ANZCTR - Registration

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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

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]

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

Total Knee Arthroplasty

Falls

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Surgery

Other surgery

Injuries and Accidents

Other injuries and accidents

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Not applicable

Comparator / control treatment

N/A

Control group

Uncontrolled

Outcomes

Primary outcome [1]

rate of falls assessed with a diary provided to participants and monthly phone calls after discharge

Timepoint [1]

12 months after surgery

Secondary outcome [1]

proportion of patients who fall assessed with a diary provided to participants and monthly phone calls after discharge

Timepoint [1]

12 months after surgery

Secondary outcome [2]

rates of injurious falls assessed with a diary provided to participants and monthly phone calls after discharge

Timepoint [2]

12 months after surgery

Secondary outcome [3]

health-related quality of life assessed using EQ-5D-5L scale

Timepoint [3]

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?

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)

Recruitment hospital [1]

St John of God Hospital, Murdoch - Murdoch

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Notre Dame Australia

Address [1]

The University of Notre Dame Australia
PO Box 1225 19 Mouat St
Fremantle WA 6959

Country [1]

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]

Hospital

Name [1]

St John of God Hospital Murdoch

Address [1]

100 Murdoch Drive
Murdoch WA 6150

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Notre Dame Australia HREC

Ethics committee address [1]

PO Box 1225 19 Mouat St
Fremantle WA 6959

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

17/03/2015

Ethics approval number [1]

015027F

Ethics committee name [2]

St John of God Hospital Murdoch HREC

Ethics committee address [2]

100 Murdoch Drive
Murdoch WA 6150

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

11/02/2015

Ethics approval number [2]

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

Prof Anne-Marie Hill

Address

School of Physiotherapy and Exercise Science,
Curtin University Kent St, Bentley WA Australia, 6102
GPO BOX U1987, Perth WA 6845

Country

Australia

Phone

+61892664104

Fax

[email protected]

Contact person for public queries

Name

Anne-Marie Hill

Address

School of Physiotherapy and Exercise Science,
Curtin University Kent St, Bentley WA Australia, 6102
GPO BOX U1987, Perth WA 6845

Country

Australia

Phone

+61892664104

Fax

[email protected]

Contact person for scientific queries

Name

Anne-Marie Hill

Address

School of Physiotherapy and Exercise Science,
Curtin University Kent St, Bentley WA Australia, 6102
GPO BOX U1987, Perth WA 6845

Country

Australia

Phone

+61892664104

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
9692	Study protocol	Hill, 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-2016-011139	https://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

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically