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The available evidence on demineralised bone matrix in trauma and orthopaedic surgery: A systematic review.

ABSTRACT: The aim of this systematic literature review was to assess the clinical level of evidence of commercially available demineralised bone matrix (DBM) products for their use in trauma and orthopaedic related surgery.A total of 17 DBM products were used as search terms in two available databases: Embase and PubMed according to the Preferred Reporting Items for Systematic Reviews and Meta Analyses statement. All articles that reported the clinical use of a DBM-product in trauma and orthopaedic related surgery were included.The literature search resulted in 823 manuscripts of which 64 manuscripts met the final inclusion criteria. The included manuscripts consisted of four randomised controlled trials (level I), eight cohort studies (level III) and 49 case-series (level IV). No clinical studies were found for ten DBM products, and most DBM products were only used in combination with other grafting materials. DBM products were most extensively investigated in spinal surgery, showing limited level I evidence that supports the use Grafton DBM (Osteotech, Eatontown, New Jersey) as a bone graft extender in posterolateral lumbar fusion surgery. DBM products are not thoroughly investigated in trauma surgery, showing mainly level IV evidence that supports the use of Allomatrix (Wright Medical, London, United Kingdom), DBX (DePuy Synthes, Zuchwil, Switzerland), Grafton DBM, or OrthoBlast (Citagenix Laval, Canada) as bone graft extenders.The clinical level of evidence that supports the use of DBM in trauma and orthopaedic surgery is limited and consists mainly of poor quality and retrospective case-series. More prospective, randomised controlled trials are needed to understand the clinical effect and impact of DBM in trauma and orthopaedic surgery.Cite this article: J. van der Stok, K. A. Hartholt, D. A. L. Schoenmakers, J. J. C. Arts. The available evidence on demineralised bone matrix in trauma and orthopaedic surgery: A systemati c review. Bone Joint Res 2017;6:423-432. DOI: 10.1302/2046-3758.67.BJR-2017-0027.R1.

SUBMITTER: van der Stok J

PROVIDER: S-EPMC5539308 | biostudies-other | 2017 Jul

REPOSITORIES: biostudies-other

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Project description:INTRODUCTION:Despite multiple scandals in the medical implant sector, premarket testing has been the attention of little published research. Complications related to new devices, such as the DePuy Articular Surface Replacement (ASR, DePuy Synthes, USA), have raised the issue of how designs are tested and whether engineering standards remain up to date with our understanding of implant biomechanics. Despite much work setting up national joint registries to improve implant monitoring, there have been few academic studies examining the premarket engineering standards new implants must meet. Emerging global economies mean that the markets have changed, and it is unknown to what degree engineering standards vary around the world. Governments, industry and independent regulatory bodies all produce engineering standards; therefore, the comparison of surgical implants across different manufacturers and jurisdictions is difficult. In this review, we will systematically collate and compare engineering standards for trauma and orthopaedic implants around the world. This will help inform patient, hospital and surgeon choice and provide an evidence base for future research in this area. METHODS AND ANALYSIS:This protocol is based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines. We will conduct a systematic review of trauma and orthopaedic engineering standards from four main sources of information as identified in our preliminary scoping searches: governments, industry, independent regulatory bodies and engineering and medical publications. Any current standard relevant to trauma and orthopaedic implants will be included. We will use a predefined search strategy and follow the recommendations of the Cochrane handbook where applicable. We will undertake a narrative synthesis with qualitative evaluation of homogeneity between engineering standards. ETHICS AND DISSEMINATION:No ethics approval is required as no primary data are being collected. The results will be made available by peer-reviewed publication and reported according to PRISMA-P guidelines.

