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The author's right to be identified as the author of this work has been asserted under the UK Copyright, Designs and Patents Act 1988. The publisher and the author make no representations or warranties as to the accuracy or completeness of the content. of this work and expressly disclaims all warranties, including without limitation all implied warranties of fitness for a particular purpose.

Orthopedic Oncology

Evidence-Based Medicine Series

What are the most important principles of evidence- based orthopedics?

Less emphasis is placed on the clinician's own professional authority.1 His or her experiences, beliefs and observations alone are not enough to make satisfactory decisions regarding patient care. The ultimate goal of a clinician is to provide the best clinical care for his or her patient.4 To that end, the clinician's own experiences and training are important assets.

Evidence-based orthopedics promotes the need to evaluate the evidence available in the medical literature from published research and incorporate it into clinical practice. However, there is a wealth of information available in the literature that can assist the physician in many ways, from evaluating the effectiveness of a particular treatment to recommending lifestyle changes that can help prevent disease.5 As such, it is important for the physician to evaluate and incorporate this evidence. into his reasoning and judgment when considering the best approach to patient care.

To fully appreciate the principles of evidence-based orthopedics, it is helpful to have an understanding of the importance and value of this approach. Failure to consider such evidence when adopting a clinical approach may result in patients being denied the best possible care.4 There is a greater risk of applying an inappropriate treatment or not applying a treatment. suitable.

What are some common misconceptions about evidence- based orthopedics?

Integrating questionable evidence into a clinical approach may cause more harm than good to the patient.3 Therefore, evidence-based orthopedics is specific in its emphasis on published evidence in the literature and careful evaluation of that evidence.7 Therefore, clinicians must be able to understand study design and critically appraise the literature.5 Different study designs are usually represented in a hierarchy of evidence (Figure 1.1), where they are ranked according to the validity of their results. Randomization is an important feature of a study because of the random allocation of patients to treatment and control groups, which balances known and unknown prognostic factors between the two groups.9 However, the clinician must still determine whether the study is methodologically sound.

Integrating evidence and clinical expertise

What are the most important principles of evidence-based orthopedics?

Expert opinion is at the bottom, being the most susceptible to bias and producing the most questionable evidence.8 At the top of the hierarchy are randomized controlled trials and meta-analyses, which are the least vulnerable to bias.

Patient values

The need for evidence

The evidence is unequal

What are some common misconceptions about evidence-based

Evidence-based orthopedics replaces the judgment of the clinician

Only randomized controlled trials are acceptable evidence

How do you apply these principles to a clinical approach?

The evidence cycle

What is an example of applying these principles to a clinical approach?

Case scenario

The clinician is bound to a certain course of action by the evidence

What are systematic reviews and meta-analyses?

Meta-analyses are an extension of systematic reviews in that they pool data across all studies to effectively increase sample size and produce a single estimate of treatment effect.10. As for RCTs, there are quality issues that, if not met, can move systematic reviews and meta-analyses lower in the hierarchy.

What are observational studies?

  • What are randomized controlled trials?
  • What are systematic reviews and meta-analyses?
  • What are observational studies?
  • What are case series and case reports?
  • What are systems of hierarchies?
  • What are grades of recommendation?

First of all, systematic reviews and meta-analyses that include exclusively RCTs are of higher quality and provide more convincing evidence than those that include non-randomized studies.11,12 Second, even among those meta-analyses including only RCTs. the power of the single treatment effect estimate depends on the homogeneity of the RCTs. If the included trials have accurate and consistent results, the results of meta-analyses are strong, whereas heterogeneous trials with inconsistent results and large confidence intervals make statistical pooling less reliable.6.

What are randomized controlled trials?

Second, the authors acknowledge that both RCTs and observational studies can move up or down levels on this hierarchy, depending in part on the methodological quality of the trial. These levels of evidence are easily accessible at the Oxford Center for Evidence-Based Medicine website, www.cebm.net.12 In a review of the orthopedic literature in 2003, it was demonstrated that only 11.3% of the studies (therapy, prognostic, diagnostic, and economic) qualify as level I according to the Oxford levels of evidence.7.

What are case series and case reports?

CHAPTER 2 Understanding Hierarchies of Evidence and Degrees of Recommendation The results are definitive because no generalizations are made based on any individual patient population. This includes both benefits and harm outcomes associated with the cohort studies below in the hierarchy of evidence.

What are systems of hierarchies?

  • What are the criteria for determining level of evidence?
  • What are the steps involved in critical appraisal?
  • What are some other examples of tools for critical appraisal?

Reproduced from Grading quality of evidence and strength of recommendations, Atkins D, Best D, Briss PA, et al with permission from BMJ Publishing Group Ltd.). Thus, the hierarchies of evidence and degrees of recommendation together provide clinicians with a method for finding the "best available" evidence, and in turn, facilitate evidence-based decision making.

