Multicenter evaluation of therapeutic strategies of inpatients with osteoporotic vertebral fractures in Germany.

PURPOSE: The aim of this study was to assess therapeutic strategies of inpatients with osteoporotic thoracolumbar fractures (OTF) in Germany. METHODS: Prospective multi-center study including 16 German-speaking trauma centers over a period of 7 months. All inpatients with OTF were included. Radiological and clinical data on admission and treatment modalities were assessed. RESULTS: Seven hundred and seven (99.3%) out of 712 included patients (73.3% female) could be evaluated. Mean age was 75 years (30-103). 51.3% could not remember any traumatic incident. Fracture distribution was from T2 to L5 with L1 (19%) most commonly affected. According to the Magerl classification type A1 (52.1%) and A3 (42.7%) were most common. B and C type injuries (2.6%) and neurological deficits (3.1%) were rare. Previous progression of vertebral deformation was evident in 34.4% of patients and related to t score below - 3 (Odds ratio 1.9661). Patients presented with anticoagulation medication (15.4%), dementia (13%), and ASA score > 3 (12.4%) frequently. 82.3% of patients complained of pain > 4 on VAS, 37% could not be mobilized despite pain medication according to grade II WHO pain ladder. 81.6% received operative treatment. Kyphoplasty (63.8%) and hybrid stabilization including kyphoplasty with (14.4%) or without screw augmentation (7.6%) were the techniques most frequently used. Invasiveness of treatment increased with degree of instability. CONCLUSIONS: OTF are mostly type A compression fractures. Patients suffer from severe pain and immobilization frequently. Progression of deformity is correlated to t score below - 3. Treatment of inpatients is mainly surgical, with kyphoplasty followed by hybrid stabilization as commonly used techniques.

OF-Pelvis classification of osteoporotic sacral and pelvic ring fractures.

OBJECTIVES: Osteoporotic fractures of the pelvis (OFP) are an increasing issue in orthopedics. Current classification systems (CS) are mostly CT-based and complex and offer only moderate to substantial inter-rater reliability (interRR) and intra-rater reliability (intraRR). MRI is thus gaining importance as a complement. This study aimed to develop a simple and reliable CT- and MRI-based CS for OFP. METHODS: A structured iterative procedure was conducted to reach a consensus among German-speaking spinal and pelvic trauma experts over 5 years. As a result, the proposed OF-Pelvis CS was developed. To assess its reliability, 28 experienced trauma and orthopedic surgeons categorized 25 anonymized cases using X-ray, CT, and MRI scans twice via online surveys. A period of 4 weeks separated the completion of the first from the second survey, and the cases were presented in an altered order. While 13 of the raters were also involved in developing the CS (developing raters (DR)), 15 user raters (UR) were not deeply involved in the development process. To assess the interRR of the OF-Pelvis categories, Fleiss' kappa (κF) was calculated for each survey. The intraRR for both surveys was calculated for each rater using Kendall's tau (τK). The presence of a modifier was calculated with κF for interRR and Cohen's kappa (κC) for intraRR. RESULTS: The OF-Pelvis consists of five subgroups and three modifiers. Instability increases from subgroups 1 (OF1) to 5 (OF5) and by a given modifier. The three modifiers can be assigned alone or in combination. In both surveys, the interRR for subgroups was substantial: κF = 0.764 (Survey 1) and κF = 0.790 (Survey 2). The interRR of the DR and UR was nearly on par (κF Survey 1/Survey 2: DR 0.776/0.813; UR 0.748/0.766). The agreement for each of the five subgroups was also strong (κF min.-max. Survey 1/Survey 2: 0.708-0.827/0.747-0.852). The existence of at least one modifier was rated with substantial agreement (κF Survey 1/Survey 2: 0.646/0.629). The intraRR for subgroups showed almost perfect agreement (τK = 0.894, DR: τK = 0.901, UR: τK = 0.889). The modifier had an intraRR of κC = 0.684 (DR: κC = 0.723, UR: κC = 0.651), which is also considered substantial. CONCLUSION: The OF-Pelvis is a reliable tool to categorize OFP with substantial interRR and almost perfect intraRR. The similar reliabilities between experienced DRs and URs demonstrate that the training status of the user is not important. However, it may be a reliable basis for an indication of the treatment score.

