Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000312741
Ethics application status
Approved
Date submitted
13/02/2022
Date registered
18/02/2022
Date last updated
11/05/2025
Date data sharing statement initially provided
18/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hip fracture surgery and outcomes
Scientific title
Hip Fracture Cohort Study Linking Obesity to Thromboembolism post-Surgery
Secondary ID [1] 306410 0
Nil known
Universal Trial Number (UTN)
U1111-1274-3365
Trial acronym
HipCLOTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip fracture surgery complications 325245 0
Condition category
Condition code
Surgery 322642 322642 0 0
Other surgery
Blood 322644 322644 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Exposure: High or low body mass index (BMI) ( WHO classification) in hip fracture patients undergoing surgical fixation between January 2010 till 31 December 2020
The Prince Charles Hospital (TPCH) Hip Fracture unit was established in 2010 and manages approximately 350 hip fracture surgeries on average every year. Since 2015, Australian New Zealand Hip fracture registry (ANZHFR) was established as a collaborative project between societies with an aim to use the collected data to improve the outcomes through appropriate research. For this data linkage study, details of the patients that underwent hip fracture surgery at TPCH over a 10-year period (2010-2020) will be collected from various sources as below:

Hospital admission records (TPCH orthopaedic department database) would contain information on demographics (age, gender, body height, weight, BMI, other nutritional assessment measures as available, namely from malnutritional screening tool, subjective global assessment score), comorbidities (history of venous thromboembolism (VTE), chronic obstructive pulmonary disease (COPD), congestive cardiac failure (CCF), coronary artery disease (CAD), Peripheral vascular disease, chronic kidney disease (CKD), dyslipidaemia, Obstructive sleep apnoea (OSA,) hypertension (HTN), diabetes mellitus (DM), liver and renal disease, smoking status, presence of cancer, treatment with opioids, anticoagulants, antibiotics, immunosuppression, presence of metabolic syndrome (MetS), laboratory parameters including serum albumin, functional status, American Society of Anaesthesiologists (ASA) classification, thromboprophylactic regimen, intraoperative details including tranexamic acid, time to surgery, time to mobilise and postoperative discharge details including length of hospital stay, intensive care unit stay, mortality and complications. MetS will be defined according to the International Diabetes Federation definition as obesity (BMI >30 kg/m2) + any two of raised triglycerides, reduced high density lipoprotein (HDL) cholesterol, raised blood pressure, raised fasting plasma glucose or their alternatives as described.
Intervention code [1] 322839 0
Not applicable
Comparator / control treatment
Hip fracture patients with normal BMI ( 19-29.9 kg/m2) ( WHO classification undergoing surgical fixation will be the control group
Control group
Active