Figure 2.1 Assigning grades of evidence by GRADE Working Group. (Reproduced from Grading quality of evidence and strength of recommendations,  Atkins D, Best D, Briss PA, et al, 328, 1490, 2004 with permission from BMJ Publishing Group Ltd.)
Figure 2.1 Assigning grades of evidence by GRADE Working Group. (Reproduced from Grading quality of evidence and strength of recommendations, Atkins D, Best D, Briss PA, et al, 328, 1490, 2004 with permission from BMJ Publishing Group Ltd.)

What are the criteria for determining level of evidence?

Critical appraisal involves a judgment about how much confidence can be placed in the evidence and recommendations provided by a study.1 However, what is the "best available" evidence. The most important idea to keep in mind is that evidence-based orthopedic surgery makes effective use of all types of available evidence in clinical decision-making, whether it is an RCT or a case review.2 The tools for critical appraisal discussed herein. chapter will help.

What are the steps involved in critical appraisal?

The treatment effect can also be presented as a relative risk, or the risk of an adverse event in patients in the treatment group compared to those in the control group. Adequacy of follow-up duration and whether the results can be applied to manage patients in their practice should also be considered. 11.

What are some other examples of tools for critical appraisal?

To assess the results of forecasting studies, one must ask how likely the outcomes are over time, and how accurate the probability estimates are. When applying the results to patient care, it must be determined whether the participants in the study are comparable to the participants in their practice.

Table 4.1  Levels of evidence for diagnostic studies
Table 4.1 Levels of evidence for diagnostic studies

Will reproducibility and interpretation of the test result be satisfactory in my setting?

Orthopedic surgeons rely heavily on radiographs for diagnosis, so it is important that some mention of the imaging protocol, or lack thereof, be documented in well-reported studies. So much of orthopedic diagnosis is radiographic, and the mode/orientation of the imaging beam changes the radiographic image so much that the acquisition protocol should be standardized and well described to the reader.

If the images are not acquired in a precise manner, the reproducibility and reproducibility of the study will be compromised, as will the results of the study.

Will the results change my management of the patient?

Will patients be better off as a result of the test?

Did clinicians face diagnostic uncertainty?

Was there an independent, blind comparison with a reference standard?

Did test results influence the decision to perform the reference standard?

Were methods for performing the test described in detail to permit replication?

Are test likelihood ratios, or data necessary for their calculation, provided?

Although less clinically useful than LRs, these terms can still be used in their calculation.2,7 Applicability: How can I apply the results to my patient care. In addition, all patients should be analyzed in the groups to which they were randomized, and the study should not be stopped prematurely but continued until the planned follow-up2,8.

How large was the treatment effect?

How precise was the estimate of the treatment effect?

Can the results be applied to my patient?

Did the intervention and control groups start with the same prognosis?

Was prognostic balance maintained as the study progressed?

Were groups prognostically balanced at the study’s completion?

The main disadvantage of retrospective studies is that data quality is mainly based on patient records, and these records may not be sufficiently accurate. Prognostic factors should not be confused with risk factors (ie, the patient characteristics associated with disease in the first place).

Was the patient sample representative?

In case-control studies, one starts with the outcome of interest and then looks backward to examine potential causal factors by comparing those who have the outcome (i.e., cases) to those who do not have the outcome (i.e., controls). Another disadvantage of retrospective studies is that they are prone to recall bias, and this reduces the validity of the results.2,9.

Were all clinically important outcomes considered?

In prognostic studies, researchers examine prognostic variables to determine their relationship to potential outcomes, disease, therapeutic treatment, and predict the probability associated with their effect (ie, the probability that these outcomes can be expected to occur). 2,9 Prediction can be improved by looking at subgroups defined by demographic variables (eg, gender, age, comorbidity factors, socioeconomic status, stage of disease). In the best-designed studies, investigators will distinguish subgroups of patients based on prognostic variables.9 When variables or factors predict which patients do better or worse, they are called prognostic factors.

Are the likely treatment benefits worth the potential harm and costs?

This is due to loss to follow-up and because patients are rarely included in the study at the same time. This means that survival curves are more accurate at earlier follow-up periods.

Were study patients and their management similar to those in my practice?

Was follow-up sufficiently long?

Can I use the results in the management of patients in my practice?

Were outcome criteria objective and unbiased?

How likely are the outcomes over time?

How precise are the estimates of likelihood?

  • What is a narrative review?
  • What is a systematic review?
  • What are the differences between a systematic review and a narrative review?
  • What is a meta-analysis?
  • Where do narrative reviews, systematic reviews, and meta-analyses rank on the hierarchy of evidence?
  • How are systematic reviews and meta-analyses critically appraised?

