Research quality and transparency, outcome measurement and evidence for safety and effectiveness in robot-assisted surgery: systematic review.

BACKGROUND: Robot-assisted surgery (RAS) has potential panspecialty surgical benefits. High-quality evidence for widespread implementation is lacking. This systematic review aimed to assess the RAS evidence base for the quality of randomized evidence on safety and effectiveness, specialty 'clustering', and outcomes for RAS research. METHODS: A systematic review was undertaken according to PRISMA guidelines. All pathologies and procedures utilizing RAS were included. Studies were limited to RCTs, the English language and publication within the last decade. The main outcomes selected for the review design were safety and efficacy, and study purpose. Secondary outcomes were study characteristics, funding and governance. RESULTS: Searches identified 7142 titles, from which 183 RCTs were identified for data extraction. The commonest specialty was urology (35·0 per cent). There were just 76 unique study populations, indicating significant overlap of publications; 103 principal studies were assessed further. Only 64·1 per cent of studies reported a primary outcome measure, with 29·1 per cent matching their registration/protocol. Safety was assessed in 68·9 per cent of trials; operative complications were the commonest measure. Forty-eight per cent of trials reported no significant difference in safety between RAS and comparator, and 11 per cent reported RAS to be superior. Efficacy or effectiveness was assessed in 80·6 per cent of trials; 43 per cent of trials showed no difference between RAS and comparator, and 24 per cent reported that RAS was superior. Funding was declared in 47·6 per cent of trials. CONCLUSION: The evidence base for RAS is of limited quality and variable transparency in reporting. No patterns of harm to patients were identified. RAS has potential to be beneficial, but requires continued high-quality evaluation.

Arthroscopic meniscal surgery: a national society treatment guideline and consensus statement.

AIMS: The aim of the British Association for Surgery of the Knee (BASK) Meniscal Consensus Project was to develop an evidence-based treatment guideline for patients with meniscal lesions of the knee. MATERIALS AND METHODS: A formal consensus process was undertaken applying nominal group, Delphi, and appropriateness methods. Consensus was first reached on the terminology relating to the definition, investigation, and classification of meniscal lesions. A series of simulated clinical scenarios was then created and the appropriateness of arthroscopic meniscal surgery or nonoperative treatment in each scenario was rated by the group. The process was informed throughout by the latest published, and previously unpublished, clinical and epidemiological evidence. Scenarios were then grouped together based upon the similarity of clinical features and ratings to form the guideline for treatment. Feedback on the draft guideline was sought from the entire membership of BASK before final revisions and approval by the consensus group. RESULTS: A total of 45 simulated clinical scenarios were refined to five common clinical presentations and six corresponding treatment recommendations. The final guideline stratifies patients based upon a new, standardized classification of symptoms, signs, radiological findings, duration of symptoms, and previous treatment. CONCLUSION: The 2018 BASK Arthroscopic Meniscal Surgery Treatment Guidance will facilitate the consistent identification and treatment of patients with meniscal lesions. It is hoped that this guidance will be adopted nationally by surgeons and help inform healthcare commissioning guidance. Validation in clinical practice is now required and several areas of uncertainty in relation to treatment should be a priority for future high-quality prospective studies. Cite this article: Bone Joint J 2019;101-B:652-659.

Rates of knee arthroplasty within one-year of undergoing arthroscopic partial meniscectomy in England: temporal trends, regional and age-group variation in conversion rates.

