Clinical trial NCT03131947: HIV in Orthopaedic Skeletal Trauma Study
Official title: HOST Study - HIV in Orthopaedic Skeletal Trauma Study; Fracture Healing in HIV-positive Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fracture Healing in HIV-positive Patients
Lead sponsor: Wellcome Trust Liverpool Glasgow Centre for Global Health Research
Sponsor class: OTHER
Collaborators: name: Professor David Lalloo
name: Professor Hamish Simpson
name: Professor William J Harrison
name: Professor Sithombo Maqungo
First posted: 2017-04-27
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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 will be potentially eligible for inclusion in the study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria;

* They are older than 18 years old
* Present to the GSH within 2 weeks of injury
* Sustained a closed or open fracture of tibia and femur fractures
* Undergo IM nailing for fracture fixation

Exclusion Criteria:

* Major head injury
* Pre-surgical infection at the fracture site
* Open injury for \>48 hours before the first debridement.
* Severe burns
* Pathological fracture
* There is evidence that the patient would be unable to adhere to study procedures, complete questionnaires or attend follow up.

Primary outcomes:
measure: Delayed fracture healing
timeFrame: 6 months
Secondary outcomes:
measure: Nonunion
timeFrame: 12 months
measure: Infection
timeFrame: 12 months
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
Study officials:
References:
citation: Graham SM, Maqungo S, Laubscher M, Ferreira N, Held M, Harrison WJ, Simpson AH, MacPherson P, Lalloo DG. Fracture Healing in Patients With HIV in South Africa: A Prospective Cohort Study. J Acquir Immune Defic Syndr. 2021 Aug 15;87(5):1214-1220. doi: 10.1097/QAI.0000000000002720.