The rationale for a spine registry

In the discussion about the rationale for spine registries, two basic questions have to be answered. The first one deals with the value of orthopaedic registries per se, considering them as observational studies and comparing the evidence they generate with that of randomised controlled trials. The second question asks if the need for registries in spine surgery is similar to that in the arthroplasty sector. The widely held view that randomised controlled trials are the ‘gold standard' for evaluation and that observational methods have little or no value ignores the limitations of randomised trials. They may prove unnecessary, inappropriate, impossible, or inadequate. In addition, the external validity and hence the ability to make generalisations about the results of randomised trials is often low. Therefore, the false conflict between those who advocate randomised trials in all situations and those who believe observational data provide sufficient evidence needs to be replaced with mutual recognition of their complementary roles. The fact that many surgical techniques or technologies were introduced into the field of spine surgery without randomised trials or prospective cohort comparisons makes obvious an even increased need for spine registries compared to joint arthroplasty. An essential methodological prerequisite for a registry is a common terminology for reporting results and a sophisticated technology that networks all participants so that one central data pool is created and accessed. Recognising this need, the Spine Society of Europe has researched and developed Spine Tango, the first European spine registry, which can be accessed under www.eurospine.or

Facial, olfactory, and vocal cues to female reproductive value.

Facial, olfactory, and vocal cues may advertise women's fertility. However, most of the evidence for this proposal has come from studies of changes in young adult women's attractiveness over the menstrual cycle. By contrast with this emphasis on changes in attractiveness over the menstrual cycle, possible changes in women's attractiveness over their lifespan have received little attention. The present study investigated men's ratings of young girls' (11-15 years old), adult women's (19-30 years old) and circum-menopausal women's (50-65 years old) facial, body odor, and vocal attractiveness and femininity. Faces and voices, but not body odors, of young girls and adult women were perceived to be significantly more attractive and feminine than those of circum-menopausal women. These data suggest that facial and vocal cues may be cues to women's reproductive value, but that body odor cues do not necessarily advertise this information

A European spine registry

Abstract.: New joint replacement registries are being widely implemented across national and international organizations. The need for a continuous long-term post-market surveillance of implants has been recognized, and has become increasingly important to ensure the quality of prosthetic components. Registry data with large case numbers represent an acceptable alternative to controlled randomized clinical trials, which are often difficult to conduct in orthopedic surgery. The variety of implants and procedures in spinal surgery not only induces the same need for long-term monitoring of post-surgical product performance as in the joint replacement subspecialties, but also renders essential the establishment of a comprehensive spine registry for all major pathologies and interventions. In cooperation with the M.E. Müller Institute for Evaluative Research in Orthopedic Surgery (MEM-CED) at the University of Berne, Switzerland, the Spine Society of Europe (SSE) has launched Spine Tango: the first modular and multilevel European online registry for spinal surgery. Within Spine Tango, the major challenge in registry design and structure is the definition of and agreement upon a core set of questions as a common European dataset. Additional questions for national or individual interest can also be dynamically added to the core dataset. An automated implant tracking system has also been setup, which allows highly precise product documentation without additional work for clinical staff member

Patient characteristics differently affect early cup and stem loosening in THA: a case-control study on 7,535 patients

We postulated that certain patient characteristics have different effects on early THA component loosening. With two matched case-control studies we assessed 3,028 cups and 5,224 stems. Loosening was defined using signs of mechanical component failure on routine follow-up radiographs or revision for aseptic loosening. Women and men had similar cup-loosening odds, but women had lower odds for stem loosening (p < 0.0001). Odds for cup loosening decreased by 2.1% per additional year of age (p = 0.0004), those for stem loosening by 2.4% (p < 0.0001). Each additional kilogram of weight decreased cup loosening odds by 1.3% (p = 0.0051). Each additional unit of BMI increased stem loosening odds (p = 0.0109). Charnley classes B and C were protective factors against loosening of both components. There were no risk differences for the various main diagnoses. Certain patient characteristics differently affected early cup and stem loosening, although some characteristics had the same protective or harmful effect on component surviva

SSE Spine Tango - content, workflow, set-up: www.eurospine.org - Spine Tango

The Spine Tango registry is now accessible via the SSE webpage under www.eurospine.org - Spine Tango. Links to the Swiss/International, German and Austrian modules are provided as well as information about the philosophy, methodology and content. Following the links, the users are taken to the respective national modules for registration or log-in and data entry. The Swiss/International module, also accessible under www.spinetango.com, is used by all Swiss and international users, who do not have a separate national module. The physician administered forms for surgery, staged surgery and follow-up can be downloaded as PDFs.The officially recommended Spine Tango patient forms are also available. All forms were implemented in an online version and as scannable optical mark reader forms which can be ordered from the corresponding autho

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 3months 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 Tang