OBJECTIVE: The aim of this study was to determine the proportion of patients undergoing arthroscopic partial meniscectomy (APM) then subsequently receiving a knee arthroplasty within one or two years, with focus on patients over the age of 60 years and regional variation. METHODS: Patients undergoing APM in England over 20-years (01-April-1997 to 31-March 2017) were identified in the national Hospital Episode Statistics (HES). The proportion of patients undergoing arthroplasty in the same knee within one or two years of APM was determined and trends were analysed over time nationally and by NHS Clinical Commissioning Group (CCG) region. RESULTS: 806,195 APM patients were eligible for analysis with at least one-year of follow up and 746,630 with two-years. The odds of arthroplasty conversion within one year increased over the study period (odds ratio [OR] 3.10 within 1-year in 2014 vs 2000; 95% confidence interval [CI] 2.75-3.50). For patients undergoing APM aged 60 years or older in 2015-16, 9.9% (1689/17,043; 95% CI 9.5-10.4) underwent arthroplasty within 1-year and, in 2014-15, 16.6% (3100/18,734; 95% CI 16.0-17.1) underwent arthroplasty within 2-years. There was greater than 10-fold variation by CCG. CONCLUSIONS: Over the study period, the proportion of patients undergoing arthroplasty within one-year of APM increased. In 2015-16, of patients aged 60 years or older who underwent APM, 10% subsequently underwent knee arthroplasty within one year (17% within two years in 2014-15) and there was a high level of regional variation in this outcome. The development and adoption of national treatment guidance is recommended to improve and standardise treatment selection.

Outcome-based commissioning of knee arthroplasty in the NHS: system error in a national monitoring programme and the unintended consequences on achieving the Best Practice Tariff.

AIMS: Our unit was identified as a negative outlier in the national patient-reported outcome measures (PROMs) programme, which has significant funding implications. As a centre that carries out a high volume of unicompartmental knee arthroplasty (UKA), our objectives were: 1) to determine whether the PROMs programme included primary UKA when calculating the gain in Oxford Knee Score (OKS); and 2) to determine the impact of excluding primary UKA on calculated OKS gains for primary knee arthroplasty. MATERIALS AND METHODS: National PROMs data from England (2012 to 2016) were analyzed. Inclusion of UKA cases in the national PROMs programme was determined using clinical codes. Local OKS gain was calculated for UKA and TKA and compared with the published PROMs results for 2012/13. RESULTS: Use of the recommended codes for primary UKA excluded 99.6% of UKAs locally and 97% nationally from PROMs programme analysis. Inclusion of primary UKAs in PROMs analysis improved our OKS gain from 15.1 (below average) to 16.3 (above average) for 2012/13 for primary knee arthroplasty. CONCLUSION: Exclusion of UKA patients from the PROMs programme is a nationwide issue that potentially introduces bias when comparing OKS gain between centres. Where commissioning decisions are based on routinely collected data, it is imperative that the underlying methodology is appropriate to generate valid results.

National consensus on the definition, investigation, and classification of meniscal lesions of the knee.

BACKGROUND: The aim of this study was to deliver standardised terminology for the identification and stratification of patients with meniscal lesions of the knee. METHODS: A national group of expert surgeons was convened by the British Association for Surgery of the Knee (BASK) and a formal consensus process was undertaken following a validated methodology. A combination of nominal group techniques and an iterative Delphi process was used to develop and refine relevant definitions. Where appropriate, definitions were placed into categories to facilitate use in clinical practice and guideline development. RESULTS: A degenerative meniscus develops progressively with degradation of meniscal tissue and this may be revealed by intra-meniscal high signal on magnetic resonance imaging (MRI). A meniscal tear was defined as a defect or split in the meniscocapsular complex, which can occur in a degenerative or non-degenerative meniscus. Degenerative meniscal lesions (high signal or tear) are frequent in the general population and are often incidental findings on knee MRI. Symptoms were defined and classified into three groups: (1) strongly suggestive of a treatable meniscal lesion, (2) potentially suggestive of a treatable meniscal lesion, (3) osteoarthritic. A strategy for radiological imaging (radiograph ±â€¯MRI) was agreed for the investigation of the patients with a possible meniscal tear. Meniscal lesions and tear patterns on MRI imaging were defined and classified with reference to potential treatability: (1) target, (2) possible target, (3) no target. CONCLUSIONS: The agreed terminology will enable patients with meniscal lesions to be identified and stratified consistently in clinical practice, research and guideline development.

Synthesis, characterization, antibacterial activity and cytotoxicity of hollow TiO2-coated CeO2 nanocontainers encapsulating silver nanoparticles for controlled silver release.