Recommendations for Diagnosis and Treatment of Odontoid Fractures in Geriatric Patients. / Empfehlungen zu Diagnostik und Behandlung von Frakturen des Dens axis bei geriatrischen Patienten.

BACKGROUND: Odontoid fractures in geriatric patients represent an entity of increasing incidence with a high rate of morbidity and mortality. The optimal diagnostic and therapeutic management is being controversially discussed in the literature. METHODS: In a consensus process and based on the current literature, the members of the working groups "Osteoporotic Fractures" and "Upper Cervical Spine" of the German Society for Orthopaedics and Trauma Surgery (DGOU) defined recommendations for the diagnostics and treatment of odontoid fractures in geriatric patients. RESULTS: For the diagnosis of odontoid fractures in symptomatic patients, computed tomography represents the gold standard, along with conventional radiographs. Magnetic resonance and dynamic imaging can be used as ancillary imaging modalities. With regard to fracture classification, the systems described by Anderson/D'Alonzo and by Eysel/Roosen have proved to be of value. A treatment algorithm was developed based on these classifications. Anderson/D'Alonzo type 1, type 3, and non-displaced type 2 fractures usually can be treated non-operatively. However, a close clinical and radiological follow-up is essential. In Anderson/D'Alonzo type 2 fractures, operative treatment is associated with better fracture healing. Displaced type 2 and type 3 fractures should be stabilized operatively. Type 2 fractures with suitable fracture patterns (Eysel/Roosen 2A/B) can be stabilized anteriorly. Posterior C I/II-stabilization procedures are well established and suitable for all fracture patterns.

Classification of Osteoporotic Thoracolumbar Spine Fractures: Recommendations of the Spine Section of the German Society for Orthopaedics and Trauma (DGOU).

STUDY DESIGN: Expert opinion. OBJECTIVES: Osteoporotic vertebral fractures are of increasing medical importance. For an adequate treatment strategy, an easy and reliable classification is needed. METHODS: The working group "Osteoporotic Fractures" of the Spine Section of the German Society for Orthopaedics and Trauma (DGOU) has developed a classification system (OF classification) for osteoporotic thoracolumbar fractures. The consensus decision followed an established pathway including review of the current literature. RESULTS: The OF classification consists of 5 groups: OF 1, no vertebral deformation (vertebral edema); OF 2, deformation with no or minor (<1/5) involvement of the posterior wall; OF 3, deformation with distinct involvement (>1/5) of the posterior wall; OF 4, loss of integrity of the vertebral frame or vertebral body collapse or pincer-type fracture; OF 5, injuries with distraction or rotation. The interobserver reliability was substantial (κ = .63). CONCLUSIONS: The proposed OF classification is easy to use and provides superior clinical differentiation of the typical osteoporotic fracture morphologies.

Nonsurgical and Surgical Management of Osteoporotic Vertebral Body Fractures: Recommendations of the Spine Section of the German Society for Orthopaedics and Trauma (DGOU).

