Management of Deep Spinal Wound Infections Following Instrumentation Surgery with Subfascial Negative Pressure Wound Therapy.

BACKGROUND AND STUDY AIMS: The treatment of infections following a spine surgery continues to be a challenge. Negative pressure wound therapy (NPWT) has been an effective method in the context of infection therapy, and its use has gained popularity in recent decades. This study aims to analyze the impact of known risk factors for postoperative wound infection on the efficiency and length of NPWT therapy until healing. PATIENTS AND METHODS: We analyzed 50 cases of NPWT treatment for deep wound infection after posterior and posteroanterior spinal fusion from March 2010 to July 2014 retrospectively. We included 32 women and 18 men with a mean age of 69 years (range, 36-87 years). Individual risk factors for postoperative infection, such as age, gender, obesity, diabetes, immunosuppression, duration of surgery, intraoperative blood loss, and previous surgeries, as well as type and onset (early vs. late) of the infection were analyzed. We assessed the associations between these risk factors and the number of revisions until wound healing. RESULTS: In 42 patients (84%), bacterial pathogens were successfully detected by means of intraoperative swabs and tissue samples during first revision. A total of 19 different pathogens could be identified with a preponderance of Staphylococcus epidermidis (21.4%) and S. aureus (19.0%). Methicillin-resistant S. aureus (MRSA) was recorded in two patients (2.6%). An average of four NPWT revisions was required until the infection was cured. Patients with infections caused by mixed pathogens required a significantly higher number of revisions (5.3 vs. 3.3; p < 0.01) until definitive wound healing. For the risk factors, no significant differences in the number of revisions could be demonstrated when compared with the patients without the respective risk factor. CONCLUSION: NPWT was an effective therapy for the treatment of wound infections after spinal fusion. All patients in the study had their infections successfully cured, and all spinal implants could be retained. The number of revisions was similar to those reported in the published literature. The present study provides insights regarding the effectiveness of NPWT for the treatment of deep wound infection after spinal fusion. Further investigations on the impact of potential risk factors for postoperative wound healing disorders are required. Better knowledge on the impact of specific risk factors will contribute to a higher effectiveness of prophylaxis for postoperative wound infections considering the patient-specific situation.

The effect of cement augmentation on pedicle screw fixation under various load cases : results from a combined experimental, micro-CT, and micro-finite element analysis.

AIMS: Anchorage of pedicle screw rod instrumentation in the elderly spine with poor bone quality remains challenging. Our study aims to evaluate how the screw bone anchorage is affected by screw design, bone quality, loading conditions, and cementing techniques. METHODS: Micro-finite element (µFE) models were created from micro-CT (µCT) scans of vertebrae implanted with two types of pedicle screws (L: Ennovate and R: S4). Simulations were conducted for a 10 mm radius region of interest (ROI) around each screw and for a full vertebra (FV) where different cementing scenarios were simulated around the screw tips. Stiffness was calculated in pull-out and anterior bending loads. RESULTS: Experimental pull-out strengths were excellently correlated to the µFE pull-out stiffness of the ROI (R2 > 0.87) and FV (R2 > 0.84) models. No significant difference due to screw design was observed. Cement augmentation increased pull-out stiffness by up to 94% and 48% for L and R screws, respectively, but only increased bending stiffness by up to 6.9% and 1.5%, respectively. Cementing involving only one screw tip resulted in lower stiffness increases in all tested screw designs and loading cases. The stiffening effect of cement augmentation on pull-out and bending stiffness was strongly and negatively correlated to local bone density around the screw (correlation coefficient (R) = -0.95). CONCLUSION: This combined experimental, µCT and µFE study showed that regional analyses may be sufficient to predict fixation strength in pull-out and that full analyses could show that cement augmentation around pedicle screws increased fixation stiffness in both pull-out and bending, especially for low-density bone. Cite this article: Bone Joint Res 2021;10(12):797-806.

Georg Schmorl Prize of the German Spine Society (DWG) 2020: new biomechanical in vitro test method to determine subsidence risk of vertebral body replacements.

