating providers. Data are collected during hospital stay for surgical treatment, during routine follow-up inspections and in the context of revision surgery. The information can be submitted in paper-based or online formats. The survey instruments are available as minimum data sets or scientific questionnaires which include patient-reported outcome measures (PROMs). The pseudonymous clinical data are collected and evaluated at the Institute for Evaluative Research in Medicine, University of Bern/Switzerland (IEFM). The patient-related data remain on the register's module server in North Rhine-Westphalia, Germany. The registry's methodology as well as the results of the revisions and patient satisfaction for 115 patients with a two year follow-up period are presented. Statistical analyses are performed with SAS™ (Version 9.4, SAS Institute, Inc., Cary, NC, USA). RESULTS: About 2½ years after the register was launched there are 621 datasets on primary implantations, 1,427 on follow-ups and 121 records on re-operation available. 49 % of the patients received their implants due to post-traumatic osteoarthritis, 27 % because of a primary osteoarthritis and 15 % of patients suffered from a rheumatic disease. More than 90 % of the primary interventions proceeded without complications. Subsequent interventions were recorded for 84 patients, which corresponds to a rate of 13.5 % with respect to the primary implantations. It should be noted that these secondary procedures also include two-stage procedures not due to a complication. "True revisions" are interventions with exchange of components due to mechanical complications and/or infection and were present in 7.6 % of patients. 415 of the patients commented on their satisfaction with the operative result during the last follow-up: 89.9 % of patients evaluate their outcome as excellent or good, 9.4 % as moderate and only 0.7 % (3 patients) as poor. In these three cases a component loosening or symptomatic USG osteoarthritis was present. Two-year follow-up data using the American Orthopedic Foot and Ankle Society Ankle and Hindfoot Scale (AOFAS-AHS) are already available for 115 patients. The median AOFAS-AHS score increased from 33 points preoperatively to more than 80 points three to six months postoperatively. This increase remained nearly constant over the entire two-year follow-up period. CONCLUSION: Covering less than 10 % of the approximately 240 providers in Germany and approximately 12 % of the annually implanted total ankle-replacements, the D. A. F.-register is still far from being seen as a national registry. Nevertheless, geographical coverage and inclusion of "high-" (more than 100 total ankle replacements a year) and "low-volume surgeons" (less than 5 total ankle replacements a year) make the register representative for Germany. The registry data show that the number of subsequent interventions and in particular the "true revision" procedures are markedly lower than the 20 % often postulated in the literature. In addition, a high level of patient satisfaction over the short and medium term is recorded. From the perspective of the authors, these results indicate that total ankle arthroplasty - given a correct indication and appropriate selection of patients - is not inferior to an ankle arthrodesis concerning patients' satisfaction and function. First valid survival rates can be expected about 10 years after the register's start.

Emergency stabilization of the pelvic ring: Clinical comparison between three different techniques.

BACKGROUND: Emergency devices for pelvic ring stabilization include circumferential sheets, pelvic binders, and c-clamps. Our knowledge of the outcome of these techniques is currently based on limited information. METHODS: Using the dataset of the German Pelvic Trauma Registry, demographic and injury-associated characteristics as well as the outcome of pelvic fracture patients after sheet, binder, and c-clamp treatment was compared. Outcome parameters included transfusion requirement of packed red blood cells, length of hospital stay, mortality, and incidence of lethal pelvic bleeding. RESULTS: Two hundred seven of 6137 (3.4%) patients documented in the German Pelvic Trauma Registry between April 30th 2004 and January 19th 2012 were treated by sheets, binders, or c-clamps. In most cases, c-clamps (69%) were used, followed by sheets (16%), and binders (15%). The median age was significantly lower in patients treated with binders than in patients treated with sheets or c-clamps (26 vs. 47 vs. 42 years, p=0.01). Sheet wrapping was associated with a significantly higher incidence of lethal pelvic bleeding compared to binder or c-clamp stabilization (23% vs. 4% vs. 8%). No significant differences between the study groups were found in sex, fracture type, blood haemoglobin concentration, arterial blood pressure, Injury Severity Score, the incidence of additional pelvic packing and arterial embolization, need of red blood cell transfusion, length of hospitalisation, and mortality. CONCLUSIONS: The data suggest that emergency stabilization of the pelvic ring by binders and c-clamps is associated with a lower incidence of lethal pelvic bleeding compared to sheet wrapping. LEVEL OF EVIDENCE: Level III.

Validity and responsiveness of the Core Outcome Measures Index (COMI) for the neck.

PURPOSE: Patient-orientated outcome questionnaires are essential to evaluate treatment success. To compare different treatments, hospitals, and surgeons, standardised questionnaires are required. The present study examined the validity and responsiveness of the Core Outcome Measurement Index for neck pain (COMI-neck), a short, multidimensional outcome instrument. METHODS: Questionnaires were completed by patients with degenerative problems of the cervical spine undergoing cervical disc arthroplasty before (N = 89) and 3 months after (N = 75) surgery. The questionnaires comprised the EuroQol-Five Dimension (EQ-5D), the North American Spine Society Cervical Spine Outcome Assessment Instrument (NASS-cervical) and the COMI-neck. RESULTS: The COMI and NASS-cervical scores displayed no notable floor or ceiling effects at any time point whereas for the EQ-5D, the highest values [corrected] were reached in around 32.5% of patients at follow-up. With one exception (symptom-specific well-being), the individual COMI items and the COMI summary score correlated to the expected extent (R = 0.4-0.8) with the scores of the chosen reference questionnaires. The area under the curve (AUC) generated by ROC analysis was significantly higher for the COMI (0.96) than for any other instrument/subscale when self reported treatment outcome was used as the external criterion, dichotomised as "good" (operation helped a lot/helped) versus "poor" (operation helped only a little/didn't help/made things worse). The COMI had a high effect size (standardised response mean; SRM) (2.34) for the good global outcome group and a low SRM for the poor outcome group (0.34). The EQ-5D and the NASS-cervical lacked this ability to differentiate between the two groups, showing less distinct SRMs for good and poor outcome groups. CONCLUSIONS: This study provides evidence that the COMI-neck is a valid and responsive questionnaire in the population of patients examined. Further investigations should examine its applicability in other patient groups with less severe neck pain or undergoing other treatment modalities.

[Acetabular fractures in the elderly. Outcome of open reduction and internal fixation]. / Osteosynthese bei Acetabulumfrakturen im Alter. Ist eine Rekonstruktion sinnvoll?

The aim of this study was to analyze the clinical outcome and incidence of hip arthritis in elderly patients with acetabular fractures. Because of poor bone quality in the elderly, even a low-energy trauma may lead to an acetabular fracture. An anatomical reconstruction of the acetabulum is necessary to achieve sufficient stability also for a potential hip arthroplasty. So far, there is very limited information on the outcome of acetabular fractures in the elderly. During a period of 6 years (2001-2006), 48 patients older than 60 years were admitted to our department with an acetabular fracture. Thirty-nine patients were treated operatively and nine patients non-operatively. Twenty-nine operatively treated patients were followed up. Nineteen of them were assessed using EQ-5D, SF-12 and Merle d'Aubigné questionnaires in addition to their clinical examination. Ten other surgical patients were only examined using the questionnaires. Of the 29 patients that were followed up, 5 underwent total hip arthroplasty due to secondary post-traumatic hip arthritis after open reduction and internal fixation (ORIF). The range of motion of the operated hip was comparable to that of the non-operated contralateral side. However, the internal rotation was found to be slightly decreased at the operated side when compared to the non-operated contralateral side. Merle d'Aubigné score and physical and mental SF-12 score components as well as quality of life were better in patients treated with ORIF compared to those patients that were treated by secondary hip arthroplasty. Regarding the different treatment strategies (ORIF vs primary hip arthroplasty vs non-operative treatment) of acetabular fractures in the elderly, data from the literature are conflicting. Our results indicate that ORIF represents a good treatment option for acetabular fractures in the elderly. In patients that did not develop secondary hip arthritis, a good clinical outcome and quality of life was documented.

Development of a documentation instrument for the conservative treatment of spinal disorders in the International Spine Registry, Spine Tango.

