Fracture Healing in HIV-positive Patients Clinical Trial
Official title:
HOST Study - HIV in Orthopaedic Skeletal Trauma Study; Fracture Healing in HIV-positive Patients
Adult patients > 18 years with fresh (within 2 weeks of injury), closed and open, tibia and femur fractures who undergo IM nailing for fracture fixation will be eligible for the study. Participants will be recruited over 24 months. Participants will undergo a baseline questionnaire, HIV testing and assessment of their BMD. They will be followed up at 6 weeks, and 3, 6 and 12 months. All adult patients who develop delayed bone union at 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.
1. Primary research question Does Human Immunodeficiency Virus (HIV) alter the fracture
repair process?
2. Aim To establish whether HIV is a risk factor for the development of delayed bone union
or nonunion following a fracture.
3. Study
1. Setting Orthopaedic and Trauma Department, Groote Schuur Hospital (GSH), Cape Town,
South Africa.
2. Study design Case-cohort study of patients undergoing fracture surgery at GSH, Cape
Town, South Africa.
3. Study population Adult patients > 18 years with fresh (within 2 weeks of injury),
closed and open, tibia and femur fractures who undergo intramedullary (IM) nailing
for fracture fixation.
4. Study summary Adult patients > 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 potentially eligible for inclusion in the study.
Participants will undergo a baseline questionnaire, assessment of their HIV status
and measurement of their bone mineral density (BMD) using a Dual Energy X-ray
Absorbometry (DEXA) Heel Scanner.
Participants will be followed up at 2 weeks, and 3, 6 and 12 months. X-rays will be performed
at 3, 6 and 12 months. Bone healing will be assessed using a validated X-ray scoring system -
the Radiological Union Scoring system for the Tibia (RUST scoring system).(19), (20) An
independent observer blinded to HIV status will assess radiological fracture union.
Participants will be recruited over 24 months.
All adult patients treated at GSH with IM nailing of the tibia or femur and develop delayed
bone union at 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.
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