Biomaterials as implants are being applied more extensively in medicine due to their on-going development and associated improvements, and the increase in human life expectancy. Nonetheless, biomaterial-related infections, as well as propagating bacterial resistance, remain significant issues. Therefore, there is a growing interest for silver-based drugs because of their efficient and broad-range antimicrobial activity and low toxicity to humans. Most newly-developed silver-based drugs have an extremely fast silver-ion release, increasing adverse biological impact to the surrounding tissue and achieving only short-term antimicrobial activity. Nanoencapsulation of these drugs is hypothesized as beneficial for controlling silver release, and thus is the aim of the present study. Initially, an amorphous or crystalline (anatase) titania (TiO2) coating was synthesized around silver nanoparticle-containing (AgNP) ceria (CeO2) nanocontainers using a sonication method forming AgNP/CeO2/TiO2 nanocontainers. These nanocontainers were characterized by high-resolution transmission electron microscopy, scanning electron microscopy, powder X-ray diffraction, gas sorption experiments and energy-dispersive X-ray spectroscopy. Silver release, monitored by using inductively coupled plasma optical emission spectroscopy, showed that these containers prevented silver release in water at neutral pH, and released the silver in concentrated nitric acid solution (pH = 1.1). The AgNP/CeO2/TiO2 nanocontainers showed an antibacterial activity against E. coli, however a concentration-dependent cytotoxicity towards a model epithelial barrier cell type (A549 cells) was observed. These nanocontainers offer the concept of potentially controlling silver delivery for the prevention of implant-associated infections.

Outcomes of 807 Thompson hip hemiarthroplasty procedures and the effect of surgical approach on dislocation rates.

The majority of displaced intracapsular fractures in our unit are managed with a Thompson hip hemiarthroplasty. Recent UK guidance from the National Institute for Health and Care Excellence has, however, advised against the continued used of the Thompson implant in patients with hip fracture. The aim of this study was to review the outcomes and complications after Thompson hip hemiarthroplasty, including the impact of modern surgical approaches and cementing, whilst controlling for confounding factors. We reviewed the outcomes following Thompson hip hemiarthroplasty from a series of 807 cases performed between April 2008 and November 2013. Of these, 721 (89.3%) were cemented and 86 (10.7%) uncemented. A total of 575 (71.3%) procedures were performed in female patients. The anterolateral approach was performed in 753 (93.3%) and the posterior approach with enhanced soft tissue repair in 54 (6.7%). Overall, there were 23 dislocations (2.9%). Dislocation following the posterior approach occurred in 13.0% (seven of 54) in comparison to 2.1% (16 of 753) with the anterolateral approach (odds ratio (OR) 8.5 (95% confidence interval (CI) 2.8-26.3), p < 0.001). Patients were discharged home in 459 cases (56.9%), to a care home or other hospital in 273 cases (33.8%). Of the total number of patients, 75 died during their admission (9.3%), and 51.8% (338 of 653) returned home within 30 days. The 30-day mortality was 7.1% (57 cases) and the 1-year mortality was 16.6% (116 of 699). We recommend against the continued use of the posterior approach in hip hemiarthroplasty, as enhanced soft tissue repair did not reduce the dislocation rates to an acceptable level in this series utilising the Thompson implant. Our findings, however, demonstrate satisfactory results for patients treated with the Thompson hip hemiarthroplasty performed through an anterolateral approach. We suggest that the continued use of this implant in a carefully selected patient cohort is justifiable.

The long-term outcome of uncemented Low Contact Stress total knee replacement in patients with rheumatoid arthritis: results at a mean of 22 years.

We reviewed the long-term clinical and radiological results of 63 uncemented Low Contact Stress (LCS) total knee replacements (TKRs) in 47 patients with rheumatoid arthritis. The mean age of the patients at the time of surgery was 69 years (53 to 81). At a mean follow-up of 22 years (20 to 25), 12 patients were alive (17 TKRs), 27 had died (36 TKRs), and eight (ten TKRs) were lost to follow-up. Revision was necessary in seven patients (seven TKRs, 11.1%) at a mean of 12.1 years (0 to 19) after surgery. In the surviving ten patients who had not undergone revision (15 TKRs), the mean Oxford knee score was 30.2 (16 to 41) at a mean follow-up of 19.5 years (15 to 24.7) and mean active flexion was 105° (90° to 150°). The survival rate was 88.9% at 20 years (56 of 63) and the Kaplan-Meier survival estimate, without revision, was 80.2% (95% confidence interval 37 to 100) at 25 years.