Spine Tango is the first and only International Spine Registry in operation to date. So far, only surgical spinal interventions have been recorded and no comparable structured and comprehensive documentation instrument for conservative treatments of spinal disorders is available. This study reports on the development of a documentation instrument for the conservative treatment of spinal disorders by using the Delphi consensus method. It was conducted with a group of international experts in the field. We also assessed the usability of this new assessment tool with a prospective feasibility study on 97 outpatients and inpatients with low back or neck pain undergoing conservative treatment. The new 'Spine Tango conservative' questionnaire proved useful and suitable for the documentation of pathologies, conservative treatments and outcomes of patients with low back or neck problems. A follow-up questionnaire seemed less important in the predominantly outpatient setting. In the feasibility study, between 43 and 63% of patients reached the minimal clinically important difference in pain relief and Core Outcome Measures Index at 3 months after therapy; 87% of patients with back pain and 85% with neck pain were satisfied with the received treatment. With 'Spine Tango conservative' a first step has been taken to develop and implement a complementary system for documentation and evaluation of non-surgical spinal interventions and outcomes within the framework of the International Spine Registry. It proved useful and feasible in a first pilot study, but it will take the experience of many more cases and therapists to develop a version similarly mature as the surgical instruments of Spine Tango.

SWISSspine: a nationwide registry for health technology assessment of lumbar disc prostheses.

SWISSspine is a so-called pragmatic trial for assessment of safety and efficiency of total disc arthroplasty (TDA). It follows the new health technology assessment (HTA) principle of "coverage with evidence development". It is the first mandatory HTA registry of its kind in the history of Swiss orthopaedic surgery. Its goal is the generation of evidence for a decision by the Swiss federal office of health about reimbursement of the concerned technologies and treatments by the basic health insurance of Switzerland. During the time between March 2005 and 2008, 427 interventions with implantation of 497 lumbar total disc arthroplasties have been documented. Data was collected in a prospective, observational multicenter mode. The preliminary timeframe for the registry was 3 years and has already been extended. Data collection happens pre- and perioperatively, at the 3 months and 1-year follow-up and annually thereafter. Surgery, implant and follow-up case report forms are administered by spinal surgeons. Comorbidity questionnaires, NASS and EQ-5D forms are completed by the patients. Significant and clinically relevant reduction of low back pain VAS (70.3-29.4 points preop to 1-year postop, p < 0.0001) leg pain VAS (55.5-19.1 points preop to 1-year postop, p < 0.001), improvement of quality of life (EQ-5D, 0.32-0.73 points preop to 1-year postop, p < 0.001) and reduction of pain killer consumption was revealed at the 1-year follow-up. There were 14 (3.9%) complications and 7 (2.0%) revisions within the same hospitalization reported for monosegmental TDA; there were 6 (8.6%) complications and 8 (11.4%) revisions for bisegmental surgery. There were 35 patients (9.8%) with complications during followup in monosegmental and 9 (12.9%) in bisegmental surgery and 11 (3.1%) revisions with 1 [corrected] new hospitalization in monosegmental and 1 (1.4%) in bisegmental surgery. Regression analysis suggested a preoperative VAS "threshold value" of about 44 points for increased likelihood of a minimum clinically relevant back pain improvement. In a short-term perspective, lumbar TDA appears as a relatively safe and efficient procedure concerning pain reduction and improvement of quality of life. Nevertheless, no prediction about the long-term goals of TDA can be made yet. The SWISSspine registry proofs to be an excellent tool for collection of observational data in a nationwide framework whereby advantages and deficits of its design must be considered. It can act as a model for similar projects in other health-care domains.

[Spinal surgery in the elderly: does age have an influence on the complication rate?]. / Wirbelsäulenchirurgie bei Patienten in höherem Lebensalter: Sind operative Eingriffe an der alternden Wirbelsäule komplikationsträchtig?

In accordance with the demographic trend, the number of elderly patients with spinal diseases which require surgery will increase continuously. Up to now, age has often been regarded as a contraindication for an elective operation. However, a review of the existing literature, the results of the European spine register "Spine Tango" and our own results show that the rate of complications after minimally invasive spinal surgery is as low in the elderly as it is in the younger population. But the higher the complexity of surgery, the higher the rate of complications with increasing age. However, even elderly (>65 years) and very elderly (>80 years) patients seem to benefit from surgical treatment, independent of the extent of spinal surgery. Because chronic pain leads to physical limitations, an impaired quality of life as well as a declined state of health, and because surgery can significantly improve these factors, even while remaining aware of the operational risks, age itself should not be considered as a contraindication for spinal surgery.