This trial aims to assess the effectiveness of quality improvement collaboratives as a technique to introduce large-scale change and improve outcomes for patients undergoing primary elective total hip or total knee arthroplasty.

41 NHS Trusts that did not have; a preoperative anaemia screening and optimisation pathways, or a methicillin sensitive Staphylococcus Aureus (MSSA) decolonisation pathway, in place were randomised to one of two parallel collaboratives in a two arm, cluster randomised controlled trial. Each collaborative focussed on implementing one of these two preoperative pathways. Collaboratives took place from May 2018 to November 2019. 27 Trusts completed the trial. Outcome data were collected for procedures between November 2018 and November 2019.

Co-primary outcomes were perioperative blood transfusion (within 7 days of surgery) and deep surgical site infections (SSI) caused by MSSA (within 90 days) for the anaemia and MSSA arms respectively. Secondary outcomes include deep and superficial SSIs (any organism), length of stay, critical care admissions, and readmissions. Process measures include the proportion of patients receiving each preoperative initiative.

19,254 procedures from 27 Trusts are included. Process measures show both preoperative pathways were implemented to a high degree (75.3% compliance in MSSA arm; 61.2% anaemia arm), indicating that QICs can facilitate change in the NHS. However, there were no improvements in blood transfusions (2.9% v 2.3% adjusted-OR 1.20, 95% CI 0.52–2.75, p=0.67), MSSA deep SSIs (0.13% v 0.14% adjusted-OR 1.01, 95%CI 0.42–2.46, p=0.98), or any secondary outcome.

Whilst no significant improvement in patient outcomes were seen, this trial shows quality improvement collaboratives can successfully support the implementation of new preoperative pathways in planned surgery in the NHS.

As a part of the European Union BIOMED I study “Assessment of Bone Quality in Osteoporosis,” Sixty-nine second lumbar vertebral body specimens (L2) were obtained post mortem from 32 women and 37 men (age 24–92 years). Our initial remit was to study variations in density of the calcified tissues by quantitative backscattered electron imaging (BSE-SEM). To this end, the para-sagittal bone slices were embedded in PMMA and block surfaces micro-milled and carbon coated. Many samples were re-polished to remove the carbon coat and stained with iodine vapour to permit simultaneous BSE imaging of non-mineralised tissues - especially disc, annulus, cartilage and ligament - uncoated, at 50Pa chamber pressure. We have now studied most of these samples by 30-μm resolution high contrast resolution X-ray microtomography (XMT), typically 72 hours scanning time, thus giving exact correlation between high resolution BSE-SEM and XMT. The 3D XMT data sets were rendered using Drishti software to produce static and movie images for visualisation and edification. We have now selected a set of the female samples for reconstruction by 3D printing - taking as examples the youngest, post-menopausal, oldest, best, worst, and anterior and central compression fractures and anterior collapse with fusion to L3 - which will be attached to the poster display. The most porotic cases were also the most difficult to reconstruct. A surprising proportion of elderly samples showed excellent bone architecture, though with retention of fewer, but more massive, load-bearing trabeculae.

Summary Statement

The structure of bone inside a porous bone graft substitute can be quantified and compared by using a combination of novel measurements of surface area and connectivity. This allows for a numerical representation of the bone structure to be calculated.

Purpose: To investigate the effect of pressurizing vertebral bodies during vertebroplasty using different materials in the development of fat embolism (FE) and any associated cardiovascular changes.

Polymethylmethacrylate (PMMA) is the material of choice for vertebroplasty (VP). However, PMMA has several disadvantages such as exothermic curing, uncertain long-term biomechanical effects and biocompatibility. As a result alternative materials are being developed to overcome these problems.

In order to determine the role of PMMA in the generation of cardiovascular changes following vertebroplasty we compared injection of cement with wax in an animal model.

Method: In twenty sheep, four vertebral bodies were augmented either with PMMA or bone wax. Heart rate, arterial, central venous and pulmonary artery pressure, cardiac output and blood gas values were recorded. At postmortem the lungs were subjected to histological evaluation.

Results: The consecutive augmentation of four vertebral bodies with PMMA induced cumulative fat embolism causing significant deterioration of baseline mean arterial blood pressure (MABP) and blood gas values. Injection of bone wax resulted in similar cardiovascular changes and amount of intravascular fat in the lungs.

Conclusion: In this animal model cardiovascular complications during multiple VP happen regardless of the augmentation material used. The deteriorating baseline MABP during VP is associated with the pressurization and displacement of bone marrow/fat into the circulation rather than caused by polymethylmethacrylate.