There are three types of reviews: narrative reviews, systematic reviews and meta-analyses.1,2 Each of these is discussed in detail in this chapter. Where do narrative reviews, systematic reviews and meta-analyses rank in the hierarchy of evidence.

What is a narrative review?

A clear history of relevant personal and work exposures and the nature of symptoms can lead to a high probability of an accurate diagnosis. The Phalen wrist flexion and wrist compression tests have the highest overall accuracy, while the Tinel nerve impingement test is more specific for the axonal damage that can occur as a result of moderate to severe CTS .

What is a systematic review?

Electrodiagnosis may include a variety of tests and is commonly used to assess the presence/severity of neuropathic changes and to rule out alternative diagnoses that overlap in presentation with CTS. The aim of our research was to evaluate the effectiveness of orthopedic devices for the treatment of tennis elbow.

What is a meta-analysis?

All randomized clinical trials (RCTs) describing individuals with diagnosed lateral epicondylitis and comparing the use of an orthotic device as a treatment strategy were assessed for inclusion. Two reviewers independently assessed the validity of the included trials and extracted data for relevant outcome measures.

Where do narrative reviews, systematic reviews, and meta-analyses rank

What are the differences between a systematic review, meta-analysis and a

Differences between a narrative review and systematic review also exist in the quality of the literature search. In a systematic review, studies are included based on many different factors such as validity of the results, research methodology, type of treatments and the outcome measures used.12 Various tools such as the Jadad score, T.C.

What is a critical appraisal of systematic reviews and meta-analyses?

  • What are the different types of economic analyses?
  • Which costs are included in an economic analysis?
  • What perspective is adopted in an economic analysis and how does this affect the costs included?
  • What is the time horizon adopted in an economic analysis?
  • What are sensitivity analyses?
  • How are economic evaluations interpreted?

Systematic reviews are becoming increasingly important in contemporary clinical research due to the vast amount of literature published every year. Systematic reviews for evidence-based management: how to find them and what to do with them.

What are the different types of economic analyses?

Between 1970 and 2008, the percentage of United States gross domestic product (GDP) spent on health care increased from 7.1% to 16%.1 Economic estimates are important because people, time, equipment, facilities, and knowledge are scarce resources. and choices must be made to determine optimal use. 2,3 Economic analyzes identify, measure, evaluate, and compare alternative courses of action in terms of costs and consequences. 2,3 They provide standardized and quantitative estimates of potential unit cost. of the health benefit achieved by a given procedure, which helps achieve the primary goal of identifying the procedures that produce the greatest health benefit for a given cost.1 The breadth of outcomes considered varies according to the type of economic analysis performed. . Furthermore, the costs and benefits considered differ depending on the perspective adopted in the analysis.

Cost-minimization analysis

C H A P T E R 6 Economic analysis An example of an appropriate cost-effectiveness study would be an evaluation of the cost of successful fusion in the treatment of open tibial fractures. Thus, although intramedullary nailing is more expensive, it is more cost-effective for the treatment of open tibial fractures because of the lower cost per successful union.4.

Cost-utility analysis

Recent studies report that intramedullary nailing yielded a much lower nonunion rate (15%) than external fixation (42%).

Cost-effectiveness analysis

Which costs are included in an economic analysis?

The costs included in an economic analysis will vary based on the time frame and perspective considered in the study. Direct medical costs include all costs directly related to the procedure, including those for personnel, supplies, and the facility involved in the treatment.

Which perspective is adopted in an economic analysis and how does this affect the

Direct nonmedical costs include costs borne by patients and their families during treatment (ie, transportation).4 Indirect costs include costs associated with lost productivity, usually valued as lost wages or a monetary value of time. It is also important to consider the downstream costs of resources that will be consumed in the future but are still attributable to the procedure.4 An adjustment is also required for the different timing of costs and consequences due to time preference.

Cost-benefit analysis

How are economic evaluations interpreted?

In this case, the hospital administration, the surgeon and the patient must decide whether the increased efficiency is worth the additional cost.2 When the result falls into a non-dominance cell (cells 7-9), it may be useful to calculate the ICER or ICUR of the new procedure.4 In addition, there are guidelines to recommend whether a new procedure should be adopted or rejected. In contrast, the primary payer perspective includes all medical costs covered by the primary payer beyond those incurred in the hospital.

What is the time horizon adopted in an economic analysis?

In cell 2, the new procedure is more expensive and less effective than the standard treatment and should not be adopted. Sensitivity analyzes involving 20% ​​changes compared to the base case analysis showed this result to be robust.9 Perspectives that can be adopted include that of the government.

What are sensitivity analyses?