PURPOSE: Prevention of implant subsidence in osteoporotic (thoraco)lumbar spines is still a major challenge in spinal surgery. In this study, a new biomechanical in vitro test method was developed to simulate patient activities in order to determine the subsidence risk of vertebral body replacements during physiologic loading conditions. METHODS: The study included 12 (thoraco)lumbar (T11-L1, L2-L4) human specimens. After dorsal stabilisation and corpectomy, vertebral body replacements (VBR) with (a) round centrally located and (b) lateral end pieces with apophyseal support were implanted, equally distributed regarding segment, sex, mean BMD ((a) 64.2 mgCaHA/cm3, (b) 66.7 mgCaHA/cm3) and age ((a) 78 years, (b) 73.5 years). The specimens were then subjected to everyday activities (climbing stairs, tying shoes, lifting 20 kg) simulated by a custom-made dynamic loading simulator combining corresponding axial loads with flexion-extension and lateral bending movements. They were applied in oscillating waves at 0.5 Hz and raised every 100 cycles phase-shifted to each other by 50 N or 0.25°, respectively. The range of motion (ROM) of the specimens was determined in all three motion planes under pure moments of 3.75 Nm prior to and after implantation as well as subsequently following activities. Simultaneously, subsidence depth was quantified from fluoroscope films. A mixed model (significance level: 0.05) was established to relate subsidence risk to implant geometries and patients' activities. RESULTS: With this new test method, simulating everyday activities provoked clinically relevant subsidence schemes. Generally, severe everyday activities caused deeper subsidence which resulted in increased ROM. Subsidence of lateral end pieces was remarkably less pronounced which was accompanied by a smaller ROM in flexion-extension and higher motion possibilities in axial rotation (p = 0.05). CONCLUSION: In this study, a new biomechanical test method was developed that simulates physiologic activities to examine implant subsidence. It appears that the highest risk of subsidence occurs most when lifting heavy weights, and into the ventral part of the caudal vertebra. The results indicate that lateral end pieces may better prevent from implant subsidence because of the additional cortical support. Generally, patients that are treated with a VBR should avoid activities that create high loading on the spine.

Implementation of an anaemia walk-in clinic: Feasibility and preliminary data from the Orthopedic University Hospital.

BACKGROUND: Approximately one in three patients suffers from preoperative anaemia. Even though haemoglobin is measured before surgery, anaemia management is not implemented in every hospital. OBJECTIVE: Here, we demonstrate the implementation of an anaemia walk-in clinic at an Orthopedic University Hospital. To improve the diagnosis of iron deficiency (ID), we examined whether reticulocyte haemoglobin (Ret-He) could be a useful additional parameter. MATERIAL AND METHODS: In August 2019, an anaemia walk-in clinic was established. Between September and December 2019, major orthopaedic surgical patients were screened for preoperative anaemia. The primary endpoint was the incidence of preoperative anaemia. Secondary endpoints included Ret-He level, red blood cell (RBC) transfusion rate, in-hospital length of stay and anaemia at hospital discharge. RESULTS: A total of 104 patients were screened for anaemia. Preoperative anaemia rate was 20.6%. Intravenous iron was supplemented in 23 patients. Transfusion of RBC units per patient (1.7 ± 1.2 vs. 0.2 ± 0.9; p = 0.004) and hospital length of stay (13.1 ± 4.8 days vs. 10.6 ± 5.1 days; p = 0.068) was increased in anaemic patients compared to non-anaemic patients. Ret-He values were significantly lower in patients with ID anaemia (33.3 pg [28.6-40.2 pg]) compared to patients with ID (35.3 pg [28.9-38.6 pg]; p = 0.015) or patients without anaemia (35.4 pg [30.2-39.4 pg]; p = 0.001). CONCLUSION: Preoperative anaemia is common in orthopaedic patients. Our results proved the feasibility of an anaemia walk-in clinic to manage preoperative anaemia. Furthermore, our analysis supports the use of Ret-He as an additional parameter for the diagnosis of ID in surgical patients.

Carbon fiber-reinforced pedicle screws reduce artifacts in magnetic resonance imaging of patients with lumbar spondylodesis.

