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Trial registered on ANZCTR


Registration number
ACTRN12618000334202
Ethics application status
Approved
Date submitted
23/02/2018
Date registered
6/03/2018
Date last updated
6/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Are falls associated with psychological issues in patients undergoing orthopaedic total knee or hip replacement surgery?
Scientific title
Are falls and falls risk associated with pain catastrophising, anxiety and depression in patients undergoing orthopaedic total knee or hip replacement surgery?
Secondary ID [1] 294140 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
NIl

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 306765 0
knee replacement 306766 0
hip replacement 306767 0
falls 306768 0
anxiety 306769 0
depression 306797 0
Condition category
Condition code
Mental Health 305863 305863 0 0
Anxiety
Surgery 305903 305903 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of the study is to determine whether falls, pain catastrophising, anxiety and depression are associated with poorer post-operative outcomes including falls risk, We will be studying the number of falls, physical function, functional mobility, length of stay, and the need for extra rehabilitation services in patients undergoing total knee and hip joint replacement.
Key research questions are:
Does falls risk, anxiety and depression preoperatively predict post operative
poor outcomes following total knee and hip replacement surgery?
Do psychological and physical components have an association in the prediction of falls in the preoperative and post operative periods in the patients having total knee and hip joint replacement?
Method:
Patients will be assessed preoperatively and fill out questionnaires that relate to function, mental well being and also participate in a physical assessment test that includes a physiological profile score for falls and timed up and go tests.
When patients are admitted for the surgery, any falls in the hospital is recorded, length of hospital stay and discharge destination and additional services requirements on discharge also noted.
At 6 weeks post operatively all the questionnaires and the physical assessment are repeated.
Intervention code [1] 300432 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304942 0
falls
Measured from hospital records and also patient reported.
Timepoint [1] 304942 0
preoperatively at 4-6 weeks when they attend preadmission clinic( primary start point)
at the time of admission and on discharge from the hospital
6 weeks post operatively( primary end point)
Primary outcome [2] 304943 0
anxiety and depression
Questionnaires used (Hospital Anxiety and Depression Scale)
Timepoint [2] 304943 0
preoperatively 4-6 weeks prior to the surgery
6 weeks post operatively
Primary outcome [3] 304944 0
pain catastrophising
PCS ( pain catastrophising score ) questionnaire used
Timepoint [3] 304944 0
preoperatively 4-6 weeks prior to the surgery
6wks post operatively
Secondary outcome [1] 343583 0
length of hospital stay
Using Hospital records
Timepoint [1] 343583 0
on admission for surgery and discharge from surgery

Eligibility
Key inclusion criteria
patients who are having total knee replacement or total hip replacement surgery
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients unable to fill forms in English

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

Descriptive statistics will be used to describe the population study. To compare the characteristics of the sample before and after surgery a range of tests will be performed according to the distribution of the variable of interest. This will include chi-square for categorical variables, parametric tests for normally distributed continuous variables (e.g. t-tests, paired t-tests) and non-parametric tests for non-normally distributed continuous variables (e.g. Mann-whitney tests, and Wilcoxon rank sign tests). Univariate and multiple regression analysis will be used to analyse associations between falls risk and other physiological measures with psychological characteristics (predictors). Significance will be set at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/03/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10120 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 21654 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 298776 0
Hospital
Name [1] 298776 0
Concord Repatriation Hospital
Country [1] 298776 0
Australia
Primary sponsor type
Hospital
Name
Concord Repatriation Hospital
Address
Hospital Rd
Concord2139
NSW
Country
Australia
Secondary sponsor category [1] 297960 0
None
Name [1] 297960 0
Address [1] 297960 0
Country [1] 297960 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299723 0
Human Research ethics commitee Concord Repatriation Hospital
Ethics committee address [1] 299723 0
Ethics committee country [1] 299723 0
Australia
Date submitted for ethics approval [1] 299723 0
03/05/2017
Approval date [1] 299723 0
08/11/2017
Ethics approval number [1] 299723 0

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

Contacts
Principal investigator
Name 81374 0
Mrs Sathiyapriya Gnanakumaran
Address 81374 0
Sydney Local Health District
Concord Repatriation Hospital
Hospital Rd
Concord 2139 NSW Australia
Country 81374 0
Australia
Phone 81374 0
+61421546752
Fax 81374 0
Email 81374 0
priya.gnanakumaran@health.nsw.gov.au
Contact person for public queries
Name 81375 0
Sathiyapriya Gnanakumaran
Address 81375 0
Sydney Local Health District
Concord Repatriation Hospital
Hospital Rd
Concord 2139 NSW Australia
Country 81375 0
Australia
Phone 81375 0
+61421546752
Fax 81375 0
Email 81375 0
priya.gnanakumaran@health.nsw.gov.au
Contact person for scientific queries
Name 81376 0
Sathiyapriya Gnanakumaran
Address 81376 0
Sydney Local Health District
Concord Repatriation Hospital
Hospital Rd
Concord 2139 NSW Australia
Country 81376 0
Australia
Phone 81376 0
+61421546752
Fax 81376 0
Email 81376 0
priya.gnanakumaran@health.nsw.gov.au

No information has been provided regarding IPD availability


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.