Evidence Based Orthopaedics- The Best Practice Standards Dr Hitesh Gopalan U Editor, Evidence Based Orthopaedic Principles Editor, www.orthopaedicprinciples.com Visiting Professor, McMaster University, Ontario, Canada Expert Advisor, OrthoEvidence SICOT India Scientific Chairman

Disclosures Nil

10 pathbreaking discoveries in last 500 years

Why EBM? One of the most highly searched medical word on Google Change in existing Practice

Hierarchy of Evidence Randomized Trials Prospective Cohort Studies Meta-analysis Randomized Trials Level 1 Prospective Cohort Studies Level 2 Level 3 Case Control Studies Retrospective Case Series Level 4 Opinion Level 5

Randomization Tx A Outcome R Patients Tx B Outcome Forward in Time

Randomized Trials Aren’t Always Practical or Feasible Ethical Issues “Is it ethical to randomize patients” Outcomes are too rare? “We’ll never be able to recruit so many patients!” Surgeon “buy in” Differential expertise The Primary Question Prognosis Cost We’ll never raise enough money to pull this off

Hierarchy of Evidence Randomized Trials Prospective Cohort Studies Level 1 Prospective Cohort Studies Level 2 Level 3 Case Control Studies Retrospective Case Series Level 4 Opinion Level 5

Cohort Study ? Forward in Time Exposed A Outcome Patients Exposed B

Hierarchy of Evidence Randomized Trials Prospective Cohort Studies Level 1 Prospective Cohort Studies Level 2 Level 3 Case Control Studies Retrospective Case Series Level 4 Opinion Level 5

Case-Control Study Backward in Time Infection Prognostic Factor Outcomes Infection Prognostic Factor Start Here No Infection Prognostic Factor Backward in Time

What is Evidence-based Medicine? conscientious requires clinical expertise current best evidence implies hierarchy of evidence health care decisions patient values

Hierarchy of Evidence Randomized Trials Prospective Cohort Studies Case Control Studies Retrospective Case Series Opinion

Hierarchy of Evidence Randomized Trials Prospective Cohort Studies Meta-analysis Randomized Trials Less Bias Level 1 Prospective Cohort Studies Level 2 Level 3 Case Control Studies Retrospective Case Series Level 4 Opinion Level 5 More Bias

Average No of Publications 6400 Across 64 pubmed Index Orthopaedic Journals

Countless Articles and Books Springer: 150 Orthopaedic books per year Thieme: another 50….

Big Data

Industry Funded Research Drug trials

VTE Prophylaxis ACCP Vs AAOS Debates: last 10 years LMWH, Dabigatran, Fondaparinux, Rivaroxaban, Apixaban Recent Addition: Aspirin + Mechanical Prophylaxis

Evidence Pyramid

AVN Femoral head

GRADE Recommendations High = Further research is very unlikely to change our confidence in the estimate of effect Moderate = Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate

High = Further research is very unlikely to change our confidence in the estimate of effect Moderate = Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate

GRADE Recommendations Low = Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate Atkins D, Best D, Briss PA, et al. Grading quality of evidence and strength of recommendations. BMJ 2004;328:1490.

AVN Hip Low = Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate

Downgrade Serious (-1) or very serious (-2) limitation to study quality Important inconsistency (-1) Some(-1) or major (-2) uncertainty about directness Imprecise or sparse data (-1) High probability of reporting bias

Levels of Evidence-2003

EBM: Who Discovered? Gordon Guyatt David Sackett(1934- 2015)

Navigated TKR Vs Conventional

Navigation 1mm deviation from mechanical axis Femoral and tibial component alignment as perfect as possible Cost Effectiveness??

Eminence Vs Evidence: Hi Flex 38% femoral component loosening Han HS, J Bone Joint Surg Br 2007 Nov;89(11):1457-61

Clavicle Trial Explosion in clavicle fracture ORIF Extended indications

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