Outcomes
Primary outcome [1] 330441 0
Primary outcome: Thromboembolic complications (venous and arterial) : myocardial infarction, symptomatic deep venous thrombosis, pulmonary embolism, ischaemic stroke. Diagnosis and complication codes are classified using the International Classification of Diseases, 10th Revision, Australian Modification (ICD-10-AM)33 and retreived from the Qld Hospital Admitted Patient Data Collection (QHAPDC).. Individual charts would be reviewed for missing or ambiguous information. Records of ED presentation, complications will be retrieved through Australian New Zealand Hip fracture registry (ANZHFR), Occurrence of postoperative complication will be retrieved from the orthopaedic database from regular follow up, ANZ HFR and QH Statistical service branch (SSB) data linkage facility for readmissions from QHAPDC, ED presentations (Non-Hospital Admitted Patient Data Repository, NHAPDR), Clinic appointments for QH (public services) throughout the state
Timepoint [1] 330441 0
at 90 days following hip fracture surgery.
Secondary outcome [1] 406230 0
Thromboembolic complications and other complications (surgical site infection (SSI), major bleeding and transfusion, pneumonia, acute renal failure, mechanical complication, readmission and reoperation, intensive care unit admission, re-presentation to a hospital, cardiovascular death and non-fatal cardiac arrest) including mortality Diagnosis and complication codes are classified using the International Classification of Diseases, 10th Revision, Australian Modification (ICD-10-AM)33 and retreived from the Qld Hospital Admitted Patient Data Collection (QHAPDC).. Individual charts would be reviewed for missing or ambiguous information. Records of ED presentation, complications will be retrieved through Australian New Zealand Hip fracture registry (ANZHFR), Occurrence of postoperative complication will be retrieved from the orthopaedic database from regular follow up, ANZ HFR and QH Statistical service branch (SSB) data linkage facility for readmissions from QHAPDC, ED presentations (Non-Hospital Admitted Patient Data Repository, NHAPDR), Clinic appointments for QH (public services) throughout the state and Mortality from Queensland Births Deaths and Marriages registry (QBDMR). For non-Queensland residents who were operated at TPCH during the study period, where mortality may not be recorded in the QBDMR, mortality status will initially be ascertained through the electronic records linkage to retrieve date of last episode of care within the follow-up period, including admitted, and non-admitted episodes and clinic appointments in the public health system via the QH Statistical Services Branch. In addition, their paper medical record or their Viewer record may be assessed for details such as test results or clinical notes relating to relevant outcomes of interest.
Timepoint [1] 406230 0
Date of surgery (Day 1) till the Date of discharge
Secondary outcome [2] 406231 0
Thromboembolic complications and other complications (surgical site infection (SSI), major bleeding and transfusion, pneumonia, acute renal failure, mechanical complication, readmission and reoperation, intensive care unit admission, re-presentation to a hospital, cardiovascular death and non-fatal cardiac arrest) including mortality Diagnosis and complication codes are classified using the International Classification of Diseases, 10th Revision, Australian Modification (ICD-10-AM)33 and retreived from the Qld Hospital Admitted Patient Data Collection (QHAPDC).. Individual charts would be reviewed for missing or ambiguous information. Records of ED presentation, complications will be retrieved through Australian New Zealand Hip fracture registry (ANZHFR), Occurrence of postoperative complication will be retrieved from the orthopaedic database from regular follow up, ANZ HFR and QH Statistical service branch (SSB) data linkage facility for readmissions from QHAPDC, ED presentations (Non-Hospital Admitted Patient Data Repository, NHAPDR), Clinic appointments for QH (public services) throughout the state and Mortality from Queensland Births Deaths and Marriages registry (QBDMR). For non-Queensland residents who were operated at TPCH during the study period, where mortality may not be recorded in the QBDMR, mortality status will initially be ascertained through the electronic records linkage to retrieve date of last episode of care within the follow-up period, including admitted, and non-admitted episodes and clinic appointments in the public health system via the QH Statistical Services Branch. In addition, their paper medical record or their Viewer record may be assessed for details such as test results or clinical notes relating to relevant outcomes of interest.
Timepoint [2] 406231 0
Date of discharge to Day 137 (with the notional midpoint being Day 90)
Secondary outcome [3] 406232 0
Thromboembolic complications and other complications (surgical site infection (SSI), major bleeding and transfusion, pneumonia, acute renal failure, mechanical complication, readmission and reoperation, intensive care unit admission, re-presentation to a hospital, cardiovascular death and non-fatal cardiac arrest) including mortality. Diagnosis and complication codes are classified using the International Classification of Diseases, 10th Revision, Australian Modification (ICD-10-AM)33 and retreived from the Qld Hospital Admitted Patient Data Collection (QHAPDC).Individual charts would be reviewed for missing or ambiguous information. Records of ED presentation, complications will be retrieved through Australian New Zealand Hip fracture registry (ANZHFR), Occurrence of postoperative complication will be retrieved from the orthopaedic database from regular follow up, ANZ HFR and QH Statistical service branch (SSB) data linkage facility for readmissions from QHAPDC, ED presentations (Non-Hospital Admitted Patient Data Repository, NHAPDR), Clinic appointments for QH (public services) throughout the state and Mortality from Queensland Births Deaths and Marriages registry (QBDMR). For non-Queensland residents who were operated at TPCH during the study period, where mortality may not be recorded in the QBDMR, mortality status will initially be ascertained through the electronic records linkage to retrieve date of last episode of care within the follow-up period, including admitted, and non-admitted episodes and clinic appointments in the public health system via the QH Statistical Services Branch. In addition, their paper medical record or their Viewer record may be assessed for details such as test results or clinical notes relating to relevant outcomes of interest.
Timepoint [3] 406232 0
Day 137 to Day 273 (notional midpoint being Day 180)
Secondary outcome [4] 406233 0
Thromboembolic complications and other complications (surgical site infection (SSI), major bleeding and transfusion, pneumonia, acute renal failure, mechanical complication, readmission and reoperation, intensive care unit admission, re-presentation to a hospital, cardiovascular death and non-fatal cardiac arrest) including mortality. Diagnosis and complication codes are classified using the International Classification of Diseases, 10th Revision, Australian Modification (ICD-10-AM)33 and retreived from the Qld Hospital Admitted Patient Data Collection (QHAPDC).. Individual charts would be reviewed for missing or ambiguous information. Records of ED presentation, complications will be retrieved through Australian New Zealand Hip fracture registry (ANZHFR), Occurrence of postoperative complication will be retrieved from the orthopaedic database from regular follow up, ANZ HFR and QH Statistical service branch (SSB) data linkage facility for readmissions from QHAPDC, ED presentations (Non-Hospital Admitted Patient Data Repository, NHAPDR), Clinic appointments for QH (public services) throughout the state and Mortality from Queensland Births Deaths and Marriages registry (QBDMR). For non-Queensland residents who were operated at TPCH during the study period, where mortality may not be recorded in the QBDMR, mortality status will initially be ascertained through the electronic records linkage to retrieve date of last episode of care within the follow-up period, including admitted, and non-admitted episodes and clinic appointments in the public health system via the QH Statistical Services Branch. In addition, their paper medical record or their Viewer record may be assessed for details such as test results or clinical notes relating to relevant outcomes of interest.
Timepoint [4] 406233 0
Day 273 till until the end of 12-month time period.