Introduction Polymethylmethacrylate (PMMA) has been widely used in orthopaedic procedures for fixation of joint replacements or enhancing the fixation of implants. However, the use of PMMA has been associated with cardiovascular deterioration and even death. More recently, PMMA has also been used for augmenting osteoporotic vertebral bodies which have fractured or are at risk of fracture. The main complication is PMMA leakage into adjacent structures. Transient hypotension and fatal fat embolism (FE) have also been reported.

The pathomechanism of cardiovascular deterioration after the injection of PMMA (i.e. FE) remains a highly controversial subject. The exact role of PMMA in the development of FE remains unclear. The aim of the present study was to elucidate the acute effects of injecting PMMA compared with bone wax into vertebral bodies on the cardiovascular system using an established animal model for vertebroplasty (VP) (Aebli, N, et al. Spine. 2002).

Methods In 8 skeletally mature mixed-bred ewes (2–4 years) 6.0ml PMMA (CMW3-Depuy) or bone wax (Bone Wax, Ethicon) were injected unilaterally, through an open approach into the L1 & L2 pedicles. Blood pressure, heart rate, and cardiac output were measured.

Results The major difference between the cardiovascular response of the PMMA and that of the bone wax group was the recovery in Pulmonary Artery Pressure (PAP) and Pulmonary Vascular Resistance (PVR). Three minutes post-injection, PAP had fully recovered to baseline values in the wax group. However in the PMMA group, PAP had only recovered by 52% after 3 min and fully recovered after 10 min.

Discussion The augmentation of vertebral bodies resulted in transient cardiovascular changes regardless of the material used. However, the recovery of PAP and PVR values took significantly longer with the PMMA group. The peak response was a result of pulmonary vasoconstriction triggered by a reflex reaction to the embolisation of bone marrow particles or by vasoactive cytokines. The peak response was therefore mainly associated with the increase in intraosseous pressure during the augmentation causing release of bone marrow contents into the and not the cement monomer. The cement monomer however plays a role in the cardiovascular complications during FE. The delayed recovery of PAP and PVR in the PMMA group may be due to a vasoconstriction effect of the cement monomer on the pulmonary vascular system.

Potentially serious cardiovascular complications may occur during VP regardless of the material used. The injection of PMMA may cause prolonged pulmonary hypertension during vertebro- and also arthroplasty. Continuous invasive cardiovascular monitoring may be required in patients with impaired cardiovascular and pulmonary function

Introduction and Aims: Polymethylmethacrylate (PMMA) has been widely used in orthopaedic surgery including more recently vertebroplasty. The reported rate of complications following vertebroplasty is low and mainly related to PMMA leakage.

The aim of this study was to elucidate the acute cardiovascular effects of PMMA or bone wax in a vertebroplasty animal model.

Method: Eight skeletally mature sheep were used and PMMA or bone wax were injected unilaterally into L1 and L2 at 10-minute intervals. Arterial, central venous, pulmonary artery and left ventricular pressures were recorded using Statham pressure transducers and Swan Ganz catheters were used for monitoring cardiac output.

Results: Augmentation resulted in a two-phase response regardless of which material was used. First the mean arterial blood pressures started to drop after approximately two seconds. Secondly the pulmonary artery pressure and central venous pressure increased after approximately 11 seconds, whereas cardiac output and left ventricular pressure decreased. There was no significant change in heart rate for both groups. There was a significant difference (p< 0.05) in the pulmonary artery pressure values in the PMMA group compared to the basal values at one, three and five minutes, whereas in the wax group the pulmonary artery pressure recovered within three minutes.

Conclusion: Augmentation resulted in a two-phase cardiovascular response regardless of which material was used. Peak responses were similar for both groups, but pulmonary artery pressure and cardiac output recovered quicker in the wax group. The late recovery of pulmonary artery pressure and cardiac output in the PMMA group may be due to a vasoconstriction effect of the cement monomer.

To investigate the effect of pressurizing vertebral bodies during vertebroplasty using different materials in the development of fat embolism (FE) and any associated cardiovascular changes.

Polymethylmethacrylate (PMMA) is the material of choice for vertebroplasty (VP). However, PMMA has several disadvantages such as exothermic curing, uncertain long-term biomechanical effects and biocompatibility. As a result alternative materials are being developed to overcome these problems.

In order to determine the role of PMMA in the generation of cardiovascular changes following vertebroplasty we compared injection of cement with wax in an animal model.

In twenty sheep, four vertebral bodies were augmented either with PMMA or bone wax. Heart rate, arterial, central venous and pulmonary artery pressure, cardiac output and blood gas values were recorded. At postmortem the lungs were subjected to histological evaluation.