STUDY DESIGN: Prospective clinical cohort study (data collection); expert opinion (recommendation development). OBJECTIVES: Treatment options for nonsurgical and surgical management of osteoporotic vertebral body fractures are widely differing. Based on current literature, the knowledge of the experts, and their classification for osteoporotic fractures (OF classification) the Spine Section of the German Society for Orthopaedics and Trauma has now introduced general treatment recommendations. METHODS: a total of 707 clinical cases from 16 hospitals were evaluated. An OF classification-based score was developed to guide in the option of nonsurgical versus surgical management. For every classification type, differentiated treatment recommendations were deduced. Diagnostic prerequisites for reproducible treatment recommendations were defined: conventional X-rays with consecutive follow-up images (standing position whenever possible), magnetic resonance imaging, and computed tomography scan. OF classification allows for upgrading of fracture severity during the course of radiographic follow-up. The actual classification type is decisive for the score. RESULTS: A score of less than 6 points advocates nonsurgical management; more than 6 points recommend surgical management. The primary goal of treatment is fast and painless mobilization. Because of expected comorbidities in this age group, minimally invasive procedures are being preferred. As a general rule, stability is more important than motion preservation. It is mandatory to restore the physiological loading capacity of the spine. If the patient was in a compensated unbalanced state at the time of fracture, reconstruction of the individual prefracture sagittal profile is sufficient. Instrumentation technique has to account for compromised bone quality. We recommend the use of cement augmentation or high purchase screws. The particular situations of injuries with neurological impairment; necessity to fuse; multiple level fractures; consecutive and adjacent fractures; fractures in ankylosing spondylitis are being addressed separately. CONCLUSIONS: The therapeutic recommendations presented here provide a reliable and reproducible basis to decide for treatment choices available. However, intermediate clinical situations remain with a score of 6 points allowing for both nonsurgical and surgical options. As a result, individualized treatment decisions may still be necessary. In the next step, the recommendations presented will be further evaluated in a multicenter controlled clinical trial.

Treatment of Fractures of the Thoracolumbar Spine: Recommendations of the Spine Section of the German Society for Orthopaedics and Trauma (DGOU).

STUDY DESIGN: consensus paper with systematic literature review. OBJECTIVE: The aim of this study was to establish recommendations for treatment of thoracolumbar spine fractures based on systematic review of current literature and consensus of several spine surgery experts. METHODS: The project was initiated in September 2008 and published in Germany in 2011. It was redone in 2017 based on systematic literature review, including new AOSpine classification. Members of the expert group were recruited from all over Germany working in hospitals of all levels of care. In total, the consensus process included 9 meetings and 20 hours of video conferences. RESULTS: As regards existing studies with highest level of evidence, a clear recommendation regarding treatment (operative vs conservative) or regarding type of surgery (posterior vs anterior vs combined anterior-posterior) cannot be given. Treatment has to be indicated individually based on clinical presentation, general condition of the patient, and radiological parameters. The following specific parameters have to be regarded and are proposed as morphological modifiers in addition to AOSpine classification: sagittal and coronal alignment of spine, degree of vertebral body destruction, stenosis of spinal canal, and intervertebral disc lesion. Meanwhile, the recommendations are used as standard algorithm in many German spine clinics and trauma centers. CONCLUSION: Clinical presentation and general condition of the patient are basic requirements for decision making. Additionally, treatment recommendations offer the physician a standardized, reproducible, and in Germany commonly accepted algorithm based on AOSpine classification and 4 morphological modifiers.

Bioceramic vertebral augmentation with a calcium sulphate/hydroxyapatite composite (Cerament SpineSupport): in vertebral compression fractures due to osteoporosis.

A prospective, non-randomized multicenter study was initiated to study efficacy and safety of a partly resorbable composite of calcium sulphate and hydroxyapatite (Cerament SpineSupport), a novel, injectable bioceramic, in osteoporotic patients with vertebral compression fractures during 18-month follow-up. Fifteen patients with low-energy trauma and 1-2 vertebral compression fractures verified by magnetic resonance imaging were recruited to undergo percutaneous bioceramic vertebral augmentation under fluoroscopy. The patients were treated with a highly flowable bioceramic containing calcium sulphate, hydroxyapatite and the non-ionic radiocontrast agent iohexol, with final setting time within 1 h. After the procedure, the patients were allowed to mobilize after 2 h. Pain (VAS), occurrence of remote and adjacent fractures, and Quality of Life (QoL; SF-36 and EQ-5D) was recorded during 18 months. The injected volume of the composite material ranged from 2.8 to 9 mL (mean 4.2 mL). Pre-operative VAS score was mean 70.3 (CI95% +/-8.7) with an immediate post-operative pain relief, which was maintained at the 4-week visit (mean 26.4 with CI95% +/-16.1) and 8-week visit (mean 18.0 with CI95% +/-13.5 pain relief). Eighty percent of the patients demonstrated a clinical improvement. The pain relief was maintained over 18 months and no adjacent fractures were observed. There was a statistically significant improvement of physical components in the QoL assessment. No extra-vertebral leakage or neurological deficits were reported in this series. This first prospective multicenter study on a partly resorbable bioceramic material indicate that fracture healing can be achieved with sustained pain relief over a follow-up period of 18 months in an osteoporotic patient population with vertebral compression fractures.