  • Are hip fracture patients receiving appropriate evalua- tion and treatment for osteoporosis?
  • How do I decide which fragility fracture patients are at high risk for future fracture and which patients to treat

Hip fractures are anatomically classified as intracapsular or extracapsular depending on the location of the fracture relative to the insertion of the hip joint capsule on the proximal femur. Osteoporosis is characterized by a reduction in bone mass and disruption of skeletal microarchitecture, leading to increased susceptibility to minimal trauma fractures.4 More than 200 million people worldwide suffer from osteoporosis5 and osteoporotic fractures account for 0.83% of the global burden of non-communicable diseases. disease.6 During the year.

Quality of the evidence Level I

What medications reduce the risk of hip fracture?

Does starting bisphosphonate therapy interfere with fracture healing?

What are the side effects associated with long-term bisphosphonate therapy?

Are hip fracture patients receiving appropriate evaluation and treatment for

Case clarification

Relevance

Current opinion

Finding the evidence

A follow up call 6 weeks later to remind them of the questions and after 6 months to find out if the OP was addressed. INT1: Patients sent a personalized letter describing their risk factors for OP and recommending follow-up with their primary care physician.

Table 7.1  Summary of randomized controlled trials to improve the diagnosis and treatment of osteoporosis in patients with hip fracture Reference Population Fracture site
Table 7.1 Summary of randomized controlled trials to improve the diagnosis and treatment of osteoporosis in patients with hip fracture Reference Population Fracture site

Recommendations

How do I decide which fragility fracture patients are at high risk for future

Clinical risk factors—presence of a previous fragility fracture after age 40 or recent prolonged use of glucocorticoids—increase fracture risk independent of BMD. The FRAX tool can be used to calculate the 10-year probability of a major osteoporotic fracture (clinical back, hip, forearm, or proximal humerus) and hip fracture [overall quality: high].

What medications reduce the risk of hip fracture?

3 Determine the patient's absolute fracture risk category using the lowest T-score of the recommended skeletal sites (lumbar spine, total hip, femoral neck, and trochanter, with a radius of 1/3 of the forearm if the spine or hip is not being valid). 4 Evaluate clinical factors that may move the patient to a higher fracture risk category (fragility fractures after age 40 years and current systemic glucocorticoid therapy for >3 months elevate the patient to the next higher risk category; if both factors are present, move to a high risk category .risk).

Table 7.3  North American and European guidelines for fracture risk assessment and treatment of osteoporosis
Table 7.3 North American and European guidelines for fracture risk assessment and treatment of osteoporosis

Recommendation

Does starting bisphosphonate therapy interfere with fracture healing?

FIT-2; n = 4432; postmenopausal women with low femoral neck BMD but no vertebral fracture; alendronate 5 mg/d (then increased to 10 mg/d after 24 months) or placebo; 4 years. -MN; n = 1226; postmenopausal women with ≥2 vertebral fractures; risedronate 2.5 mg/d (discontinued halfway through the trial) or risedronate 5 mg/d or placebo; 3 years.

Table 7.4  Efficacy of pharmacologic agents on the relative risk reduction of hip fractures in postmenopausal women
Table 7.4 Efficacy of pharmacologic agents on the relative risk reduction of hip fractures in postmenopausal women

What are the side effects associated with long-term bisphosphonate

Woo et al.110 also conducted a systematic review of all possible ONJ cases reported between 1966 and 2006 and reached a similar conclusion as the ASBMR task force on ONJ.

Table 7.6  ASBMR Task Force on ONJ recommendations and precautions for patients with osteoporosis or other nonmalignant bone disease  initiating or already receiving bisphosphonate therapy 108
Table 7.6 ASBMR Task Force on ONJ recommendations and precautions for patients with osteoporosis or other nonmalignant bone disease initiating or already receiving bisphosphonate therapy 108

Quality of the evidence Level II

  • What is the diagnostic modality of choice to detect DVT?
  • Which patients require thromboprophylaxis?
  • Which orthopedic procedures require thromboprophy- laxis?
  • Are mechanical thromboprophylactic measures effective?
  • What is the role of inferior vena caval filters?
  • What is the ideal anticoagulant agent?
  • What about aspirin or warfarin?
  • When should anticoagulant treatment be initiated?
  • What should the duration of anticoagulant treatment be?
  • What is the risk of bleeding with anticoagulants?
  • What is the diagnostic modality of choice to detect DVT?
  • Which patients require thromboprophylaxis?
  • What is the role of IVC filters?
  • Are mechanical
  • What is the ideal anticoagulant agent?

Foot pumps Two studies (N = 147 patients) reported the use of foot arteriovenous pulse systems in patients undergoing hip fracture surgery.75,76 These devices significantly reduced the incidence of DVT and PE compared with controls (relative risk = 0.20, p Judicious use is recommended, especially in patients with contraindications to anticoagulant therapy [overall quality: moderate].