The study investigated whether the use of carbon fiber-reinforced PEEK screw material (CF-PEEK) can reduce magnetic resonance imaging (MRI) artifact formation. Two consecutive groups of patients were treated for degenerative spinal disorders of the lumbar spine with dorsal transpedicular spinal fusion. The first group (n = 27) received titanium pedicle screws. The second group (n = 20) received CF-PEEK screws. All patients underwent an MRI assessment within the first four postoperative weeks. For each operated segment, the surface of the artifact-free vertebral body area was calculated as percentage of the total vertebral body. For each implanted segment, the assessability of the spinal canal, the neuroforamina, and the pedicle screws, as well as the surrounding bony and soft-tissue structures was graded from 1 to 5. A mean artifact-free vertebral body area of 48.3 ± 5.0% was found in the in the titanium group and of 67.1 ± 5.6% in the CF-PEEK group (p ≤ 0.01). Assessability of the lumbar spine was significantly improved for CF-PEEK screws (p ≤ 0.01) for all measurements. CF-PEEK pedicle screws exhibit smaller artifact areas on vertebral body surfaces and their surrounding tissues, which improves the radiographic assessability. Hence, CF-PEEK may provide a diagnostic benefit.

Adrenoceptor Expression during Intervertebral Disc Degeneration.

Healthy and degenerating intervertebral discs (IVDs) are innervated by sympathetic nerves, however, adrenoceptor (AR) expression and functionality have never been investigated systematically. Therefore, AR gene expression was analyzed in both tissue and isolated cells from degenerated human IVDs. Furthermore, human IVD samples and spine sections of wildtype mice (WT) and of a mouse line that develops spontaneous IVD degeneration (IVDD, in SM/J mice) were stained for ARs and extracellular matrix (ECM) components. In IVD homogenates and cells α1a-, α1b-, α2a-, α2b-, α2c-, ß1-, and ß2-AR genes were expressed. In human sections, ß2-AR was detectable, and its localization parallels with ECM alterations. Similarly, in IVDs of WT mice, only ß2-AR was expressed, and in IVDs of SM/J mice, ß2AR expression was stronger accompanied by increased collagen II, collagen XII, decorin as well as decreased cartilage oligomeric matrix protein expression. In addition, norepinephrine stimulation of isolated human IVD cells induced intracellular signaling via ERK1/2 and PKA. For the first time, the existence and functionality of ARs were demonstrated in IVD tissue samples, suggesting that the sympathicus might play a role in IVDD. Further studies will address relevant cellular mechanisms and thereby help to develop novel therapeutic options for IVDD.

A Prospective, Randomized Study Evaluating Clinical and Radiographic Efficacy of Lumbar Interbody Fusion Performed Using a Truss Technology-Based Interbody Fusion Device With Homologous Bone or Bone Marrow Aspirate.

BACKGROUND: Our group used vertebral bone marrow aspirate (BMA) with an anterior truss-based interbody implant to promote fusion. This implant has biomechanical characteristics that may enhance bone on-growth and through-growth and allow for the use of BMA clot alone. The primary end point was comparison of the proportion of patients who achieved fusion with the implant packed with either crushed cancellous homologous bone chips (CCB) alone or with BMA clot alone. METHODS: Patients were randomized to receive either BMA clot or CCB in the implant. Both groups also had supplemental fixation. Clinical assessments were performed preoperatively and postoperatively at 3, 6, and 12 months, including for the Oswestry Disability Index, leg and back visual analog scale, EQ5-D, reoperations, complications, and adverse events. Radiographs were obtained prior to discharge and at 3, 6, and 12 months postoperatively. A computed tomography scan was performed 3 months postoperatively. Radiographs were assessed by an independent radiologist to determine fusion status and evidence of subsidence. RESULTS: Between January 2015 and February 2016, 42 consecutive patients were randomized into 1 of the 2 study groups. There were significant postoperative changes within both groups in pain improvement across all outcome scales. There were no significant differences between groups in change scores from preoperative to assessments at any follow-up time point, with the exception of the change in EQ-5D and visual analog scale at 6 months; however, there was no difference at 3 or 12 months. There were no device-related adverse events in either group. All patients achieved grade II fusion at 3 months postoperatively. There was no significant difference in implant subsidence between groups or smokers versus nonsmokers. CONCLUSIONS: The clinical outcomes of this study suggest that reliable fusion can be obtained using an anterior truss-based implant with either CCB or BMA alone. LEVEL OF EVIDENCE: 2.

Clinical Outcome After Anterior Lumbar Interbody Fusion With a New Osteoinductive Bone Substitute Material: A Randomized Clinical Pilot Study.