Project description:BackgroundLong-term opioid use, which may have significant individual and societal impacts, has been documented in up to 20% of patients after trauma or orthopaedic surgery. The objectives of this scoping review were to systematically map the research on strategies aiming to prevent chronic opioid use in these populations and to identify knowledge gaps in this area.MethodsThis scoping review is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) Checklist. We searched seven databases and websites of relevant organizations. Selected studies and guidelines were published between January 2008 and September 2021. Preventive strategies were categorized as: system-based, pharmacological, educational, multimodal, and others. We summarized findings using measures of central tendency and frequency along with p-values. We also reported the level of evidence and the strength of recommendations presented in clinical guidelines.ResultsA total of 391 studies met the inclusion criteria after initial screening from which 66 studies and 20 guidelines were selected. Studies mainly focused on orthopaedic surgery (62,1%), trauma (30.3%) and spine surgery (7.6%). Among system-based strategies, hospital-based individualized opioid tapering protocols, and regulation initiatives limiting the prescription of opioids were associated with statistically significant decreases in morphine equivalent doses (MEDs) at 1 to 3 months following trauma and orthopaedic surgery. Among pharmacological strategies, only the use of non-steroidal anti-inflammatory drugs and beta blockers led to a significant reduction in MEDs up to 12 months after orthopaedic surgery. Most studies on educational strategies, multimodal strategies and psychological strategies were associated with significant reductions in MEDs beyond 1 month. The majority of recommendations from clinical practice guidelines were of low level of evidence.ConclusionsThis scoping review advances knowledge on existing strategies to prevent long-term opioid use in trauma and orthopaedic surgery patients. We observed that system-based, educational, multimodal and psychological strategies are the most promising. Future research should focus on determining which strategies should be implemented particularly in trauma patients at high risk for long-term use, testing those that can promote a judicious prescription of opioids while preventing an illicit use, and evaluating their effects on relevant patient-reported and social outcomes.

Project description:BackgroundPatient-Reported Outcome Measures (PROMs) are widely used for measurement of functional outcomes after orthopaedic trauma. However, PROMs rely on patient collaboration and suffer from various types of bias. Wearable Activity Monitors (WAMs) are increasingly used to objectify functional assessment. The objectives of this systematic review were to identify and characterise the WAMs technology and metrics currently used for orthopaedic trauma research.MethodsPubMed and Embase biomedical literature search engines were queried. Eligibility criteria included: Human clinical studies published in the English language between 2010 and 2019 involving fracture management and WAMs. Variables collected from each article included: Technology used, vendor/product, WAM body location, metrics measured, measurement time period, year of publication, study geographic location, phase of treatment studied, fractures studied, number of patients studied, sex and age of the study subjects, and study level of evidence. Six investigators reviewed the resulting papers. Descriptive statistics of variables of interest were used to analyse the data.ResultsOne hundred and thirty-six papers were available for analysis, showing an increasing trend of publications per year. Accelerometry followed by plantar pressure insoles were the most commonly employed technologies. The most common location for WAM placement was insoles, followed by the waist. The most commonly studied fracture type was hip fractures followed by fragility fractures in general, ankle, "lower extremity", and tibial fractures. The rehabilitation phase following surgery was the most commonly studied period. Sleep duration, activity time or step counts were the most commonly reported WAM metrics. A preferred, clinically validated WAM metric was not identified.ConclusionsWAMs have an increasing presence in the orthopaedic trauma literature. The optimal implementation of this technology and its use to understand patients' pre-injury and post-injury functions is currently insufficiently explored and represents an area that will benefit from future study.Systematic review registration numberPROSPERO ID:210344.Supplementary informationThe online version contains supplementary material available at 10.1007/s43465-022-00629-0.

Project description:BackgroundThe primary objective of this systematic review is to examine the characteristics of pilot randomized controlled trials (RCTs) in the orthopaedic surgery literature, including the proportion framed as feasibility trials and those that lead to definitive RCTs. This review aim to answer the question of whether pilot RCTs lead to definitive RCTs, whilst investigating the quality, feasibility and overall publication trends of orthopaedic pilot trials.MethodsPilot RCTs in the orthopaedic literature were identified from three electronic databases (EMBASE, MEDLINE, and Pubmed) searched from database inception to January 2018. Search criteria included the evaluation of at least one orthopaedic surgical intervention, research on humans, and publication in English. Two reviewers independently screened the pool of pilot trials, and conducted a search for corresponding definitive trials. Screened pilot RCTs were assessed for feasibility outcomes related to efficiency, cost, and/or timeliness of a large-scale clinical trial involving a surgical intervention. The quality of the pilot and definitive trials were assessed using the Checklist to Evaluate a Report of a Non-Pharmacological Trial (CLEAR NPT).ResultsThe initial search for pilot RCTs yielded 3857 titles, of which 49 articles were relevant for this review. 73.5% (36/49) of the orthopaedic pilot RCTs were framed as feasibility trials. Of these, 5 corresponding definitive trials (10.2%) were found, of which four were published and one ongoing. Based on author responses, the lack of a definitive RCT following the pilot trial was attributed to a lack of funding, inadequacies in recruitment, and belief that the pilot RCT sufficiently answered the research question.ConclusionsBased on this systematic review, most pilot RCTs were characterized as feasibility trials. However, the majority of published pilot RCTs did not lead to definitive trials. This discrepancy was mainly attributed to poor feasibility (e.g. poor recruitment) and lack of funding for an orthopaedic surgical definitive trial. In recent years this discrepancy may be due to researchers saving on time and cost by rolling their pilot patients into the definitive RCT rather than publish a separate pilot trial.

Project description:Heterotopic Ossification (HO) is a potential long-term complication in orthopaedic surgery. It is commonly classified according to the Brooker classification, which is based on radiological findings. To our knowledge the correlation of histological features to the Brooker grade is unknown as is the association between HO and the indication for revision. The aim of this paper is to analyze the ossification grade of HO tissue in patients undergoing revision hip and knee arthroplasty and to propose a histologically based classification system for HO. We also assess the relationship between the grade of HO and the indication for revision (septic and aseptic revision). From January to May 2019 we collected 50 human HO samples from hip and knee revision arthroplasty cases. These tissue samples were double-blinded and sent for histopathological diagnostic. Based on these results, we developed a classification system for the progression of HO. The grade of ossification was based on three characteristics: Grade of heterotopic ossification (Grade 1-3), presence of necrosis (N0 or N1) and the presence of osteomyelitis (HOES-Score Type 1 to 5). Demographic data as well as surgical details and indication for surgery was prospectively collected from clinical records. Fifty tissue samples were harvested from 44 hips and 6 knee joints. Of these 33 exhibited Grade I ossifications (66%), followed by 11 Grade II (22%) and one Grade III (2%). Necrosis was noted in two tissue samples (4%) and 2 more had osteomyelitis findings according to HOES-Score. Six samples (12%) with radiologically suggestive of HO turned out to be wear-induced synovitis, SLIM Type 1. Of these cases 16 were septic (32%) and 34 aseptic (68%) revisions. Most of the HO tissue samples were classified as a low-grade. High-grade ossification-Score is rare. Higher grades of ossification seem to be associated with septic revision cases. Wear-induced synovitis potentially influences HO development. A histological scoring system for ossification grading can be derived from the data presented in this study.

Project description:BackgroundAlthough damage control (DC) surgery is widely assumed to reduce mortality in critically injured patients, survivors often suffer substantial morbidity, suggesting that it should only be used when indicated. The purpose of this systematic review was to determine which indications for DC have evidence that they are reliable and/or valid (and therefore in which clinical situations evidence supports use of DC or that DC improves outcomes).MethodsWe searched 11 databases (1950-April 1, 2019) for studies that enrolled exclusively civilian trauma patients and reported data on the reliability (consistency of surgical decisions in a given clinical scenario) or content (surgeons would perform DC in that clinical scenario or the indication predicted use of DC in practice), construct (were associated with poor outcomes), or criterion (were associated with improved outcomes when DC was conducted instead of definitive surgery) validity for suggested indications for DC surgery or DC interventions.ResultsAmong 34,979 citations identified, we included 36 cohort studies and three cross-sectional surveys in the systematic review. Of the 59 unique indications for DC identified, 10 had evidence of content validity [e.g., a major abdominal vascular injury or a packed red blood cell (PRBC) volume exceeding the critical administration threshold], nine had evidence of construct validity (e.g., unstable patients with combined abdominal vascular and pancreas gunshot injuries or an iliac vessel injury and intraoperative acidosis), and six had evidence of criterion validity (e.g., penetrating trauma patients requiring > 10 U PRBCs with an abdominal vascular and multiple abdominal visceral injuries or intraoperative hypothermia, acidosis, or coagulopathy). No studies evaluated the reliability of indications.ConclusionsFew indications for DC surgery or DC interventions have evidence supporting that they are reliable and/or valid. DC should be used with respect for the uncertainty regarding its effectiveness, and only in circumstances where definitive surgery cannot be entertained.

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The available evidence on demineralised bone matrix in trauma and orthopaedic surgery: A systematic review.

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