Table 8.2  Risk factors for venous thromboembolism Surgery
Table 8.2 Risk factors for venous thromboembolism Surgery

Findings

When should anticoagulant treatment be initiated?

What about aspirin or warfarin?

What should the duration of anticoagulant treatment be?

What is the risk of bleeding with anticoagulants?

  • How common are anemia and blood transfusion in orthopedic surgery, and what strategies reduce transfusion
  • What is an appropriate hemoglobin level to act as a transfusion trigger?
  • What is the effect of anemia on morbidity and mortality?
  • What is the effect of anemia and blood transfusion on function?
  • What are the risks of blood transfusion?

How common are anemia and blood transfusion in orthopedic surgery, and

What is the effect of anemia on morbidity and mortality?

What is an appropriate hemoglobin level to act as a transfusion trigger?

What are the risks of blood transfusion?

What is the effect of anemia and blood transfusion on function?

  • What is the role of wound culture in diagnosing and treating orthopedic infections?
  • What is the management of infected hardware?

What are the current

  • What are the current recommendations regarding pro- phylactic antibiotic administration in the prevention of
  • What are the current recommendations regarding screen- ing for meticillin-resistant Staphylococcus aureus (MRSA),
  • What is the optimal diagnostic approach in a patient with a suspected wound infection?

What are the current

Quality of the evidence (best available)

What is the optimal diagnostic approach in a patient with a suspected wound

The diagnosis of a wound infection, especially the extent of the infection, is important in guiding treatment. Currently, many institutions screen for MRSA using a polymerase chain reaction (PCR) test for gene sequencing and identification of nasal carriage of MRSA.

What is the role of wound culture in diagnosing orthopedic infections?

CRP and ESR should be used together to support or help rule out a suspected wound infection. For deep infections, prompt irrigation and debridement is recommended, but hardware removal should be delayed until fracture stability is achieved.

What is the management of infected internal fixation hardware?

The impact of surgical site infections in the 1990s: Attributable mortality, excessive length of hospitalization and extra costs. Single versus multiple dose antibiotic prophylaxis in the surgical treatment of closed fractures: a meta-analysis.

Quality of the evidence Level III

  • How accurate is clinical examination for the diagnosis of acute gout and what role does joint aspiration for docu-
  • What is the role of oral colchicine in treatment of acute gout?
  • How effective are other treatments including nonsteroi- dal anti-inflammatory drugs (NSAIDs), corticosteroids,
  • What is the role for use of chronic anti-inflammatory therapy (colchicine, NSAIDs, etc.) in patients with gout?
  • How accurate is clinical
    • High dose Colchicine versus placebo Ahern 1987
    • High dose Colchicine versus placebo Ahern 1987
  • What is the role of colchicine in prophylaxis during initial urate-lowering
    • Is preoperative echocardiography indicated for asymp- tomatic patients?
    • Which approaches to delirium prevention work?
    • Does comanagement improve processes and outcomes?
    • Are beta-blockers useful in perioperative management?
    • What is the harm associated with delay to surgery?
  • Is preoperative echocardiography indicated for asymptomatic patients?

Two studies (n = 229 patients) provide data on the use of colchicine for the treatment of acute gout. Colchicine prophylaxis is effective in preventing acute gout flares during initial urate-lowering therapy [overall quality: moderate].

Figure 11.1 Efficacy of colchicine vs. placebo in 50% pain reduction.
Figure 11.1 Efficacy of colchicine vs. placebo in 50% pain reduction.

Quality of the evidence

  • Which approaches to delirium prevention work?
  • Does comanagement improve processes and outcomes?
  • Are beta-blockers useful in perioperative management?
  • What is the harm associated with delay to surgery?
    • William Axelrad 1 and Thomas A. Einhorn 2
  • What factors negatively affect bone healing?
  • clarification

For patients on chronic beta-blocker therapy undergoing nonvascular surgery, continue beta-blockers in the perioperative period. Do not initiate high-dose beta-blockers in naïve patients in the immediate perioperative period.

Finding the evidence: aging and bone healing

Cells isolated from patients over 40 years old showed an increase in the expression of the apoptosis markers p53 and, to a lesser extent, p21, with a significant increase in the rate of apoptosis. Interestingly, at both the 3-week and 6-week time points, no difference in the amount of new bone was detected between diabetic and nondiabetic animals.

Finding the evidence: endocrine/nutritional deficits

At both the 2-week and 4-week time points, the radiographic area of ​​callus was significantly greater in the OP-1-treated animals. The results in the single animal study reviewed showed a positive effect of OP-1 on fracture callus mineralization, although it had no effect on fracture callus strength.

Finding the evidence: diabetes

This increased callus did not result in a change in moment to failure between any of the groups tested, including a non-diabetic control group. This study in isolation does not indicate a dramatic potential for OP-1 use in acute fractures.

