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
Highlights
Worldwide approximately 35.3 million people are Human immunodeficiency virus (HIV) positive, with the highest prevalence seen in sub-Saharan Africa.[1]
These have suggested that HIV and/ or antiretroviral therapy (ART) are associated with delayed fracture healing and may result in non-union.[11,18]
De-identified data will be exported for analysis. This is the largest study of its type to assess the effect of HIV and ART on bone healing
Summary
Worldwide approximately 35.3 million people are HIV positive, with the highest prevalence seen in sub-Saharan Africa.[1] The introduction of antiretroviral therapy (ART) in 1997 has altered the course and nature of patients infected with HIV by increasing the duration of asymptomatic infection, and patients with HIV are attaining close-to-normal life spans Despite these longer life expectancies, there is little evidence to advise the surgeon and patient about the effect of long-term immunosuppression on the fracture repair process in orthopaedic surgery.[2]. A small number of studies have investigated the role of HIV in the fracture-healing process These have suggested that HIV and/ or ART are associated with delayed fracture healing and may result in non-union.[11,18] The molecular and cellular mechanisms driving this process remain unclear and the true effect of HIV and ART on bone healing is very poorly understood. Of life after fracture healing following IM nailing fracture surgery in HIV-positive and-negative patients
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