HIV in Orthopaedic Skeletal Trauma Study | NCT03131947

Studies
HIV in Orthopaedic Skeletal Trauma Study

NCT03131947

Sponsor

Wellcome Trust Liverpool Glasgow Centre for Global Health Research

Status

Unknown status

Last Update Posted

May 22, 2018Actual

Enrollment

420Estimated

Phase

Not provided

Conditions

Fracture Healing in HIV-positive Patients

Interventions

HIV positive patients

Countries

South Africa

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 28, 2017Actual

Primary Completion Date

Aug 2019Estimated

Completion Date

Aug 2019Estimated

First Submitted Date

Apr 24, 2017

First Submission Date that Met QC Criteria

Apr 24, 2017

First Posted Date

Apr 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2018

Last Update Posted Date

May 22, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

John Spafford, Wellcome Trust Clinical Research and Training Fellow, Wellcome Trust Liverpool Glasgow Centre for Global Health ResearchPrincipal Investigator

Lead Sponsor

Wellcome Trust Liverpool Glasgow Centre for Global Health ResearchOTHER

Collaborators

Name	Class
Professor David Lalloo	UNKNOWN
Professor Hamish Simpson	UNKNOWN
Professor William J Harrison	UNKNOWN
Professor Sithombo Maqungo

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

420Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
Delayed union		Impaired bone healing at six months (RUST score < 9)	Other: HIV positive patients

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HIV positive patients	Other	As above	Delayed union Union

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Simon M Graham, MBChB, MRCS, MSc, FRCS	Contact	447793962393		simonmatthewgraham@doctors.org.uk
Sithombo Maqungo	Contact	447793962393		sithombo@msn.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groote Schuur Hospital	Recruiting	Cape Town			South Africa

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33990496	Derived	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.