HIV in Orthopaedic Skeletal Trauma Study (HOST)

May 21, 2018 updated by: John Spafford, Wellcome Trust Liverpool Glasgow Centre for Global Health Research

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Union
Radiological union on RUST score (figure 2) (score of 3 on at least 3 cortices in AP, lateral, medial or posterior cortex - total of 9 or more) within 6 months of surgery
Other: HIV positive patients
As above
Other Names:
  • No intervention, patients undergo standard surgery for their fracture management.
Delayed union
Impaired bone healing at six months (RUST score < 9)
Other: HIV positive patients
As above
Other Names:
  • No intervention, patients undergo standard surgery for their fracture management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delayed fracture healing
Time Frame: 6 months
Incidence of delayed bone union in patients treated at GSH in HIV positive and negative patients
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nonunion
Time Frame: 12 months
Incidence of nonunion in patients treated at GSH in HIV positive and negative patients
12 months
Infection
Time Frame: 12 months
Incidence of superficial, deep and late wound infections in patients treated at GSH in HIV positive and negative patients
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wellcome Trust Liverpool Glasgow Centre for Global Health Research

Collaborators

Professor David Lalloo
Professor Hamish Simpson
Professor William J Harrison
Professor Sithombo Maqungo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2017

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

April 24, 2017

First Posted (Actual)

April 27, 2017

Study Record Updates

Last Update Posted (Actual)

May 22, 2018

Last Update Submitted That Met QC Criteria

May 21, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOST STUDY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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