Eligibility
Key inclusion criteria
Adult patients 60 years and above, who underwent surgery for hip fracture at TPCH between the years 2010-2020
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Hip fracture patients who were managed with non-surgical options
• Those with co-existing fractures in other areas

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis




Baseline characteristics will be tabulated by the BMI groups using appropriate summary statistics.
A nominal two-tailed 5% significance level will be employed. No correction for multiple testing will be performed.


BMI will be categorised into 5 groups
• <18.5
• 18.5 – 24.9
• 25 - 29.9
• 30 +
• Missing

Primary outcome analysis – Any thromboembolic complications (MI, DVT, PE, ischaemic stroke) at 90 days following hip fracture surgery.

The primary outcome will be summarised by their number and percent and will be analysed using competing risk survival analysis to take into account the competing risk of death. To allow for the adjustment of confounders between the BMI groups, Stata’s stcrreg command will be used which will give estimates of subhazard ratios.
Adjusting for imbalances in baseline characteristics will be undertaken. The variables will be included if the difference between the BMI groups are considered clinically relevant by the clinicians in the study team.

Secondary endpoint analyses
Binary secondary outcomes will be summarised by their number and percent and will be analysed using log-binomial regression to estimate risk ratios together with 95% CIs. If nonconvergence is encountered then Poisson regression will be used together with robust standard errors. Adjusting for imbalances in baseline characteristics will be undertaken using the same variables as determined for the primary outcome analysis.As we don’t have dates of events for events the date of admission will be used as a for the date of the event. For those who had an event during the admission

Missing data
Preop BMI is missing in 1,612/3,362 (48%) of the data (height and weight missing 48%). The majority of this missing data was for the years to 2014. For 2015 to 2020 eligible participants there were no missing BMI data and only these would be included in the BMI analysis

Sample size justification:
Initially a sample size calculaton was undertaken and data was made available for the years 2010-2020, however the years 2010-2014 had 1,411/1,456 (97%) missing BMI data, hence only the years 2015-2020 were included in the analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/02/2022
Actual
1/01/2015
Date of last participant enrolment
Anticipated
31/12/2024
Actual
31/12/2020
Date of last data collection
Anticipated
31/12/2024
Actual
31/12/2020
Sample size
Target
2500
Accrual to date
Final
1853
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21702 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 36754 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 310762 0
Government body
Name [1] 310762 0
Queensland Advancing Clinical Research Fellowship
Country [1] 310762 0
Australia
Primary sponsor type
Individual
Name
Usha Gurunathan
Address
Department of Anaesthesia, The Prince Charles Hospital, Rode Road, Chermside, Queensland 4032
Country
Australia
Secondary sponsor category [1] 311996 0
None
Name [1] 311996 0
Address [1] 311996 0
Country [1] 311996 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310338 0
The Prince Charles Hospital Human Resarch Ethics Committee
Ethics committee address [1] 310338 0
Ethics committee country [1] 310338 0
Australia
Date submitted for ethics approval [1] 310338 0
Approval date [1] 310338 0
14/10/2020
Ethics approval number [1] 310338 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117290 0
Dr Usha Gurunathan
Address 117290 0
Department of Anaesthesia, The Prince Charles Hospital, Rode road, Chermside, Queensland, 4032
Country 117290 0
Australia
Phone 117290 0
+61 7 3139 4995
Fax 117290 0
Email 117290 0
[email protected]
Contact person for public queries
Name 117291 0
Usha Gurunathan
Address 117291 0
Department of Anaesthesia, The Prince Charles Hospital, Rode road, Chermside, Queensland, 4032
Country 117291 0
Australia
Phone 117291 0
+61 7 3139 4995
Fax 117291 0
Email 117291 0
[email protected]
Contact person for scientific queries
Name 117292 0
Usha Gurunathan
Address 117292 0
Department of Anaesthesia, The Prince Charles Hospital, Rode road, Chermside, Queensland, 4032
Country 117292 0
Australia
Phone 117292 0
+61 7 3139 4995
Fax 117292 0
Email 117292 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This is a retrospective study and individual participant data may not be useful. However, data sharing is undecided at the moment and will be at the discretion of the principal investigator



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.