Finding the evidence: obesity

The increasing number of HIV infections and the increasing number of AIDS cases worldwide, especially among the aging population, has implications for both the incidence and treatment of fractures.60-63 HIV infection has been shown to be associated with an increased risk of osteopenia. and osteoporosis, as well as an increase in serum levels of the inflammatory cytokine TNF-α.64 Delayed wound healing and infection after fracture treatment may increase in patients with HIV,65,66 specifically in association with open fractures.67,68 Only one study has found an increased risk of fracture nonunion was demonstrated in individuals affected by HIV, but the difference in fracture rates only approached significance (p = 0.059) in this small cohort of patients with open fractures.68 Recommendation. With regard to HIV-infected patients, the available evidence suggests a trend that Gustilo-Anderson type II and III fractures are at increased risk for infection and possibly nonunion, although larger randomized controlled trials are needed to better answer this question. [general quality: moderate].

Finding the evidence: HIV/AIDS

Studies on the effects of alcohol abuse on the rate of fracture healing in the clinical setting are scarce. In the subgroup of patients who had a transverse tibial fracture, a statistical difference in the time to achieve union was present.

Finding the evidence: fracture of the appendicular skeleton

When should orthobiologics be used in the acute setting?

In this study, 25 patients were randomized to either instrumented posterior fusion supplemented with either autograft or BMP-2 or BMP-2 alone without instrumentation.120 The rate of fusion at 1 year follow-up was only 40% in the patients treated with autograft, whereas 100% of the patients treated with BMP-2 achieved fusion. They found no difference in rates of adherence or satisfaction among the 24 patients (80%) available at final follow-up.

Finding the evidence: primary spinal fusion

What orthobiologics are recommended for healing of recalcitrant

Our patient returns for a 2-year follow-up with constant pain in the lumbar spine.

Finding the evidence: nonunion of long bones

What rules govern the use of orthobiologics?

Regulatory process

Finding the evidence: spinal pseudoarthrosis

What are the reported risk factors with the use of the various FDA/EMEA

  • Does navigation improve component alignment follow- ing hip arthroplasty?
  • Which type of navigation should be used and how should the patient be positioned?
  • When should navigation be used?
  • Does navigation improve alignment in hip resurfacing?
  • Does navigation improve clinical outcomes following THR?

Does navigation improve component alignment following hip

There is a consistent reduction in outliers (as defined by Leewineek et al.6) using either CT or imageless navigation. The study by Leenders et al.4 included three cohorts of patients, the first of which was performed freehand, while the subsequent two were randomized to either freehand.

Table 14.1  Best evidence comparing hip navigation with free hand
Table 14.1 Best evidence comparing hip navigation with free hand

Which type of navigation should be used and how should the patient be

In response, a number of techniques have evolved to allow acquisition of the frontal plane of the pelvis while operating on the patient in the lateral position. Two of the studies clearly specify that the patient is laterally positioned and used the posterior approach.

Summary

When should navigation be used?

There are other reports on the use of navigation in dysplasia by Jingushi38 (imageless) and Ohashi39 (CT-based). Studies that have compared the use of navigation and freehand placement of the femoral guide pin are summarized in Table 14.5.

Table 14.4  Operative time
Table 14.4 Operative time

Does navigation improve alignment in hip resurfacing?

Since femoral head reconstruction is technically demanding, and is a newer technique, it lends itself to computer navigation. Based on the weaker evidence above, there appears to be an improvement in alignment in the coronal plane with the use of imageless navigation, which is associated with an increase in time for the procedure of between 0 and 15 minutes.

Does navigation improve clinical outcomes following THR?

This study also reported on the reproduction of the planned leg length at the end of the procedure; as this was significantly improved in the navigated group, it may explain the improvement in results above. It is not surprising that simply improving the alignment of the cup does not show a clear improvement in clinical results.

Recommendation None

Is HCLPE more resistant to wear than ultra-high molec- ular weight polyethylene (UHMWPE)?

Does the improved wear rate of HCLPE allow for the use of larger femoral head sizes in THA?

Has the advent of HCLPE resulted in a decrease in the prevalence of osteolysis after THA?

Can the use of HCLPE compromise mechanical properties??

Is HCLPE more resistant to wear than UHMWPE?

All manufacturers report significant decreases in wear rates and report 85-100% reductions in wear from hip simulator data.3 HCLPE was highly resistant to wear and outperformed conventional polyethylene (i.e., non-crosslinked UHMWPE) in environments felt to increase the wear, such as the presence of third body wear particles and rough femoral heads.4–6. In order to interpret the considerable amount of data reported on HCLPE, a basic knowledge of the various methods for measuring in vivo wear of polyethylene is necessary.