Inadequate 'three-point' proximal fixation predicts failure of the Gamma nail.

The Gamma nail is frequently used in unstable peri-trochanteric hip fractures. We hypothesised that mechanical failure of the Gamma nail was associated with inadequate proximal three-point fixation. We identified a consecutive series of 299 Gamma nails implanted in 299 patients over a five-year period, 223 of whom fulfilled our inclusion criteria for investigation. The series included 61 men and 162 women with a mean age of 81 years (20 to 101). Their fractures were classified according to the Modified Evans' classification and the quality of fracture reduction was graded. The technical adequacy of three points of proximal fixation was recorded from intra-operative fluoroscopic images, and technical inadequacy for each point was defined. All patients were followed to final follow-up and mechanical failures were identified. A multivariate statistical analysis was performed, adjusting for confounders. A total of 16 failures (7.2%) were identified. The position of the lag screw relative to the lateral cortex was the most important point of proximal fixation, and when inadequate the failure rate was 25.8% (eight of 31: odds ratio 7.5 (95% confidence interval 2.5 to 22.7), p < 0.001). Mechanical failure of the Gamma nail in peri-trochanteric femoral fractures is rare (< 1%) when three-point proximal fixation is achieved. However, when proximal fixation is inadequate, failure rates increase. The strongest predictor of failure is positioning the lateral end of the lag screw short of the lateral cortex. Adherence to simple technical points minimises the risk of fixation failure in this vulnerable patient group.

The effects of introducing artemether-lumefantrine malaria treatment and insecticide-impregnated bed nets to an elective surgical hospital.

Malaria and anaemia in patients admitted for elective orthopaedic operations commonly cause delays to surgery. Our hospital has introduced artemether-lumefantrine as the standard treatment for malaria in accordance with the national policy, replacing sulphadoxine-pyrimethamine. Insecticide-impregnated bed nets were also introduced throughout our wards. A retrospective audit of all new elective surgical admissions over a 12-month period was performed in order to assess the effect of these changes. The study was designed to follow an identical audit performed before their introduction. Of the 435 patients admitted, 75 (17.2%) had malaria parasites present on blood film. In these patients, surgery was significantly delayed, by a mean of 9.9 days more than the group without malaria (P < 0.001). Before the changes to malaria treatment, the mean delay was 2.2 days (P < 0.05). Six patients (1.7%) developed malaria during admission, significantly fewer than the 16 (4.3%) before the introduction of bed nets (P = 0.036). The average haemoglobin level on admission in patients with malaria parasites was 11.8 g/dL (95% confidence interval [CI] 11.4-12.2) and in those without 13.1 g/dL (95% CI: 12.9-13.3). Seventeen patients (3.9%) were admitted with a haemoglobin concentration of <10 g/dL and two (0.5%) of <8 g/dL. There were no significant delays to surgery in these patients compared to those without anaemia. The adoption of artemether-lumefantrine by our hospital significantly increased delays to surgery. The introduction of insecticide-impregnated bed nets significantly reduced the number of patients developing malaria during their hospital stay.

Routine spinal immobilization in trauma patients: what are the advantages and disadvantages?

Routine spinal immobilization for trauma patients has become established in developed countries throughout the world. Cervical spinal injury is, however, relatively rare in trauma patients, and immobilization practice was developed largely without firm supporting evidence. In recent years, published evidence has suggested that spinal immobilization may in some cases be harmful. The purpose of this article is to critically review the evidence and the implications for trauma patient management and outcomes. We searched MEDLINE, the Cochrane Database, Index Medicus and article references with a broad search strategy. Relevant results were analysed and critically reviewed in the context of trauma patient management. Our findings present a growing body of evidence documenting the risks and complications of routine spinal immobilization. There is a possibility that immobilization could be contributing to mortality and morbidity in some patients and this warrants further investigation.

