HIV in Orthopaedic Skeletal Trauma Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-28

Study Completion Date

2019-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Retrospective Study to Determine the Incidence of Bone Fractures in HIV-infected Patients in Spain

NCT02045537

HIV

UNKNOWN

Prevalence of Vertebral Fractures in HIV Infected Patients Older Than 50 Years

NCT02131571

Vertebral Fractures

COMPLETED

Trochanteric Hip Fractures (AO A2) SHS With or Without Trochanteric Stabilizing Plate - Rct Using RSA

NCT02294747

Hip Fractures Trochanteric Fractures Intertrochanteric Fractures

COMPLETED NA

Hip Fracture in Individuals Under 60 Years of Age

NCT03848195

Hip Fractures

COMPLETED

Patient Experience of Acute Rehabilitation After Hip Fracture

NCT03224195

Hip Fractures Fracture of Hip Fractured Hip

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fracture Healing in HIV-positive Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

HIV positive patients

Intervention Type OTHER

As above

Delayed union

Impaired bone healing at six months (RUST score \< 9)

HIV positive patients

Intervention Type OTHER

As above

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HIV positive patients

As above

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

No intervention, patients undergo standard surgery for their fracture management.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No