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

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. © 2011 Zweig et al; licensee BioMed Central Ltd

Clinicians' and patients' views of metrics of change derived from patient reported outcome measures (PROMs) for comparing providers' performance of surgery.

BACKGROUND: Patient reported outcome measures (PROMs) are increasingly being used to compare the performance of health care providers. Our objectives were to determine the relative frequency of use of different metrics that can be derived from PROMs, explore clinicians' and patients' views of the options available, and make recommendations. METHODS: First a rapid review of the literature on metrics derived from two generic (EQ-5D and EQ-VAS) and three disease-specific (Oxford Hip Score; Oxford Knee Score; Aberdeen Varicose Vein Questionnaire) PROMs was conducted. Next, the findings of the literature review were mapped onto our typology of metrics to determine their relative frequency of use, Finally, seven group meetings with surgical clinicians (n = 107) and six focus groups with patients (n = 45) were held which were audio-taped, transcribed and analysed thematically. RESULTS: Only nine studies (9.3% of included papers) used metrics for comparing providers. These were derived from using either the follow-up PROM score (n = 3) or the change in score as an outcome (n = 5), both adjusted for pre-intervention score. There were no recorded uses of the proportion reaching a specified ('good') threshold and only two studies used the proportion reaching a minimally important difference (MID).Surgical clinicians wanted multiple outcomes, with most support expressed for the mean change in score, perceiving it to be more interpretable; there was also some support for the MID. For patients it was apparent that rather than the science behind these measures, the most important aspects were the use of language that would make the metrics personally meaningful and linking the metric to a familiar scale. CONCLUSIONS: For clinicians the recommended metrics are the mean change in score and the proportion achieving a MID, both adjusted for pre-intervention score. Both need to be clearly described and explained. For patients we recommend the proportion achieving a MID or proportion achieving a significant improvement in hip function, both adjusted for pre-intervention score

Benchmarking in the SWISSspine Registry: results of 52 Dynardi lumbar total disc replacements compared with the data pool of 431 other lumbar disc prostheses

The SWISSspine registry is the first mandatory registry of its kind in the history of Swiss orthopaedics and it follows the principle of “coverage with evidence development”. 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. Recently, developed and clinically implemented, the Dynardi total disc arthroplasty (TDA) accounted for 10% of the implanted lumbar TDAs in the registry. We compared the outcomes of patients treated with Dynardi to those of the recipients of the other TDAs in the registry. Between March 2005 and October 2009, 483 patients with single-level TDA were documented in the registry. The 52 patients with a single Dynardi lumbar disc prosthesis implanted by two surgeons (CE and OS) were compared to the 431 patients who received one of the other prostheses. Data were collected in a prospective, observational multicenter mode. Surgery, implant, 3-month, 1-year, and 2-year follow-up forms as well as comorbidity, NASS and EQ-5D questionnaires were collected. For statistical analyses, the Wilcoxon signed-rank test and chi-square test were used. Multivariate regression analyses were also performed. Significant and clinically relevant reduction of low back pain and leg pain as well as improvement in quality of life was seen in both groups (P < 0.001 postop vs. preop). There were no inter-group differences regarding postoperative pain levels, intraoperative and follow-up complications or revision procedures with a new hospitalization. However, significantly more Dynardi patients achieved a minimum clinically relevant low back pain alleviation of 18 VAS points and a quality of life improvement of 0.25 EQ-5D points. The patients with Dynardi prosthesis showed a similar outcome to patients receiving the other TDAs in terms of postoperative low back and leg pain, complications, and revision procedures. A higher likelihood for achieving a minimum clinically relevant improvement of low back pain and quality of life in Dynardi patients was observed. This difference might be due to the large number of surgeons using other TDAs compared to only two surgeons using the Dynardi TDA, with corresponding variations in patient selection, patient-physician interaction and other factors, which cannot be assessed in a registry study

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 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

Artroplastia total de disco cervical com prótese de Bryan: resultados clínicos e funcionais Artroplastía cervical total con prótesis de Bryan: resultados clínicos y funcionales Cervical total disc arthroplasty with Bryan disc: clinical and functional outcomes

OBJETIVO: Avaliar resultados da artroplastia total disco cervical com a prótese de Bryan para tratamento da cervicobraquialgia (radiculopatia) e da mielopatia compressiva. MÉTODOS: No período de 2002 a 2007, a equipe da CECOL operou 65 pacientes. Somente 28 pacientes foram localizados em 2010 para uma nova coleta de dados. Foi feita avaliação pré e pós-operatória, utilizando-se o questionário CSOQ (Cervical Spine Outcomes Questionnaire). Os critérios de Odom foram utilizados somente na avaliação pós-operatória. Ambos foram traduzidos e adaptados para cultura local. RESULTADOS: Houve melhora funcional e sintomática significativa na maioria dos pacientes. A atenuação da dor cervical (axial) e braquial (radicular) foi semelhante. Os critérios Odom indicaram 82,1% de bons e ótimos resultados, 10% satisfatórios e 7% ruins. Houve apenas uma complicação (3%), que foi revertida com a artrodese anterior. CONCLUSÕES: A artroplastia total de disco cervical demonstrou ser um método seguro e eficaz para tratamento de casos selecionados de hérnia de disco cervical associada a radiculopatia e/ou mielopatia a curto e médio prazo.<br>OBJETIVO: Evaluar los resultados de la artroplastia discal cervical con la prótesis de Bryan para el tratamiento del radiculopatía y compresión de la médula espinal (mielopatía). MÉTODOS: El equipo de CECOL ha operado 65 pacientes en el período de 2002 a 2007. Sólo 28 pacientes fueron localizados en 2010 para una nueva recolección de datos. La evaluación pre y postoperatoria se realizó mediante un cuestionario CSOQ (Cervical Spine Outcomes Questionnaire). Los criterios de Odom sólo fueron utilizados en la evaluación postoperatoria. Ambos fueron traducidos y adaptados a la cultura local. RESULTADOS: Hubo una mejora significativa sintomática y funcional en la mayoría de los pacientes. La atenuación del dolor de cuello (axial) y braquial (radicular) fue similar. Los criterios Odom demostraron 82,1% de resultados buenos y excelentes, 10% satisfactorios y el 7% malos. Hubo sólo una complicación (3%), que se revirtió con artrodesis anterior. CONCLUSIONES: La artroplastia discal cervical ha demostrado ser un método seguro y eficaz para el tratamiento de casos seleccionados de hernia de disco cervical asociada a la radiculopatía y/o a compresión de la médula espinal en el corto y mediano plazo.<br>OBJECTIVE: To evaluate results of cervical disc arthroplasty with the Bryan prosthesis for treatment of cervicobrachial pain (radiculopathy) and spinal cord compression (myelopathy). METHODS: From 2002 to 2007, the CECOL surgical staff has operated 65 patients. Only 28 patients were found in 2010 to a new data collection. The pre- and post-operative evaluation was conducted using the CSOQ questionnaire (Cervical Spine Outcomes Questionnaire). Odom criteria were used only in the postoperative evaluation. Both were translated and adapted to local culture. RESULTS: There was a significant symptomatic and functional improvement in most patients. The reduction of neck pain (axial) and brachial pain (radicular) was similar. Odom criteria showed 82.1% good and excellent results, 10% satisfactory and 7% poor. There was only one complication (3%) which was reversed with anterior arthrodesis. CONCLUSIONS: The total cervical disc arthroplasty has proved to be a safe and effective method to treat selected cases of cervical disc herniation with radiculopathy and/or myelopathy in the short and medium term