The consecutive augmentation of four vertebral bodies with PMMA induced cumulative fat embolism causing significant deterioration of baseline mean arterial blood pressure (MABP) and blood gas values. Injection of bone wax resulted in similar cardiovascular changes and amount of intravascular fat in the lungs.

Conclusion: In this animal model cardiovascular complications during multiple VP happen regardless of the augmentation material used. The deteriorating baseline MABP during VP is associated with the pressurization and displacement of bone marrow/fat into the circulation rather than caused by polymethylmethacrylate.

Introduction: Vertebroplasty (VP) is a new prophylactic treatment for preventing osteoporotic compression fractures of vertebral bodies. During this procedure polymethylmethacrylate (PMMA) is injected into several vertebral bodies. It has been shown that fat embolism (FE) with acute cardiopulmonary deterioration occurs during VP as in a variety of other orthopaedic procedures (e.g. knee and hip replacements). The aim of the study is to investigate cardiovascular changes during FE caused by multiple VP using an animal model.

Method: In six sheep, PMMA was injected unilaterally, into L1 – L6, with ten minutes in-between injections. Arterial, venous and pulmonary artery pressure, cardiac output and blood gas values were recorded pre injection and 1, 3, 5 and 10 minutes post injection. Post mortem lungs were harvested and the histopathologic score (percentage of lung fields occupied by intravascular fat globules as seen in the microscope) was calculated.

Results: The sequential injection of bone cement into six vertebral bodies from values pre injection of L1 to 10 minutes post injection of L6 resulted in: significant falls in arterial blood pressure (P< 0.0001), cardiac output (P< 0.0001) (P=0.0049), pO₂ and pH (P< 0.0001) and significant rises in pulmonary arterial pressure (P=0.0005) and pCO₂ (P< 0.0001),but no significant change in central venous pressure. The histopathological score was 19.1±1.94%.

Conclusion: This study clearly shows that multiple VP in sheep leads to FE with major cardiovascular reactions. Arterial blood pressure showed a stepwise, cumulative fall and was clearly the best parameter to demonstrate these reactions. This suggests, in human patients, particular attention should be paid to falls in arterial blood pressure during multiple VP.

INTRODUCTION: Vertebroplasty (VP) is a new prophylactic treatment for preventing osteoporotic compression fractures of vertebral bodies. During this procedure polymethylmethacrylate (PMMA) is injected into several vertebral bodies. It has been shown that fat embolism (FE) with acute cardiopulmonary deterioration occurs during VP as in a variety of other orthopaedic procedures (eg knee and hip replacements). The aim of the study is to investigate cardiovascular changes during FE caused by multiple VP using an animal model.

METHOD: In six sheep, PMMA was injected unilaterally, into L1 – L6, with ten minutes in between injections. Arterial, venous and pulmonary artery pressure, cardiac output and blood gas values were recorded pre injection and one, three, five and 10 minutes post injection. Post mortem lungs were harvested and the histopathologic score (percentage of lung fields occupied by intravascular fat globules as seen in the microscope) was calculated.

RESULTS: The sequential injection of bone cement into six vertebral bodies from values pre injection of L1 to 10 minutes post injection of L6 resulted in: significant falls in arterial blood pressure (P< 0.0001), cardiac output (P=0.0049), pO2 (P< 0.0001) and pH (P< 0.0001) and significant rises in pulmonary arterial pressure (P=0.0005) and pCO2 (P< 0.0001), but no significant change in central venous pressure. The histopathological score was 19.1±1.94%.

CONCLUSION: This study clearly shows that multiple VP in sheep leads to FE with major cardiovascular reactions. Arterial blood pressure showed a stepwise, cumulative fall and was clearly the best parameter to demonstrate these reactions. This suggests, in human patients, particular attention should be paid to falls in arterial blood pressure during multiple VP.

Introduction: Vertebroplasty (VP) is a relatively new procedure to treat osteoporotic compression fractures of vertebral bodies. During this procedure polymethyl-methacrylate (PMMA) is injected into vertebral bodies. However there is the concern, that fat embolism (FE) and acute hypotension could occur as in a variety of other orthopaedic procedures.

Aim: To investigate whether FE and acute hypotension are potential complications of VP using an animal model.

Methods: In six sheep, 6.0 ml PMMA were injected unilaterally into the L1 vertebral body. Transœsophageal echocardiography was used to monitor the pulmonary artery for bone marrow and fat particles until 30 minutes post-operatively. Pulse, arterial and venous pressures were also recorded. The lumbar spine and the lungs were harvested post mortem. The histopathologic score, (percentage of lung fields occupied by intravascular fat globules as seen through the microscope), was calculated.

