HOST Study – HIV in Orthopaedic Skeletal Trauma Study: protocol for a multicentre case-cohort study

Authors

  • Simon Matthew Graham
  • W J Harrison Countess of Chester Hospital
  • D G Lalloo
  • A H Simpson University of Edinburgh
  • M Laubscher University of Cape Town
  • M Held University of Cape Town
  • N Ferreira Stellenbosch University
  • S Maqungo University of Cape Town

Keywords:

antiretroviral therapy, fracture, femur, human immunodeficiency virus, intramedullary nail, tibia

Abstract

Background: Human immunodeficiency virus (HIV) and antiretroviral therapy (ART) have both been shown to reduce bone mineral density, mineralisation and bone turnover. Our study group and other researchers have suggested that HIV may impair fracture healing, based on extrapolation from basic science. These observations prompted this study as the true effect of HIV and highly active antiretroviral therapy (HAART) on bone healing is very poorly understood and has not previously been investigated.

Methods: HOST Study is a multicentre case-cohort study being undertaken at two orthopaedic trauma centres in Cape Town, South Africa. All adult patients older than 18 years with fresh (within 2 weeks of injury), closed and open, tibia and femur fractures who undergo intramedullary (IM) nailing for fracture fixation will be eligible or the study. Participants will be recruited over 24 months and undergo a baseline questionnaire, HIV testing and assessment of their bone mineral density (BMD). They will be followed up at 2 and 6 weeks, and at 3, 6, 9 and 12 months. All adult patients who develop delayed bone union at the 6-month follow-up will be considered cases. Adult patients who show evidence of radiological union at 6 months or less will be considered controls. We will then determine if HIV is a risk factor for the development of delayed bone union. HIV prevalence levels in the cases and controls will be summarised using IRR (incidence rate ratio) statistics with their 95% confidence intervals. Negative binomial regression methodswill be used to adjust the IRR estimates for the possible effects of confounding factors and/or important covariates.

Results: Outcomes from the primary manuscript will be disseminated through publications in academic journals and presentations at relevant orthopaedic conferences. We will communicate trial results to all participating sites. Participating sites will communicate results with patients who have indicated an interest in knowing the results.

Trial registration number: ClinicalTrials.gov - NCT03131947

Site of study: Groote Schuur Hospital and Tygerberg Hospital, Cape Town, South Africa

Author Biographies

Simon Matthew Graham

Orthopaedic Trauma and Wellcome Trust Clinical Research Fellow, Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom; and Department of Orthopaedic Surgery, University of Edinburgh, United Kingdom

W J Harrison, Countess of Chester Hospital

Consultant orthopaedic surgeon, Countess of Chester Hospital, Chester

D G Lalloo

Professor and Dean of Clinical Sciences and International Public Health, Chair in Tropical Medicine, Director Wellcome Trust Liverpool Glasgow Centre for Global Health Research, Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool; and Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi

A H Simpson, University of Edinburgh

Professor of Orthopaedics and Trauma, and consultant orthopaedic surgeon, Department of Orthopaedic Surgery, University of Edinburgh, Edinburgh

M Laubscher, University of Cape Town

Consultant orthopaedic surgeon, Orthopaedic Research Unit, Department of Orthopaedic Surgery, Groote Schuur Hospital, University of Cape Town, Cape Town

M Held, University of Cape Town

Consultant orthopaedic surgeon, Orthopaedic Research Unit, Department of Orthopaedic Surgery, Groote Schuur Hospital, University of Cape Town, Cape Town

N Ferreira, Stellenbosch University

Associate Professor and Head Clinical Unit, Tumour, Sepsis and Reconstruction, Division of Orthopaedics and Department of Surgical Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University

S Maqungo, University of Cape Town

Professor and Head, Orthopaedic Trauma Service, Orthopaedic Research Unit, Department of Orthopaedic Surgery, Groote Schuur Hospital, University of Cape Town, Cape Town

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Published

2018-07-24

Issue

Vol 17 No 3 (2018): Spring 2018

Section

Research Protocol

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