Does the improved wear rate of HCLPE allow for the use of larger femoral head

The use of UHMWPE in patients with active THA will cause osteolysis and aseptic loosening. PubMed (www.ncbi.nlm.nih.gov/pubmed/) - search by sensitivity using the keywords "crosslinked" OR "cross-linked".

Can the use of HCLPE compromise mechanical properties?

In-vitro studies have demonstrated increased inflammatory response to HCLPE wear particles, but clinical studies using CT scans to assess osteolysis show significant reductions in lytic lesions.30-33 Others have shown that HCLPE generates a similar response. macrophages to traditional polyethylene con- and have made the logical conclusion that their lower rate of consumption should reduce osteolysis.34 Recommendation.

Has the advent of HCLPE resulted in a decrease in the prevalence of osteolysis

Characterization of a highly cross-linked ultra-high molecular weight polyethylene in clinical use in total hip arthroplasty. In vivo comparative wear study of traditional and highly cross-linked polyethylene in total hip arthroplasty.

What are the differences relating to the surgical technique and hospitalization

  • What are the differences relating to surgical technique and hospitalization after HR and THA?
  • Is acetabular bone jeopardized in hip resurfacing?
  • How precise is biomechanical reconstruction of the hip joint after HR and THA?
  • Does HR provide better clinical outcomes and activity level than THA?
  • Does HR offer greater range of hip motion than THA?
  • Do patients have better gait and postural balance after HR?
  • Is there any difference between procedures in the rate of complication?
  • What level of metal ion release is seen after HR and metal-on-metal THA?
  • Which procedure has higher failure rate: HR or THA?
  • Is HR revision surgery easier than revision of THA, and does it provide better outcomes?

PubMed (www.ncbi.nlm.nih.gov/pubmed) sensitivity search using keywords: “hip resurfacing OR surface replacement arthroplasty” AND “acetabular bone”. In HR, the size of the acetabular component (and thus the amount of acetabular bone resection) is determined by the diameter of the femoral component.

How precise is biomechanical reconstruction of the hip joint after HR

Current opinion suggests that leg length equality and femoral offset restoration is more precise with HR. HR has the potential to preserve femoral offset and leg length better than THA [overall quality: moderate].

Does HR provide better clinical outcomes and activity level than THA?

HR has less potential than THA for restoring normal biomechanics in subjects with significant preoperative malformed anatomy [overall quality: low].

Does HR offer greater range of hip motion than THA?

No difference in postoperative ROM between HR and THA [overall quality: low]. No difference in gait pattern and postural balance after HR and LDH-THA [overall quality: low].

Table 16.1  Summary of clinical outcomes Study Level of
Table 16.1 Summary of clinical outcomes Study Level of

Is there any difference between procedures in the rate of complication?

They found that patients who received HR and LDH-THA returned to more normal gait patterns than patients who had small-diameter femoral heads. Gait speed is greater and postural balance appears better after HR than after THA [general quality: low].

Do patients have better gait and postural balance after HR?

There was no difference in the incidence of HO in two other retrospective studies of HR and THA.24,40. There appears to be no difference between HR and THA in rates of infection, nerve damage, and thromboembolic events [overall quality: moderate].

What level of metal ion release is seen after HR and metal-on-metal THA?

Heterotopic ossification One randomized study and three retrospective studies have discussed heterotopic ossification (HO) after HR. The cobalt and chromium ion release after HR and 28 mm THA showed conflicting results depending on the type of implants studied [overall quality: good].

Table 16.2  Comparison of complications after HR and THA
Table 16.2 Comparison of complications after HR and THA

Which procedure has higher failure rate: HR or THA?

There was no significant difference in the risk of revision for THA in relation to gender, while for HR women had a significantly higher rate of revision. Durom LDH-THA showed significantly higher release of cobalt ions compared to Durom HR.

Is HR revision surgery easier than revision of THA, and does it provide better

  • What are the orthopedic generations of ceramic?
  • What bearing options are available when using ceramics in total hip arthroplasty?
  • Are the clinical outcomes of ceramic total hip replace- ments equal to those of more conventional articulations?
  • Does a ceramic articulation truly reduce the amount of wear and wear-related osteolysis?
  • What is the risk of fracture?
  • What is the risk of squeaking for a patient considering a ceramic total hip replacement?
  • What is the risk of revision and what revision options are available if ceramic fails?

Biomechanical reconstruction of the hip: a randomized trial comparing total hip resurfacing and total hip arthroplasty.

What are the orthopedic generations of ceramic?

Second-generation ceramics were developed with the addition of calcium oxide or magnesium oxide materials that would limit the increase in alumina grain size during the long sintering process,12 resulting in a higher-strength product. Equalizing leg lengths and maximizing stability are two crucial goals of total hip arthroplasty.13 The availability of numerous liners and head options is one way to achieve this goal.

