HIV in Orthopaedic Skeletal Trauma Study

Fracture Healing in HIV-positive Patients Clinical Trial

— HOST  

Official title:

HOST Study - HIV in Orthopaedic Skeletal Trauma Study; Fracture Healing in HIV-positive Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03131947
• Other study ID #: HOST STUDY
• Status: Recruiting
• Start date: September 28, 2017
• Est. completion date: August 2019

Study information

• Verified date: May 2018
• Source: Wellcome Trust Liverpool Glasgow Centre for Global Health Research
• Contact: Simon M Graham, MBChB, MRCS, MSc, FRCS
• Phone: 447793962393
• Email: simonmatthewgraham[@]doctors.org.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fracture Healing in HIV-positive Patients
• HIV Seropositivity

Intervention

Other:
• HIV positive patients
As above

Locations

Country	Name	City	State
South Africa	Groote Schuur Hospital	Cape Town

Sponsors (5)

Lead Sponsor	Collaborator
Wellcome Trust Liverpool Glasgow Centre for Global Health Research	Professor David Lalloo, Professor Hamish Simpson, Professor Sithombo Maqungo, Professor William J Harrison

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delayed fracture healing	Incidence of delayed bone union in patients treated at GSH in HIV positive and negative patients	6 months
Secondary	Nonunion	Incidence of nonunion in patients treated at GSH in HIV positive and negative patients	12 months
Secondary	Infection	Incidence of superficial, deep and late wound infections in patients treated at GSH in HIV positive and negative patients	12 months