Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000653561
Ethics application status
Approved
Date submitted
5/06/2015
Date registered
24/06/2015
Date last updated
10/11/2020
Date data sharing statement initially provided
10/11/2020
Date results information initially provided
10/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Rates and cost of falls after total hip and total knee replacement surgery - an observational cohort study
Scientific title
Incidence, risk factors and the healthcare cost of falls post discharge after elective total hip and total knee replacement surgery: A prospective observational cohort study of patients recruited from a large Western Australian private tertiary hospital
Secondary ID [1] 286861 0
Nil
Universal Trial Number (UTN)
U1111-1170-9877
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total hip arthroplasty 295256 0
Total Knee Arthroplasty 295257 0
Falls 295372 0
Condition category
Condition code
Musculoskeletal 295502 295502 0 0
Other muscular and skeletal disorders
Surgery 295503 295503 0 0
Other surgery
Injuries and Accidents 295637 295637 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Months
Description of intervention(s) / exposure
Elective total hip or total knee arthroplasties, observed for 12 months after the operation
Intervention code [1] 292032 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295240 0
rate of falls assessed with a diary provided to participants and monthly phone calls after discharge
Timepoint [1] 295240 0
12 months after surgery
Secondary outcome [1] 315165 0
proportion of patients who fall assessed with a diary provided to participants and monthly phone calls after discharge
Timepoint [1] 315165 0
12 months after surgery
Secondary outcome [2] 315166 0
rates of injurious falls assessed with a diary provided to participants and monthly phone calls after discharge
Timepoint [2] 315166 0
12 months after surgery
Secondary outcome [3] 315167 0
health-related quality of life assessed using EQ-5D-5L scale
Timepoint [3] 315167 0
1 month, 6months and 12 months after surgery

Eligibility
Key inclusion criteria
admitted for elective major hip or knee arthroplasty; recruited no later than one week after discharge from hospital; able to give informed consent or family able to give consent; discharge to community.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
emergency total hip replacement following fractured neck of femur;
not able to read or understand English
discharged to residential aged care facility

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The primary outcome measure (rates of falls) will be expressed using an incident rate per 1000 days. The secondary outcome measure of rate of injurious falls will be expressed using an incident rate per 1000 days, while the number of fallers will be expressed as a percentage. Generalised linear mixed modelling will be used to examine the falls outcomes (falls and injurious falls rates and the proportion of patients who fell) in the 12 months after discharge in comparison to falls outcomes observed among a broad post discharge population. Generalized linear mixed modelling will also be conducted to examine patient and clinical characteristics predictive of falls in the 12 months after discharge. The health-related quality of life of patients over the first 12-months following discharge from hospital will be described using conventional descriptive statistics, then examined for fallers and non-fallers using adjusted and unadjusted generalized liner mixed modelling.

On the basis of a previous study conducted in a large and broad diagnostic post discharge population the annual incidence rate for falls after hospital discharge in an elderly population was reported to be 4.5/1000 person days. The minimum sample size needed to test the hypothesis that the population incidence rate for falls (in patients who have undergone TKR or THR) is 4.5/1000 person days (+0.54/1000) at 5% level of significance (with 95% confidence to detect this) and power of 80% is 267 participants in the total hip replacement group and 267 participants in the total knee replacement groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/06/2015
Actual
26/06/2015
Date of last participant enrolment
Anticipated
30/12/2016
Actual
3/03/2017
Date of last data collection
Anticipated
1/05/2018
Actual
20/05/2018
Sample size
Target
434
Accrual to date
Final
434
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3887 0
St John of God Hospital, Murdoch - Murdoch

Funding & Sponsors
Funding source category [1] 291418 0
University
Name [1] 291418 0
The University of Notre Dame Australia
Country [1] 291418 0
Australia
Primary sponsor type
University
Name
The University of Notre Dame Australia
Address
PO Box 1225 19 Mouat St
Fremantle WA 6959
Country
Australia
Secondary sponsor category [1] 290095 0
Hospital
Name [1] 290095 0
St John of God Hospital Murdoch
Address [1] 290095 0
100 Murdoch Drive
Murdoch WA 6150
Country [1] 290095 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292970 0
The University of Notre Dame Australia HREC
Ethics committee address [1] 292970 0
PO Box 1225 19 Mouat St
Fremantle WA 6959
Ethics committee country [1] 292970 0
Australia
Date submitted for ethics approval [1] 292970 0
Approval date [1] 292970 0
17/03/2015
Ethics approval number [1] 292970 0
015027F
Ethics committee name [2] 292971 0
St John of God Hospital Murdoch HREC
Ethics committee address [2] 292971 0
100 Murdoch Drive
Murdoch WA 6150
Ethics committee country [2] 292971 0
Australia
Date submitted for ethics approval [2] 292971 0
Approval date [2] 292971 0
11/02/2015
Ethics approval number [2] 292971 0
760

Summary
Brief summary
Older people in Australia are increasingly undergoing hip and knee joint replacement , and with aging of the population this figure will increase. Although outcomes are positive after this surgery there are limited data that have investigated the incidence of falls after this surgery. Falls are associated with injury and loss of function as well as psychological consequences which could lead to reduced health related quality of life. This study will prospectively sample over 500 older people to measure the incidence of falls in the 12 months after discharge. The aim of the study is to identify the number of falls and risk factors for falling as well as patient health related quality of life among older people in the 12 months after they have hip or knee joint replacements.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57834 0
Prof Anne-Marie Hill
Address 57834 0
School of Physiotherapy and Exercise Science,
Curtin University Kent St, Bentley WA Australia, 6102
GPO BOX U1987, Perth WA 6845
Country 57834 0
Australia
Phone 57834 0
+61892664104
Fax 57834 0
Email 57834 0
[email protected]
Contact person for public queries
Name 57835 0
Prof Anne-Marie Hill
Address 57835 0
School of Physiotherapy and Exercise Science,
Curtin University Kent St, Bentley WA Australia, 6102
GPO BOX U1987, Perth WA 6845
Country 57835 0
Australia
Phone 57835 0
+61892664104
Fax 57835 0
Email 57835 0
[email protected]
Contact person for scientific queries
Name 57836 0
Prof Anne-Marie Hill
Address 57836 0
School of Physiotherapy and Exercise Science,
Curtin University Kent St, Bentley WA Australia, 6102
GPO BOX U1987, Perth WA 6845
Country 57836 0
Australia
Phone 57836 0
+61892664104
Fax 57836 0
Email 57836 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
not included in participant ethics forms at point of trial design


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9692Study protocolHill, A. M., Ross-Adjie, G., McPhail, S. M., Monterosso, L., Bulsara, M., Etherton-Beer, C., . . . Hardisty, G. (2016). Incidence, risk factors and the healthcare cost of falls postdischarge after elective total hip and total knee replacement surgery: protocol for a prospective observational cohort study. BMJ Open, 6(7), e011139. doi:10.1136/bmjopen-2016-011139https://bmjopen.bmj.com/content/6/7/e011139.citation-tools[email protected] nil other



Results publications and other study-related documents

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

Documents added automatically
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