Results: The first showers of echogenic material were visible approximately seven seconds after the beginning of the cement injection and lasted for about 2.5 minutes. The injection of bone cement caused a very rapid decrease in the heart rate after two seconds followed by a fall in the mean arterial pressure after 6.0 seconds. A maximum fall in heart rate was accompanied by a delayed fall in mean arterial pressure of 33.0 mmHg (P=0.0003) at 36seconds. The heat rate had returned to the baseline by 89 seconds and had increased by 10 beats/min (P=0.02) at 25 minutes. Mean arterial pressure had recovered by 209 seconds and was not different from the baseline at 25 minutes. Post mortem examination showed that no leakage of cement into the spinal cord had occurred. The histology revealed fat globules and bone marrow cells in the smaller and larger vessels throughout the lungs. The histopathologic score was 5.2 ± 0.9%.

Conclusions: This study clearly showed that VP resulted in FE with a two-phase decrease in heart rate and arterial blood pressure. The first phase was probably due to an autonomic reflex and the second phase was due to the passage of fat emboli through the right heart and obstructing the lungs.

Introduction: Vertebroplasty (VP) is a new prophylactic treatment for preventing osteoporotic compression fractures of vertebral bodies. During this procedure polymethylmethacrylate (PMMA) is injected into several vertebral bodies. It has been shown that fat embolism (FE) with acute cardiopulmonary deterioration occurs during VP as it does in a variety of other orthopaedic procedures (e.g. knee and hip replacements).

Aim: To investigate the cardiovascular changes during FE caused by multiple VP using an animal model.

Method: PMMA was injected unilaterally, into L1 – L6 in six sheep, with 10 minutes between injections. Arterial, venous and pulmonary arterial pressure, cardiac output and blood gas values were recorded before injection and again after the injection at one, three, five and 10 minutes. The lungs were harvested post mortem and the histopathologic score (percentage of lung fields occupied by intravascular fat globules as the field of the microscope) was calculated.

Results: The sequential injection of bone cement into six vertebral bodies from values before injection of L1 to 10 minutes after injection of L6 resulted in significant falls in arterial blood pressure (P< 0.0001), cardiac output (P=0.0049), pO² (P< 0.0001) and pH (P< 0.0001). There were also significant rises in pulmonary arterial pressure (P=0.0005) and pCO2 (P< 0.0001), but no significant change in central venous pressure. The histopathological score was 19.1±1.94%,

Conclusions: This study clearly showed that multiple VP in sheep leads to FE with major cardiovascular reactions. Arterial blood pressure showed a stepwise, cumulative fall and was clearly the best parameter to demonstrate these reactions. This suggests that in human patients, particular attention should be paid to falls in arterial blood pressure during multiple VP.

Vertebroplasty (VP) is a new prophylactic treatment for preventing osteoporotic compression fractures of vertebral bodies. During this procedure polymethylmethacrylate (PMMA) is injected into several vertebral bodies. However, there is the concern, that fat embolism (FE) and acute hypotension could occur as in a variety of other orthopaedic procedures.

This study was undertaken to investigate whether FE and acute hypotension are potential complications of VP using an animal model.

In six sheep 6.0 ml PMMA were injected unilaterally into L1. Transesophageal echocardiography was used to monitor the pulmonary artery for bone marrow and fat particles until 30 minutes postoperatively. Pulse, arterial and venous pressure were also recorded. Post mortem the lumbar spine and the lungs were harvested. The lungs were subjected to histological evaluation.

The first showers of echogenic material were visible approximately 7.0 seconds after the beginning of the cement injection and lasted for about 2.5 minutes.

Injection of bone cement elicited a very rapid decrease in heart rate after 2.0 seconds followed by a fall in mean arterial pressure after 6.0 seconds. A maximum fall in heart rate was accompanied by a delayed fall in mean arterial pressure of 33.0 mmHg (P=0.0003) at 36.0 seconds. Heat rate had returned to baseline by 89.0 seconds and had increased by 10.0 beats/min (P=0.02) at 25 minutes. Mean arterial pressure had recovered by 209.0 seconds and was not different to the baseline at 25 minutes.

The post mortem inspection revealed disseminated haemorrhages on the lung surface and throughout the parenchyma mainly in the caudal lobes of all six animals. No leakage of cement into the spinal cord was detected. In histology fat globules and bone marrow cells were observed in both the smaller and larger vessels throughout the lung.

This study clearly shows that VP resulted in a two-phase decrease in heart rate and arterial blood pressure. The first phase was probably due to an autonomic reflex and the second phase was due to the passage of fat emboli through the right heart and obstructing the lungs.