PMID- 33196584 OWN - NLM STAT- MEDLINE DCOM- 20210830 LR - 20230814 IS - 1528-1132 (Electronic) IS - 0009-921X (Print) IS - 0009-921X (Linking) VI - 479 IP - 4 DP - 2021 Apr 1 TI - Smoking, Obesity, and Disability Benefits or Litigation Are Not Associated with Clinically Important Reductions in Physical Functioning After Intramedullary Nailing of Tibial Shaft Fractures: A Retrospective Cohort Study. PG - 805-813 LID - 10.1097/CORR.0000000000001573 [doi] AB - BACKGROUND: Forty percent of long bone fractures involve the tibia. These fractures are associated with prolonged recovery and may adversely affect patients' long-term physical functioning; however, there is limited evidence to inform what factors influence functional recovery in this patient population. QUESTION/PURPOSE: In a secondary analysis of a previous randomized trial, we asked: What fracture-related, demographic, social, or rehabilitative factors were associated with physical function 1 year after reamed intramedullary nailing of open or closed tibial shaft fractures? METHODS: This is a secondary (retrospective) analysis of a prior randomized trial (Trial to Re-evaluate Ultrasound in the Treatment of Tibial Fractures; TRUST trial). In the TRUST trial, 501 patients with unilateral open or closed tibial shaft fractures were randomized to self-administer daily low-intensity pulsed ultrasound or use a sham device, of which 15% (73 of 501) were not followed for 1 year due to early study termination as a result of futility (no difference between active and sham interventions). Of the remaining patients, 70% (299 of 428) provided full data. All fractures were fixed using reamed (298 of 299) or unreamed (1 of 299) intramedullary nailing. Thus, we excluded the sole fracture fixed using unreamed intramedullary nailing. The co-primary study outcomes of the TRUST trial were time to radiographic healing and SF-36 physical component summary (SF-36 PCS) scores at 1-year. SF-36 PCS scores range from 0 to 100, with higher scores being better, and the minimum clinically important difference (MCID) is 5 points. In this secondary analysis, based on clinical and biological rationale, we selected factors that may be associated with physical functioning as measured by SF-36 PCS scores. All selected factors were inserted simultaneously into a multivariate linear regression analysis. RESULTS: After adjusting for potentially confounding factors, such as age, gender, and injury severity, we found that no factor showed an association that exceeded the MCID for physical functioning 1 year after intramedullary nailing for tibial shaft fractures. The independent variables associated with lower physical functioning were current smoking status (mean difference -3.0 [95% confidence interval -5 to -0.5]; p = 0.02), BMI > 30 kg/m2 (mean difference -3.0 [95% CI -5.0 to -0.3]; p = 0.03), and receipt of disability benefits or involvement in litigation, or plans to be (mean difference -3.0 [95% CI -5.0 to -1]; p = 0.007). Patients who were employed (mean difference 4.6 [95% CI 2.0 to 7]; p < 0.001) and those who were advised by their surgeon to partially or fully bear weight postoperatively (mean difference 2.0 [95% CI 0.1 to 4.0]; p = 0.04) were associated with higher physical functioning. Age, gender, fracture severity, and receipt of early physical therapy were not associated with physical functioning at 1-year following surgical fixation. CONCLUSION: Among patients with tibial fractures, none of the factors we analyzed, including smoking status, receipt of disability benefits or involvement in litigation, or BMI, showed an association with physical functioning that exceeded the MCID. LEVEL OF EVIDENCE: Level III, therapeutic study. CI - Copyright (c) 2020 by the Association of Bone and Joint Surgeons. FAU - Findakli, Fawaz AU - Findakli F AD - F. Findakli, J. W. Busse, F. Farrokhyar, M. Bhandari, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. AD - J. W. Busse, Department of Anesthesia, McMaster University, Hamilton, ON, Canada. AD - J. W. Busse, Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, ON, Canada. AD - J. W. Busse, The Canadian Veterans Chronic Pain Centre of Excellence, Hamilton, ON, Canada. AD - E. H. Schemitsch, Department of Surgery, University of Western Ontario, London, ON, Canada. AD - E. Lonn, Population Health Research Institute, McMaster University, Hamilton, ON, Canada. AD - M. Bhandari, Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada. FAU - Busse, Jason W AU - Busse JW AD - F. Findakli, J. W. Busse, F. Farrokhyar, M. Bhandari, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. AD - J. W. Busse, Department of Anesthesia, McMaster University, Hamilton, ON, Canada. AD - J. W. Busse, Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, ON, Canada. AD - J. W. Busse, The Canadian