STUDY DESIGN: Pilot, single-center, single-blinded, parallel-group, randomized clinical study. OBJECTIVE: The aim of this study was to pilot a randomized clinical study to evaluate whether instrumented anterior lumbar interbody fusion (ALIF) with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2) leads to superior radiologic and clinical outcomes at 12-month follow-up compared with instrumented ALIF with homologous bone. SUMMARY OF BACKGROUND DATA: ALIF completed with interbody cages is an established technique for performing arthrodesis of the lumbar spine. There is ongoing discussion about which cage-filling material is most appropriate. This is the first study to assess the efficacy of NH-SiO2 in ALIF surgery. MATERIALS AND METHODS: This randomized, clinical, pilot trial included 2 groups of 20 patients with monosegmental or multisegmental degenerative disease of the lumbar spine who were suitable to undergo monosegmental or bisegmental ALIF fusion at the level L4/L5 and L5/S1 with a carbon fiber reinforced polymer ALIF cage filled with either NH-SiO2 or homogenous bone. Primary outcome was postoperative disability as measured by the Oswestry Disability Index (ODI). Secondary outcomes were postoperative radiographic outcomes, pain, and quality of life. Patients were followed 12 months postoperatively. RESULTS: Mean (±SD) 12-month ODI was 24±17 in the NH-SiO2 group and 27±19 in the homologous bone group (P=0.582). Postoperative radiography, functional outcomes, and quality-of-life indices did not differ significantly between groups at any of the regularly scheduled follow-up visits. CONCLUSIONS: This clinical study showed similar functional, radiologic, and clinical outcomes 12 months postoperatively for instrumented ALIF procedures with the use of NH-SiO2 or homologous bone as cage filling. In the absence of any relevant differences in outcome, we postulate that the pivotal clinical study should be designed as an equivalence trial.

Radiological evaluation of kyphoplasty with an intravertebral expander after osteoporotic vertebral fracture.

Spinal deformities due to osteoporotic vertebral compression fractures can be reduced by balloon kyphoplasty, but the correction may be partly lost when the balloon is deflated. The present study aimed to evaluate an intravertebral expander developed to reduce and maintain vertebral body height while cement is injected to correct spinal deformities due to osteoporotic vertebral fractures. The study included 31 osteoporotic vertebral body fractures in 31 patients, classified as A1 according to the AO classification, who underwent kyphoplasty using an intravertebral expander. The kyphosis angle was significantly corrected from 13.4 degrees prior to kyphoplasty to 10.8 degrees (p < 0.01) after surgery, but this correction was lost at 12 months (13.3 degrees). The correction of the kyphosis angle best correlated with the pre-operative mobility of the fracture (r = 0.59, p < 0.01), and the loss of the kyphosis improvement correlated with the amount of correction (r = 0.49, p = 0.01). All patients, except for six with adjacent vertebral fractures, experienced significant pain reduction (VAS 8.7 pre-operatively and 2.0 at 12 months; p < 0.01), and the pain was not affected by the correction of the spinal deformity or the loss of correction in the follow-up period. These results suggest that the mobility of the fracture mainly determines the extent of deformity correction rather the device used for reduction, and greater corrections are at increased risk for losing the improvement. © 2018 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 37:457-465, 2019.

Anterior cement augmentation of adjacent levels after vertebral body replacement leads to superior stability of the corpectomy cage under cyclic loading-a biomechanical investigation.