ATP-sensitive potassium currents in rat primary afferent neurons: biophysical, pharmacological properties, and alterations by painful nerve injury.

ATP-sensitive potassium (K(ATP)) channels may be linked to mechanisms of pain after nerve injury, but remain under-investigated in primary afferents so far. We therefore characterized these channels in dorsal root ganglion (DRG) neurons, and tested whether they contribute to hyperalgesia after spinal nerve ligation (SNL). We compared K(ATP) channel properties between DRG somata classified by diameter into small or large, and by injury status into neurons from rats that either did or did not become hyperalgesic after SNL, or neurons from control animals. In cell-attached patches, we recorded basal K(ATP) channel opening in all neuronal subpopulations. However, higher open probabilities and longer open times were observed in large compared to small neurons. Following SNL, this channel activity was suppressed only in large neurons from hyperalgesic rats, but not from animals that did not develop hyperalgesia. In contrast, no alterations of channel activity developed in small neurons after axotomy. On the other hand, cell-free recordings showed similar ATP sensitivity, inward rectification and unitary conductance (70-80 pS) between neurons classified by size or injury status. Likewise, pharmacological sensitivity to the K(ATP) channel opener diazoxide, and to the selective blockers glibenclamide and tolbutamide, did not differ between groups. In large neurons, selective inhibition of whole-cell ATP-sensitive potassium channel current (I(K(ATP))) by glibenclamide depolarized resting membrane potential (RMP). The contribution of this current to RMP was also attenuated after painful axotomy. Using specific antibodies, we identified SUR1, SUR2, and Kir6.2 but not Kir6.1 subunits in DRGs. These findings indicate that functional K(ATP) channels are present in normal DRG neurons, wherein they regulate RMP. Alterations of these channels may be involved in the pathogenesis of neuropathic pain following peripheral nerve injury. Their biophysical and pharmacological properties are preserved even after axotomy, suggesting that K(ATP) channels in primary afferents remain available for therapeutic targeting against established neuropathic pain.

Role of neuronal nitric oxide synthase in mediating renal hemodynamic changes during pregnancy.

Renal plasma flow (RPF) and glomerular filtration rate (GFR) are markedly increased during pregnancy. We recently reported that the renal hemodynamic changes observed during pregnancy in rats are associated with enhanced renal protein expression of neuronal nitric oxide synthase (nNOS). The purpose of this study was to determine the role of nNOS in mediating renal hemodynamic changes observed during pregnancy. To achieve this goal, we examined the effects of the nNOS inhibitor 7-nitroindazole (7-NI) on kidney function in normal conscious, chronically instrumented virgin (n = 6) and pregnant rats (n = 9) at day 16 of gestation. Infusion of 7-NI had no effect on RPF (4.7 +/- 0.7 vs. 4.8 +/- 0.9 ml/min), GFR (2.2 +/- 0.2 vs. 2.5 +/- 0.4 ml/min), or mean arterial pressure (MAP; 127 +/- 7 vs. 129 +/- 10 mmHg) in virgin rats. In contrast, 7-NI infused into pregnant rats decreased RPF (8.9 +/- 1.6 vs. 6.5 +/- 1.4 ml/min) and GFR (4.4 +/- 0.7 vs. 3.3 +/- 0.7 ml/min) while having no effect on MAP (123 +/- 4 vs. 123 +/- 3 mmHg). In summary, inhibition of nNOS in pregnant rats at midgestation results in significant decreases in RPF and GFR. nNOS inhibition in virgin rats had no effect on renal hemodynamics. These data suggest that nNOS may play a role in mediating the renal hemodynamic changes that occur during pregnancy.

The injection of intrathecal normal saline reduces the severity of postdural puncture headache.