Veterans Chronic Pain Centre of Excellence, Hamilton, ON, Canada. AD - E. H. Schemitsch, Department of Surgery, University of Western Ontario, London, ON, Canada. AD - E. Lonn, Population Health Research Institute, McMaster University, Hamilton, ON, Canada. AD - M. Bhandari, Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada. FAU - Schemitsch, Emil H AU - Schemitsch EH AD - F. Findakli, J. W. Busse, F. Farrokhyar, M. Bhandari, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. AD - J. W. Busse, Department of Anesthesia, McMaster University, Hamilton, ON, Canada. AD - J. W. Busse, Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, ON, Canada. AD - J. W. Busse, The Canadian Veterans Chronic Pain Centre of Excellence, Hamilton, ON, Canada. AD - E. H. Schemitsch, Department of Surgery, University of Western Ontario, London, ON, Canada. AD - E. Lonn, Population Health Research Institute, McMaster University, Hamilton, ON, Canada. AD - M. Bhandari, Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada. FAU - Lonn, Eva AU - Lonn E AD - F. Findakli, J. W. Busse, F. Farrokhyar, M. Bhandari, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. AD - J. W. Busse, Department of Anesthesia, McMaster University, Hamilton, ON, Canada. AD - J. W. Busse, Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, ON, Canada. AD - J. W. Busse, The Canadian Veterans Chronic Pain Centre of Excellence, Hamilton, ON, Canada. AD - E. H. Schemitsch, Department of Surgery, University of Western Ontario, London, ON, Canada. AD - E. Lonn, Population Health Research Institute, McMaster University, Hamilton, ON, Canada. AD - M. Bhandari, Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada. FAU - Farrokhyar, Forough AU - Farrokhyar F AD - F. Findakli, J. W. Busse, F. Farrokhyar, M. Bhandari, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. AD - J. W. Busse, Department of Anesthesia, McMaster University, Hamilton, ON, Canada. AD - J. W. Busse, Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, ON, Canada. AD - J. W. Busse, The Canadian Veterans Chronic Pain Centre of Excellence, Hamilton, ON, Canada. AD - E. H. Schemitsch, Department of Surgery, University of Western Ontario, London, ON, Canada. AD - E. Lonn, Population Health Research Institute, McMaster University, Hamilton, ON, Canada. AD - M. Bhandari, Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada. FAU - Bhandari, Mohit AU - Bhandari M AD - F. Findakli, J. W. Busse, F. Farrokhyar, M. Bhandari, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada. AD - J. W. Busse, Department of Anesthesia, McMaster University, Hamilton, ON, Canada. AD - J. W. Busse, Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, ON, Canada. AD - J. W. Busse, The Canadian Veterans Chronic Pain Centre of Excellence, Hamilton, ON, Canada. AD - E. H. Schemitsch, Department of Surgery, University of Western Ontario, London, ON, Canada. AD - E. Lonn, Population Health Research Institute, McMaster University, Hamilton, ON, Canada. AD - M. Bhandari, Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada. CN - and the TRUST Investigators LA - eng SI - ClinicalTrials.gov/NCT00667849 PT - Journal Article PL - United States TA - Clin Orthop Relat Res JT - Clinical orthopaedics and related research JID - 0075674 SB - IM CIN - Clin Orthop Relat Res. 2021 Apr 1;479(4):814-816. PMID: 33394607 MH - Adult MH - Female MH - *Fracture Fixation, Intramedullary/adverse effects MH - Fracture Healing MH - Functional Status MH - Humans MH - *Insurance, Disability MH - *Jurisprudence MH - Male MH - Middle Aged MH - *Minimal Clinically Important Difference MH - Obesity/*complications/diagnosis MH - Randomized Controlled Trials as Topic MH - Recovery of Function MH - Retrospective Studies MH - Risk Assessment MH - Risk Factors MH - Smoking/*adverse effects MH - Tibial Fractures/complications/diagnostic imaging/physiopathology/*surgery MH - Time Factors MH - Treatment Outcome MH - Ultrasonic Waves MH - Young Adult PMC - PMC8083930 COIS- All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research(R) editors and board members are on file with the publication and can be viewed on request. Each author certifies that neither he nor she, nor any member of his or her immediate family, has funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article. EDAT- 2020/11/17 06:00 MHDA- 2021/08/31 06:00 PMCR- 2022/04/01 CRDT- 2020/11/16 14:48 PHST- 2019/09/30 00:00 [received] PHST- 2020/10/19 00:00 [accepted] PHST- 2020/11/17 06:00 [pubmed] PHST- 2021/08/31 06:00 [medline] PHST- 2020/11/16 14:48 [entrez] PHST- 2022/04/01 00:00 [pmc-release] AID - 00003086-202104000-00031 [pii] AID - CORR-D-19-01362 [pii] AID - 10.1097/CORR.0000000000001573 [doi] PST - ppublish SO - Clin Orthop Relat Res. 2021 Apr 1;479(4):805-813. doi: 10.1097/CORR.0000000000001573.