HIV in Orthopaedic Skeletal Trauma Study

• Conditions: Fracture Healing in HIV-positive Patients

• Registration Number: NCT03131947
• Lead Sponsor: Wellcome Trust Liverpool Glasgow Centre for Global Health Research

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.

Study Timeline

• Study First Submitted: 2017-04-24
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-27
• Study Start: 2017-09-28
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-21
• Last Update Posted: 2018-05-22
• Primary Completion: 2019-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delayed fracture healing	6 months	Incidence of delayed bone union in patients treated at GSH in HIV positive and negative patients

Secondary Outcome Measures

Name	Time	Method
Nonunion	12 months	Incidence of nonunion in patients treated at GSH in HIV positive and negative patients
Infection	12 months	Incidence of superficial, deep and late wound infections in patients treated at GSH in HIV positive and negative patients

Trial Locations

Locations (1)

Groote Schuur Hospital; 🇿🇦 Cape Town, South Africa