BACKGROUND AND OBJECTIVES: We investigated whether the injection of 10 mL of normal saline into the subarachnoid space following accidental dural puncture reduced the incidence of postdural puncture headache (PDPH) and the need for epidural blood patch (EBP). METHODS: Twenty-eight patients who experienced accidental dural puncture with an epidural needle had 10 mL of normal saline injected into the subarachnoid space. In 22 patients, the injection was performed immediately through the epidural needle. In 6 patients who had intrathecal catheters placed through the epidural needle, the saline was injected through the catheter before removal. All other patients who experienced wet taps during the same period that the study was in progress but did not receive the saline injection served as a control group, 26 in number. Patients with severe or persistent PDPHs were treated with EBP. RESULTS: Of those patients who received intrathecal normal saline immediately through the epidural needle, 32% developed a headache compared with 62% of controls. Of these, 1 patient who received saline required EBP compared with nine in the control group (P =.004). Of those patients who had intrathecal catheters placed, there were no headaches in the saline group of 6 compared with 3 in the control group of 5, 1 of whom was treated with EBP (P >.05). CONCLUSIONS: The immediate injection of 10 mL intrathecal normal saline after a wet tap significantly reduced the incidence of PDPH and the need for EBP. When an intrathecal catheter had been placed following a wet tap, injection of 10 mL of normal saline before its removal effectively prevented PDPH.

Accuracy in equianalgesic dosing. conversion dilemmas.

The clinical benefit and increased application of opioid rotation has focused attention on efficacy differences between opioids and their respective equianalgesic dose ratios. Understanding the differences between the opioids is critical to understanding their equianalgesic dose ratios and for adjusting therapy following rotation to a new analgesic. The purpose of this article is to describe controversies regarding the relative potencies of these agents as presented in current equianalgesic charts and to provide pharmacologic information to assist the clinician with opioid rotation.

Reduced uterine perfusion pressure during pregnancy in the rat is associated with increases in arterial pressure and changes in renal nitric oxide.

A reduction in nitric oxide (NO) synthesis has been suggested to play a role in pregnancy-induced hypertension. We have recently reported that normal pregnancy in the rat is associated with significant increases in whole-body NO production and renal protein expression of neuronal and inducible NO synthase. The purpose of this study was to determine whether whole-body and renal NO production is reduced in a rat model of pregnancy-induced hypertension produced by chronically reducing uterine perfusion pressure starting at day 14 of gestation. Chronic reductions in uterine perfusion pressure resulted in increases in arterial pressure of 20 to 25 mm Hg, decreases in renal plasma flow (<23%) and glomerular filtration rate (<40%), but no difference in urinary nitrite/nitrate excretion relative to control pregnant rats. In contrast, reductions in uterine perfusion pressure in virgin rats resulted in no significant effects on arterial pressure. Renal endothelial (<4%) and inducible (<11%) NO synthase protein expression did not decrease significantly in the chronically reduced uterine perfusion pressure rats relative to normal pregnant rats; however, significant reductions in neuronal NO synthase were observed (<30%). The results of this study indicate that the reduction in renal hemodynamics and the increase in arterial pressure observed in response to chronic decreases in uterine perfusion pressure in pregnant rats are associated with no change in whole-body NO production and a decrease in renal protein expression of neuronal NO synthase.

Neural blockade for neuropathic pain.

OBJECTIVE: This study reviews the available literature regarding the use of nerve blocks for the management of peripheral neuropathy. DESIGN: A MEDLINE literature review was carried out, examining the existing literature about the use of nerve blocks for the treatment of mononeuropathies and radiculopathy. INTERVENTIONS: The study encompassed the use of local anesthetic peripheral and sympathetic nerve blocks, perineural steroid injections, and neurolytic blocks. RESULTS: Local anesthetic peripheral and sympathetic blocks provide useful diagnostic information but tend to afford only temporary therapeutic benefits in patients with peripheral neuropathy. Perineural steroids provide lasting relief for some patients with radiculopathy and peripheral neuropathy, but in most studies, it is a minority of patients who experience long-term relief. Peripheral neurolytic blocks are helpful for some patients with peripheral mononeuropathy, particularly in the setting of cancer pain. Although there are the risks of exacerbating pain and serious complications, certain patients experience long-term relief. CONCLUSIONS: Most discussions on the management of peripheral neuropathy do not include the use of nerve blocks. Nevertheless, the nerve block procedures discussed here can play an important role in the management of these conditions.