Are the clinical outcomes of ceramic total hip replacements equal to those

The aforementioned complications of squeaking and fracture associated with ceramic articulations are related to design and technique, and apply to a relatively low percentage of patients in clinical practice.13 Loss of all these options may currently be the most significant disadvantage of CC THA. There is less modularity with ceramic bearings compared to metal and polyethylene implants, limiting the options available to optimize leg lengths and stability.

What bearing options are available when using ceramics in total hip arthroplasty?

Patients obtain a significant improvement in disease-specific outcome and quality-of-life outcomes after a CC total hip replacement [overall quality: high]. Patients can expect improvement in disease-specific and quality-of-life outcomes at least equivalent to a conventional hard and soft total hip replacement at medium-term follow-up [overall quality: high].

Does a ceramic articulation truly reduce the amount of wear and wear-related

An additional medium- to long-term RCT (median 8 years) comparing 30 alumina CC with 26 ceramic-on-polyethylene articulations reported significantly greater wear in the polyethylene group.18 One hip showed radiolucency around the acetabular component, but without accelerated wear and no osteolysis reported in any of the patients.18. In a longer-term RCT comparing 30 CC with 26 ceramic-on-polyethylene reports, an attempt was made to measure the amount of wear in a ceramic articulation.18 There was significantly greater wear in the polyethylene group, with an average annual wear of 0 .11 mm/.

What is the risk of fracture?

Improvements in manufacturing and components have reduced the risk of ceramic component breakage [overall quality: moderate]. Fracture risk may be increased in young, heavier, active men [overall quality: very low].

What is the risk of squeaking for a young active patient considering a ceramic

Care must be taken when inserting ceramic liners to avoid the risk of insertion chips. The risk of a creaky articulation is increased in the younger, heavier and taller patient [general quality: very low].

Is a CC articulation less likely to require revision than a conventional

A prospective randomized trial comparing alumina ceramics on ceramic with ceramics on conventional polyethylene bearings in total hip arthroplasty. Ceramic-on-ceramic bearings versus ceramic-on-polyethylene bearings in total hip arthroplasty: results of a multicenter prospective randomized study and update of the contemporary ceramic total hip trials in the United States.

Table 18.1  Advantages and disadvantages of different MIS surgical approaches
Table 18.1 Advantages and disadvantages of different MIS surgical approaches

Does a MIS technique lead to less blood loss?

With similar anesthetic protocols, the length of incision had little impact on patient recovery and length of stay. Similarly, postoperative narcotic use was not affected by incision length but was dependent on multimodal analgesia [overall quality: strong].

Does a MIS technique lead to better patient function?

Similarly, deBeer et al22 also found no beneficial effect on the smaller incision when used with the lateral groin approach.

Does a MIS technique lead to quicker recovery?

DC, demographic characteristics; FNF, femoral neck fracture; FU, continued; HD, hip dysplasia; HHS, Harris hip score; MI, mini-incision; OA, osteoarthritis; ON, osteonecrosis; PA, posttraumatic arthritis; RA, rheumatoid arthritis; SI, standard incision.

Table 18.2  Summary of clinical studies on MIS THR
Table 18.2 Summary of clinical studies on MIS THR

Does MIS THR have similar complication rates to standard approaches?

  • Are there patient factors that may be predictive of a periprosthetic femur fracture?
  • What classification system is effective in guiding treatment?
  • What is the optimal management and outcome of Vancouver type A fractures?
  • What is the optimal management and outcome of Vancouver type B fractures?
  • What is the optimal management of Vancouver type C fractures (intraoperative and postoperative)?

Frank Stinchfield Award: muscle damage after total hip arthroplasty performed with the two-incision and mini-posterior techniques. Mini-incision total hip arthroplasty: a prospective, controlled investigation with 5-year follow-up evaluation.

Are there patient factors that may be predictive of a periprosthetic femur

The incidence of periprosthetic fractures varies between 0.4 and 3.9% for all arthroplasties, depending on whether they occur in the primary or revision setting.1-3 These numbers have been steadily increasing over time as a function of the advancing age of the population. and the increasing use of total hip arthroplasty (THR). Taylor reports a series in which 80% of patients with periprosthetic fractures had osteoporosis.16 Wu et al.

Quality of the evidence Level IV

Gambar

Figure 2.1 Assigning grades of evidence by GRADE Working Group. (Reproduced from Grading quality of evidence and strength of recommendations,  Atkins D, Best D, Briss PA, et al, 328, 1490, 2004 with permission from BMJ Publishing Group Ltd.)
Figure 4.2  Using the medical literature to provide optimal patient care.
Table 4.2  Levels of evidence for therapeutic studies Level Therapeutic studies investigating the results of
Table 4.3  Levels of evidence for prognostic studies
+7

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