[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.

[Rotating physician in CHIR-Net. Evaluation of the curriculum]. / Als Kliniker Rotand im CHIR-Net. Evaluation des Kurrikulums.

BACKGROUND: Conduction of and participation in clinical trials is a major challenge for surgical departments especially as job performance in hospitals has increased immensely during the last few years due to economic aspects. Only 11.7 % of published clinical studies are randomized controlled trials. As more and more treatment procedures in medicine have an evidence-based design the aim must be to present randomized controlled trials with an evidence level 1 for an increasing number of surgical therapies. Since 2006 the German National Surgical Trial Network (CHIR-Net) has been established and funded by the Federal Ministry of Education and Research (BMBF) in order to promote the realization of clinical trials in surgery. Thus the basis for the execution of high quality clinical studies in surgery has been extended further. In the individual CHIR-Net centers clinical trials are planned, organized and supervised which requires extensive knowledge of prevalent international standards. Teaching them to rotating physicians is one of the tasks of CHIR-Net. Therefore, a special curriculum for physicians has been developed which is evaluated in this study. MATERIALS AND METHODS: From December 2010 to March 2011 an online survey of physicians who had previously rotated in the CHIR-Net was conducted, starting from the Surgical Regional Center (CRZ) Witten-Herdecke/Cologne. A total of 19 partly open and partly closed questions concerning the person, training, duration of the rotation, the funding applied for and the generated scientific output were surveyed. In addition, the curriculum for physicians and rotation time was checked by means of 17 questions in an evaluation matrix. RESULTS: In this article the results of the rotating physician evaluation are presented. The satisfaction of physicians with the training during the rotation is presented as well as an analysis of how many of the submitted publications were directly supported by CHIR-Net. It was also evaluated how many rotating physicians requested funding and what the type of funding was. CONCLUSION: With the rotating physician model of CHIR-Net a working concept for the training of surgeons in clinical research and the realization of randomized surgical trials was established as a viable solution for the difficult situation of clinical research in the surgical disciplines with the double burden of research and clinical practice.

Percutaneous interspinous spacer versus open decompression: a 2-year follow-up of clinical outcome and quality of life.

PURPOSE: Percutaneous interspinous stand-alone spacers offer a simple and effective technique to treat lumbar spinal stenosis with neurogenic claudication. Nonetheless, open decompressive surgery remains the standard of care. This study compares the effectiveness of both techniques and the validity of percutaneous interspinous spacer use. METHODS: Forty-five patients were included in this open prospective non-randomized study, and treated either with percutaneous interspinous stand-alone spacers (Aperius(®)) or bilateral open microsurgical decompression at L3/4 or L4/5. Patient data, operative data, COMI, SF-36, PCS and MCS, ODI, and walking distance were collected 6 weeks, 3, 6, 9, 12, and 24 months post-surgery. RESULTS: Group 1 (n = 12) underwent spacer implantation, group 2 (n = 33) open decompression. Five patients from group 1 required implant removal and open decompression during follow-up (FU); one patient was lost to FU. From group 2, seven patients were lost to FU. Remaining patients were assessed as above. After 2 years, back pain, leg pain, ODI, and quality of life improved significantly for group 2. Remaining group 1 patients (n = 6) reported worse results. Walking distance improved for both groups. CONCLUSION: Decompression proved superior to percutaneous stand-alone spacer implantation in our two observational cohorts. Therapeutic failure was too high for interspinous spacers.

The role of the inter-/supraspinous ligament complex in stand-alone interspinous process devices: a biomechanical and anatomic study.

BACKGROUND: Lumbar spinal stenosis (LSS) with neurogenic intermittent claudication is one of the most common degenerative spinal diseases in the elderly. For patients over 65 years with LSS, open decompression is the most frequent spinal surgery. One problem associated with decompression surgery is the emergence of instability, which is found in varying grades of severity. For some patients with LSS, interspinous process devices (IPD) may be a viable alternative to open decompression. The purpose of this study is to examine the destruction and changes to the interspinous and supraspinous ligament complex after percutanous IPD implantation. METHODS: Biomechanical and anatomic assessments were performed on the lumbar spine (L1-L4) of 11 fresh human cadavers. The biomechanical examination assayed the force necessary to disrupt the interspinous-supraspinous ligament complex without and after implantation of an IPD. For the anatomic examination, one lumbar spine was plastinated. Serial 4-mm thick sections were cut in sagittal and horizontal planes. The macroanatomic positioning of the implants was then analysed. RESULTS: Biomechanics: The average age of the cadavers was 80.6±10.2 years. The minimum average disrupting forces measured 313.74±113.44 N without and 239.47±63.64 N after IPD implantation, a significant (p<0.018) decrease of an average 23.7%. Anatomy: After posterolateral percutaneous IPD implantation, the posterior third of the interspinous ligament, the supraspinous ligament, the thoracolumbar fascia and paraspinous muscles bordering the inter-/supraspinous ligament complex remained undamaged. CONCLUSION: The implantation of an interspinous "stand-alone" spacer significantly minimises the force necessary to disrupt the ISL/SSL complex. After posterolateral percutaneous IPD implantation, the thoracolumbar fascia and associated musculature, which act in synergy with the ISL/SSL complex to stabilise the vertebral column, remain intact.

[Clinical research in orthopaedics--creation of a clinical trial unit in orthopaedics/trauma surgery]. / Klinische Forschung in der Orthopädie--Aufbau eines Studienzentrums in der Orthopädie/Unfallchirurgie.

AIM: The clinical trial is the link between research and medical practice and facilitates evidence-based therapies. There are specific difficulties to be faced when executing clinical trials related to surgical services (learning curve of the surgeon, blinding etc.). As a result, surgical randomised controlled clinical trials (RCT) are underrepresented in the total number of RCTs. METHOD: To make it easier to implement surgical RCT, the Clinical Trial Unit for Orthopaedics and Trauma Surgery was established. Training of the supporting physicians was reached by rotations in the structures of CHIR-Net, a BMBF-funded network created to build up a region-wide surgical research infrastructure. RESULT/CONCLUSION: Supported by the regional CHIR-Net Center and the regional Clinical Trial Center, a research institute was thus founded with the aim of contributing to a long-term improvement in clinical research in orthopaedics and trauma surgery.

[The curriculum for rotation physicians within the CHIR-Net]. / Kurrikulum für Rotationsärzte im CHIR-Net.

INTRODUCTION: CHIR-Net is a German national surgical network for clinical trials. It is supported by the Federal Ministry for Education and Research (BMBF 01GH0605) to establish infrastructure and expertise in the conduct of clinical trials within the surgical disciplines. An important aspect of this network is a qualified advanced training for physicians deployed at the CHIR-Net as part of a job rotation. METHODS: A catalog of activities for the time of rotation within the network has been developed in cooperation with the CHIR-Net, the deployed physicians and cooperating regional clinical trials centers (ZKS/KKS). RESULT: The focal points of the physicians' rotation in the CHIR-Net are outlined in a curriculum that has been established and evaluated in the network since January 2008. CONCLUSION: After the rotation time at the CHIR-Net the skilled physicians act as multipliers of specialized knowledge on clinical research. In this way the acquired expertise will be transferred into clinical practice and treatment of patients within research projects will benefit directly.

[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.