Fracture Healing in HIV-positive PatientsHOSTNCT03131947
HIV in Orthopaedic Skeletal Trauma Study
An observational study of Fracture Healing in HIV-positive Patients, run by Wellcome Trust Liverpool Glasgow Centre for Global Health Research at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture Healing in HIV-positive Patients
- What is being tested?
- HIV positive patients
- How many people
- 420 participants
- Where
- 1 siteSouth Africa
- Study dates
- 28 Sep 2017to Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Africa1 site, 1 recruiting
- Recruiting
Groote Schuur Hospital
Cape Town
Simon Graham, MBChB, simonmatthewgraham@doctors.org.uk
About this study
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.
Read the detailed description
- Primary research question Does Human Immunodeficiency Virus (HIV) alter the fracture repair process?
- Aim To establish whether HIV is a risk factor for the development of delayed bone union or nonunion following a fracture.
- Study
- Setting Orthopaedic and Trauma Department, Groote Schuur Hospital (GSH), Cape Town, South Africa.
- Study design Case-cohort study of patients undergoing fracture surgery at GSH, Cape Town, South Africa.
- 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.
- 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.
- Being tested
- HIV positive patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV positive patientsOther
Also called No intervention, patients undergo standard surgery for their fracture management.
As above
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: HIV positive patients | |
| Delayed union | Impaired bone healing at six months (RUST score < 9) Receives: Other: HIV positive patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed fracture healing
Incidence of delayed bone union in patients treated at GSH in HIV positive and negative patients
Measured: 6 months
Secondary outcomes (2)
Nonunion
Incidence of nonunion in patients treated at GSH in HIV positive and negative patients
Measured: 12 months
Infection
Incidence of superficial, deep and late wound infections in patients treated at GSH in HIV positive and negative patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start28 Sep 2017
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fracture Healing in HIV-positive PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wellcome Trust Liverpool Glasgow Centre for Global Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Professor David Lalloo, Professor Hamish Simpson, Professor William J Harrison, Professor Sithombo Maqungo
- Responsible party
- Principal investigator, John Spafford, Wellcome Trust Liverpool Glasgow Centre for Global Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131947
- Sponsor's protocol ID
- HOST STUDY
- Acronym
- HOST
- Status last verified
- May 2018
- First submitted
- 24 Apr 2017
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33990496
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOST Study - HIV in Orthopaedic Skeletal Trauma Study; Fracture Healing in HIV-positive Patients
- ClinicalTrials.gov ID
- NCT03131947
- Acronym / sponsor ID
- HOST / HOST STUDY
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Wellcome Trust Liverpool Glasgow Centre for Global Health ResearchUniversity, hospital or other
- Collaborators
- Professor David Lalloo, Professor Hamish Simpson, Professor William J Harrison, Professor Sithombo Maqungo
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary research question Does Human Immunodeficiency Virus (HIV) alter the fracture repair process?
- Aim To establish whether HIV is a risk factor for the development of delayed bone union or nonunion following a fracture.
- Study
- Setting Orthopaedic and Trauma Department, Groote Schuur Hospital (GSH), Cape Town, South Africa.
- Study design Case-cohort study of patients undergoing fracture surgery at GSH, Cape Town, South Africa.
- 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.
- 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Union | – | Other: HIV positive patientsRadiological 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 |
| Delayed union | – | Other: HIV positive patientsImpaired bone healing at six months (RUST score < 9) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Major head injury
- Pre-surgical infection at the fracture site
- Open injury for >48 hours before the first debridement.
- Severe burns
- Pathological fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV positive patientsAlso: No intervention, patients undergo standard surgery for their fracture management.As above | Other | Delayed union, Union |
Primary outcome
Delayed fracture healing
Time frame: 6 months
Incidence of delayed bone union in patients treated at GSH in HIV positive and negative patients
2 secondary outcomes
Nonunion
Time frame: 12 months
Infection
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Derived from this study: PubMed 33990496Graham 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture Healing in HIV-positive Patients, run by Wellcome Trust Liverpool Glasgow Centre for Global Health Research at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon M Graham, MBChB, MRCS, MSc, FRCS (447793962393, simonmatthewgraham@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed fracture healing (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03131947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018.