Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000177752
Ethics application status
Approved
Date submitted
8/02/2013
Date registered
13/02/2013
Date last updated
13/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Non-surgical outcomes among older adults after total joint replacement.
Scientific title
Neuropsychological and affective outcomes among older adults after total joint replacement.
Secondary ID [1] 281929 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post operative cognitive dysfunction 288331 0
depression 288332 0
anxiety 288333 0
Condition category
Condition code
Neurological 288681 288681 0 0
Other neurological disorders
Mental Health 288682 288682 0 0
Depression
Mental Health 288683 288683 0 0
Anxiety

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants are older adults who are undergoing standard care total hip and knee replacement. They will be assessed on three occasions: approx 2 weeks pre-surgery, 2 weeks post-surgery, 6 months post-surgery. They will be assessed on their cognitive function(baseline and 2nd follow-up only), depression, anxiety, quality of life, pain and cognitive reserve (baseline only).
Intervention code [1] 286490 0
Not applicable
Comparator / control treatment
Patient scores will be compared with those of healthy controls at all follow-up assessments. Healthy controls will consist of spouses, close friends or siblings of the patients, so will be similar with regard to age, SES and education. They cannot have undergone invasive surgery within the previous 6 months, or during the current study. They will be assessed along the same time frame as the patients.
Control group
Active

Outcomes
Primary outcome [1] 288832 0
Cognitive dysfunction: determined through a significant decline in performance on a battery of neuropsychological tests. This decline has to be independent from any time-related confounds, and will be determined through standardised regression-based methodology.
% of patients with cognitive dysfunction
Timepoint [1] 288832 0
6 months post-surgery.
Primary outcome [2] 288833 0
Depression: Hospital Depression and Anxiety Scale - score > 7 = mild depression, > 11 = moderate depression, > 16 = severe depression.
% of patients with depression.
Timepoint [2] 288833 0
baseline, 2 weeks post-surgery, 6 months post-surgery.
Primary outcome [3] 288834 0
Anxiety: Hospital Depression and Anxiety Scale - score > 7 = mild anxiety, > 11 = moderate anxiety, > 16 = severe anxiety.
% of patients with anxiety.
Timepoint [3] 288834 0
baseline, 2 week post-surgery, 6 month post-surgery
Secondary outcome [1] 301086 0
Pain, as indicated by the patient on a scale of 0 (no pain) to 100 (worst pain imaginable)
Timepoint [1] 301086 0
baseline, 2 weeks post-surgery, 6 months post-surgery
Secondary outcome [2] 301087 0
Quality of Life: Scores on the SF-36 v2
Timepoint [2] 301087 0
baseline, 2 weeks post-surgery, 6 months post-surgery

Eligibility
Key inclusion criteria
Joint replacement patients
- Undergoing primary total hip or knee replacement
- Aged 50 or over
- Proficient in English
Controls
- Are a partner, close friend or sibling of one undergoing primary total hip or knee replacement (who passes the relevant inclusion/exclusion criteria
- Aged 50 or over
- Proficient in English
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
Joint replacement patients:
- Undergoing revision surgery, partial replacement or any other type of joint surgery.
- Have an existing neurological condition (e.g. dementia, multiple sclerosis), that is likely to affect performance on a cognitive battery
Controls:
- Have had invasive surgery (minimally invasive is acceptable) within the previous 6 months or have surgery planned for the following six months
- Have an existing neurological condition that is likely to affect performance on a cognitive battery

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/08/2012
Actual
31/01/2013
Date of last participant enrolment
Anticipated
31/07/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 562 0
Repatriation Hospital - Daw Park
Recruitment postcode(s) [1] 6302 0
5041 - Daw Park

Funding & Sponsors
Funding source category [1] 286714 0
Government body
Name [1] 286714 0
Funded in part by an Australian Postgraduate Award,
The Department of Industry, Innovation, Science, Research and Tertiary Education
Country [1] 286714 0
Australia
Primary sponsor type
Individual
Name
Prof Jane L. Mathias
Address
Rm 524, Hughes Building
School of Psychology,
North Tce Campus
University of Adelaide
Adelaide,
SA, 5005
Country
Australia
Secondary sponsor category [1] 285486 0
Individual
Name [1] 285486 0
Ms Julia Scott
Address [1] 285486 0
Rm 217, Hughes Building
School of Psychology,
North Tce Campus
University of Adelaide
Adelaide,
SA, 5005
Country [1] 285486 0
Australia
Secondary sponsor category [2] 285487 0
Individual
Name [2] 285487 0
Dr Anthony C. Kneebone
Address [2] 285487 0
Department of Clinical Psychology
Flinders Medical Centre
Bedford Park SA 5042
Country [2] 285487 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288780 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 288780 0
Flinders Medical Centre
The Flats, G5, Rms 3 and 4
Flinders Drive,
Bedford Pk,
SA 5042
Ethics committee country [1] 288780 0
Australia
Date submitted for ethics approval [1] 288780 0
04/09/2012
Approval date [1] 288780 0
10/07/2012
Ethics approval number [1] 288780 0
057.12
Ethics committee name [2] 288781 0
Human Research Ethics Committee - University of Adelaide
Ethics committee address [2] 288781 0
University of Adelaide
SA, 5005
Ethics committee country [2] 288781 0
Australia
Date submitted for ethics approval [2] 288781 0
11/05/2012
Approval date [2] 288781 0
11/07/2012
Ethics approval number [2] 288781 0
H-2012-072

Summary
Brief summary
This study aims to examine the incidence of cognitive and affective problems after joint replacement surgery. These outcomes will also be placed into context of post-surgical pain and quality of life. The potential moderating role of cognitive reserve will also be assessed.
The specific aims of the study are to:
a) Define the incidence of short- and long-term cognitive dysfunction, depression and anxiety following joint replacement surgery.
b) Determine the potential moderating role of reserve on these poorer outcomes.
c) Identify the predictors of these poorer outcomes, with specific reference to quality of life, pain, and chronic medical conditions
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37742 0
Prof Jane L. Mathias
Address 37742 0
Rm 524, Hughes Building
School of Psychology,
University of Adelaide
North Terrace Campus
SA, 5005
Country 37742 0
Australia
Phone 37742 0
+61 8 8303 5266
Fax 37742 0
Email 37742 0
[email protected]
Contact person for public queries
Name 37743 0
Jane L. Mathias
Address 37743 0
Rm 524, Hughes Building
School of Psychology,
University of Adelaide
North Terrace Campus
SA, 5005
Country 37743 0
Australia
Phone 37743 0
+61 8 8303 5266
Fax 37743 0
Email 37743 0
[email protected]
Contact person for scientific queries
Name 37744 0
Jane L. Mathias
Address 37744 0
Rm 524, Hughes Building
School of Psychology,
University of Adelaide
North Terrace Campus
SA, 5005
Country 37744 0
Australia
Phone 37744 0
+61 8 8303 5266
Fax 37744 0
Email 37744 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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