BACKGROUND: In the operative treatment of osteoporotic vertebral body fractures, a dorsal stabilization in combination with a corpectomy of the fractured vertebral body might be necessary with respect to the fracture morphology, whereby the osteoporotic bone quality may possibly increase the risk of implant failure. To achieve better stability, it is recommended to use cement-augmented screws for dorsal instrumentation. Besides careful end plate preparation, cement augmentation of the adjacent end plates has also been reported to lead to less reduction loss. PURPOSE: The aim of the study was to evaluate biomechanically under cyclic loading whether an additional cement augmentation of the adjacent end plates leads to improved stability of the inserted cage. STUDY DESIGN/SETTING: Methodical cadaver study. MATERIALS AND METHODS: Fourteen fresh frozen human thoracic spines with proven osteoporosis were used (T2-T7). After removal of the soft tissues, the spine was embedded in Technovit (Kulzer, Germany). Subsequently, a corpectomy of T5 was performed, leaving the dorsal ligamentary structures intact. After randomization with respect to bone quality, two groups were generated: Dorsal instrumentation (cemented pedicle screws, Medtronic, Minneapolis, MN, USA)+cage implantation (CAPRI Corpectomy Cage, K2M, Leesburg, VA, USA) without additional cementation of the adjacent endplates (Group A) and dorsal instrumentation+cage implantation with additional cement augmentation of the adjacent end plates (Group B). The subsequent axial and cyclic loading was performed at a frequency of 1 Hz, starting at 400 N and increasing the load within 200 N after every 500 cycles up to a maximum of 2,200 N. Load failure was determined when the cages sintered macroscopically into the end plates (implant failure) or when the maximum load was reached. RESULTS: One specimen in Group B could not be clamped appropriately into the test bench for axial loading because of a pronounced scoliotic misalignment and had to be excluded. The mean strength for implant failure was 1,000 N±258.2 N in Group A (no cement augmentation of the adjacent end plates, n=7); on average, 1,622.1±637.6 cycles were achieved. In Group B (cement augmentation of the adjacent end plates, n=6), the mean force at the end of loading was 1,766.7 N±320.4 N; an average of 3,572±920.6 cycles was achieved. Three specimens reached a load of 2,000 N. The differences between the two groups were significant (p=.006 and p=.0047) regarding load failure and number of cycles. CONCLUSIONS: Additional cement augmentation of the adjacent end plates during implantation of a vertebral body replacement in osteoporotic bone resulted in a significant increased stability of the cage in the axial cyclic loading test.

[Current Status of Spine Surgery in Germany: Results of a Survey of Members of the German Spine Society]. / Aktueller Status der Wirbelsäulenchirurgie in Deutschland ­ Ergebnisse einer Umfrage unter Mitgliedern der Deutschen Wirbelsäulengesellschaft.

Background Mono- (MSS) and bisegmental spinal fusion (BSS) are frequently performed surgical interventions in German hospitals. Despite the high number of cases, only few data on treatment procedures and concepts for pre-, peri-, and postoperative care are available. The aim of the survey was to gain detailed insights into treatment procedures and medical approaches in elective MSS and BSS care in Germany in order to extract recommendations for improving patient care. Materials and Methods Members of the German Spine Society (DWG) were sent a newsletter, inviting them to participate in a survey; 209 senior physicians agreed to do so. They were asked about length of stay (LOS), care concepts and outcome measurement. Results The data from 142 completed questionnaires were used in the analysis. In some aspects, there was a consistency in practice: preoperative patient information about the care process and discharge on the basis of qualitative criteria. However, there was also considerable variability in practice: in rehabilitation, restrictions, radiological control, pre- and postoperative outcome measurement and interdisciplinary coordination. Conclusion More than half of the surveyed physicians declared that they followed a structured care plan. However, the treatment procedures in MSS and BSS care are very heterogeneous in German hospitals. It also became clear that this is particularly pronounced in aspects of treatment for which evidence is lacking. The results give important indications regarding aspects of treatment procedures and organizational structures that can be optimized for better patient care.

Small cavity creation in the vertebral body reduces the rate of cement leakage during vertebroplasty.

Cement leakage is the most common complication during vertebroplasty and may result in serious morbidity. Measures to reduce the rate of cement leakage are valuable ways to improve vertebroplasty safety. The present study aimed to evaluate whether creating a small cavity in the vertebral body prior to cement injection would reduce the rate of cement leakage during vertebroplasty. The study included 36 consecutive patients with 42 painful osteoporotic vertebral body compression fractures that were classified as A1 fractures according to AO classification. Patients were randomly assigned to receive either treatment with vertebroplasty (control) or with a procedure termed cavuplasty, in which a small cavity was created in the vertebral body prior to cement injection. CT scanning was performed to detect cement leakage. Cement leakage was observed in 14 (66.6%) of the 21 vertebral bodies treated with vertebroplasty and 5 (23.8%) of the 21 vertebral bodies treated with cavuplasty (p = 0.012). These results suggest that the creation of a small cavity in the vertebral body prior to cement injection is an effective way to reduce cement leakage during vertebroplasty. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:154-159, 2017.