Experience from the Swedish Fracture Register Olof Wolf Co Director Swedish Fracture Register Department of Orthopaedics Uppsala University Hospital Sweden Swedish Fracture ID: 1047881
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1. Register Nested Trials Experience from the Swedish Fracture RegisterOlof WolfCo DirectorSwedish Fracture RegisterDepartment of OrthopaedicsUppsala University Hospital, Sweden
2. Swedish Fracture RegisterStarted 2011 fully developed 2015All fracture types in one nationwide fracture registerSurgical and non-surgical treatment100% coverage since 2021Increasing completeness >65% for all fractures >80 for hip fractures
3. Swedish Fracture RegisterWeb based registration by surgeonsFractures classification AO/OTAInjury mechanism and treatment registered Classification of pathological, periprosthetic, open fractures
4. Demonstration of the Swedish Fracture Register
5. Web based
6. Personal identity number is the keyName in real time from the Swedish Population RegisterPossible to link to other registers
7. Injury mechanismDateCauseLocationLow/high energy
8. Fracture characteristics
9. Fracture classification
10.
11. Treatment detailsTypeMethodSurgeon level
12. External fixationSubsequent reoperation added to initial fracturePROM (EQ5D and SMFA) pre-injury and 1-yearFull primary registration
13. > 50 Publications
14. What kind of research is good research?Multicenter RCTs100 patients, eg DASH scorePragmatic multicenter RCTsProFHER: 1250 screened, 250 includedRegister studies1,000?10,000?… 100,000?Why not combine them all?
15. Registerbased RCTUse the Register to find the patients Inclusion criteria defined External validityConstruct a study platform Screening/Eligibility RandomisationOutcome – no follow-up (easiest) Retrieve from SFR or other registers Mortality? Reoperations?
16. HIPSTHERHip Screws or (Total) Hip Replacement for undisplaced femoral neck fractures in elderly patients
17. Primary OutcomeComposite variable comprising Reoperation rate & Mortality
18. Hipsther set upNo follow up visits!Mortality and reoperations registered in the SFRReoperations linked with The Swedish Hip Arthroplasty Register The National Patient Register Patient reported outcome in SFR
19. Hipsther Study Platform
20. Injury Mechanism
21. Fracture Characteristics
22. Fracture Characteristics
23. Inclusion criteria recognised by platformThe patient fulfills the inclusion criteria for the Hipsther study? Do you want to screen the patient now?> 75 yearsuFNF< 3 days
24. Screening questionsHas the patient already received treatment for the fracture?Is the patient fit for both procedures?Does the department have the resources for both procedures?Has the patient given informed consent?
25. Patient included and randomisedParticipating sites can choose:Prosthesis (make, fixation, type Hemi or Total) Osteosynthesis (screws/nails, 2-3)
26. Hipsther so far. 30 sites. 877 patients
27. Inclusion:Patient ≥65 years with displaced FNFTotal Hip replacementDuality-studyPI Prof N.P. HailerRandomization:Standard Cup or Dual Mobility Cup?
28. Duality 1082 /1600 patients
29. Thoracolumbar burst fracturesNon operative vs operative treatment79/202 patients randomizedPI Prof P. Gerdhem
30. Experiences rRCTs in the SFRPersonal identity number enables linking registers for outcomeNo research unit needed at local hospital small regional – University Hospitals60% hospitals active in Hipsther, 40% in DualityOnly add-on is consent and preoperative registration, screening and randomzationNational funding to Hipsther, Duality and SunBurst
31. ProblemsRegister maintenance study platform downStudy site activity recurrent presentations/information no local exclusion criteriaInclusion and consent hip fractures? vs elective? Start-up meeting/information study platform only active in study sitesInclusion rate monthly feedbackRecurrent study meetings local investigatorsLocal monitoring Solutions?
32. Future perspectiveStudy Platform worksRandomisation Preoperative (blocks, nutrition) Postoperative regime (weight bearing, pain medication, anticoagulants, antiresorptive medication)Olof.wolf@surgsci.uu.se