Evaluation of daily patient positioning for radiotherapy with a commercial 3D surface-imaging system (Catalyst (TM))

Background: To report our initial clinical experience with the novel surface imaging system Catalyst (TM) (C-RAD AB, Sweden) in connection with an Elekta Synergy linear accelerator for daily patient positioning in patients undergoing radiation therapy. Methods: We retrospectively analyzed the patient positioning of 154 fractions in 25 patients applied to thoracic, abdominal, and pelvic body regions. Patients were routinely positioned based on skin marks, shifted to the calculated isocenter position and treated after correction via cone beam CT which served as gold standard. Prior to CBCT an additional surface scan by the Catalyst (TM) system was performed and compared to a reference surface image cropped from the planning CT to obtain shift vectors for an optimal surface match. These shift vectors were subtracted from the vectors obtained by CBCT correction to assess the theoretical setup error that would have occurred if the patients had been positioned using solely the Catalyst (TM) system. The mean theoretical set up-error and its standard deviation were calculated for all measured fractions and the results were compared to patient positioning based on skin marks only. Results: Integration of the surface scan into the clinical workflow did not result in a significant time delay. Regarding the entire group, the mean setup error by using skin marks only was 0.0 +/- 2.1 mm in lateral, -0.4 +/- 2. 4 mm in longitudinal, and 1.1 +/- 2.6 mm vertical direction. The mean theoretical setup error that would have occurred using solely the Catalyst (TM) was -0.1 +/- 2.1 mm laterally, -1.8 +/- 5.4 mm longitudinally, and 1.4 +/- 3.2 mm vertically. No significant difference was found in any direction. For thoracic targets the mean setup error based on the Catalyst (TM) was 0.6 +/- 2.6 mm laterally, -5.0 +/- 7.9 mm longitudinally, and 0.5 +/- 3.2 mm vertically. For abdominal targets, the mean setup error was 0.3 +/- 2.2 mm laterally, 2.6 +/- 1.8 mm longitudinally, and 2.1 +/- 5.5 mm vertically. For pelvic targets, the setup error was -0.9 +/- 1.5 mm laterally, -1.7 +/- 2.8 mm longitudinally, and 1.6 +/- 2.2 mm vertically. A significant difference between Catalyst (TM) and skin mark based positioning was only observed in longitudinal direction of pelvic targets. Conclusion: Optical surface scanning using Catalyst (TM) seems potentially useful for daily positioning at least to complement usual imaging modalities in most patients with acceptable accuracy, although a significant improvement compared to skin mark based positioning could not be derived from the evaluated data. However, this effect seemed to be rather caused by the unexpected high accuracy of skin mark based positioning than by inaccuracy using the Catalyst (TM). Further on, surface registration in longitudinal axis seemed less reliable especially in pelvic localization. Therefore further prospective evaluation based on strictly predefined protocols is needed to determine the optimal scanning approaches and parameters

Tissue inhibitor of matrix metalloproteinase 1 (TIMP1) controls adipogenesis in obesity in mice and in humans

Aims/hypothesis: Extracellular matrix reorganisation is a crucial step of adipocyte differentiation and is controlled by the matrix metalloproteinase-tissue inhibitor of matrix metalloproteinase (TIMP) enzyme system. We therefore sought to define the role of TIMP1 in adipogenesis and to elucidate whether upregulation of TIMP1 in obesity has direct effects on adipocyte formation. Methods: TIMP1 protein levels and mRNA were measured in lean and obese mice with a focus on levels in adipose tissue. We also analysed the effect of recombinant murine TIMP1 on adipogenesis, adipocyte size and metabolic control in vitro and in vivo. Results: TIMP1 levels were increased in the serum and adipose tissue of obese mouse models. Recombinant murine TIMP1 inhibited adipocyte differentiation in 3T3-L1 as well as in subcutaneous primary pre-adipocytes. Conversely, neutralising TIMP1 with a specific antibody enhanced adipocyte differentiation. In vivo, injection of recombinant TIMP1 in mice challenged with a high-fat diet led to enlarged adipocytes. TIMP1-treated mice developed an impaired metabolic profile with increased circulating NEFA levels, hepatic triacylglycerol accumulation and accelerated insulin resistance. Altered glucose clearance in TIMP1-injected mice was due to changes in adipose tissue glucose uptake, whereas muscle glucose clearance remained unaffected. Conclusions/interpretation: TIMP1 is a negative regulator of adipogenesis. In vivo, TIMP1 leads to enlarged adipocytes in the state of overnutrition. This might contribute to the detrimental metabolic consequences seen in TIMP1-injected mice, such as systemic fatty acid overload, hepatic lipid accumulation and insulin resistanc

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 3years and has already been extended. Data collection happens pre- and perioperatively, at the 3months 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 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 domain