The endoscopically assisted simultaneous posteroanterior reconstruction of the thoracolumbar spine in prone position.

BACKGROUND CONTEXT: The reconstruction of the anterior column of the thoracolumbar spine has become more common in the last few years, due largely to the unfavorable results of exclusively posterior surgical treatment, which has been associated with a lack of about 10 degrees of kyphosis correction after removal of the instrumentation. The minimally invasive anterior techniques have reduced the morbidity of the anterior approach significantly. PURPOSE: A minimally invasive technique for anterior stabilization of the spine may reduce the morbidity of the open approach. Irrespective of an anterior open or an endoscopic approach, the posteroanterior instrumentation of thoracolumbar fractures requires time-consuming intraoperative maneuvers to change the patient position from prone to lateral. We describe here a standardized anterior endoscopically assisted approach for the segments T4 to L4. This approach allows the patient to remain in prone position. A 4- to 5-cm incision combined with a retractor system is used. STUDY DESIGN/SETTING: In a prospective study, all patients of our clinic who underwent surgery of the thoracolumbar spine between July 1999 and May 2001 were registered. Study criteria were duration of surgery, duration of anesthesia, intra- and postoperative complications. PATIENT SAMPLE: Between July 1999 and May 2001, 42 patients (25 male, 17 female, average age of 41.9 years), who presented with 55 injured spinal levels and underwent surgery of the thoracolumbar spine in prone position, were included. OUTCOME MEASURES: Duration of surgery (posterior/anterior/total), duration of anesthesia, method of instrumentation, intra- and postoperative complications, postoperative hospital stay and radiographs were evaluated. METHODS: Surgery was performed in prone position. A thoracic approach was used for instrumentation of T9 to L2. A retroperitoneal approach was used for stabilization of L1 to L5. Both procedures were endoscopically assisted with a new retractor system (Synframe; Synthes GmbH, Umkirch, Germany). In this manner, only an incision 4 to 5 cm long and a stab incision for the endoscope were required. The whole procedure was performed in prone position without a change of position during surgery. RESULTS: A total of 42 patients underwent surgery following this technique: 14 isolated anterior procedures (median duration of surgery, 181 minutes); 13 simultaneous one-stage procedures (median duration of surgery: 210 minutes) and 15 combined two-stage procedures (median duration of surgery: 90 minutes posterior, 120 minutes anterior, 240 minutes posterior+anterior). In the simultaneous posteroanterior procedures, the anterior instrumentation was performed 20 times using one rod, twice using two rods and in six patients simply by bone grafting. No intraoperative complications were observed. In the postoperative course, one case of pneumothorax, one case of hemothorax and one case of transient intercostal neuralgia occurred. CONCLUSION: The approach to the anterior spine in prone position is feasible by using a self-holding retractor system for the region between T4 and L4. The duration of anesthesia for the one-stage simultaneous procedure was reduced by about 40 minutes, because changing the position of the patient is no longer necessary. The minimal incision, in combination with the retractor system, significantly reduces cost by allowing the use of less expensive instruments and implants. The advantages of the open and the endoscopic techniques are combined, while their disadvantages are minimized. The main advantage of the prone position is the opportunity to access the anterior and posterior spine simultaneously, which is especially helpful in reduction maneuvers.