Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000459123
Ethics application status
Approved
Date submitted
11/03/2019
Date registered
20/03/2019
Date last updated
20/03/2019
Date data sharing statement initially provided
20/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of association of central sensitization with postoperative outcomes in patients with total knee replacements
Scientific title
Investigation of association of central sensitization with postoperative outcomes in patients with total knee replacements
Secondary ID [1] 297688 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 311969 0
total knee replacement 311970 0
Condition category
Condition code
Musculoskeletal 310543 310543 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Aims: To determine whether an individual’s response to pain, as measured by preoperative questionnaires examining pain hypervigilance and central sensitization, can accurately predict poor postoperative total knee replacement outcomes.

Patients will complete surveys at their routine pre-operative clinic appointment 1-2 months prior to surgery, and routine post-operative appointments at the 3 week, 6 week and 12 month mark post-operatively. Pre-operatively, they will complete the PVAQ (pain hypervigilance and awareness questionnaire), CSI (central sensitisation inventory), KOOS (knee osteoarthritis outcome score), OKS (oxford knee score) and FJS (forgotten joint score). Post-operatively they will complete the CSI (central sensitisation inventory), KOOS (knee osteoarthritis outcome score), OKS (oxford knee score) and FJS (forgotten joint score). Patients will complete surveys up to 12 months post-operatively (at 3 weeks, 6 weeks and 12 months).
Intervention code [1] 313920 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319408 0
Functional outcome as assessed by the KOOS score
Timepoint [1] 319408 0
Preoperative questionnaire: 1-2 months prior to operation
Postoperative questionnaires: 3 weeks, 6 weeks and 12 month post surgery
Secondary outcome [1] 368039 0
Functional outcome as assessed by the Oxford Knee Score
Timepoint [1] 368039 0
Postoperative questionnaires: 3 weeks, 6 weeks and 12 month post surgery
Secondary outcome [2] 368412 0
Functional outcome as assessed by the Forgotten Joint Score
Timepoint [2] 368412 0
Postoperative questionnaires: 3 weeks, 6 weeks and 12 month post surgery
Secondary outcome [3] 368413 0
Central Sensitisation Inventory Score
Timepoint [3] 368413 0
Pre-operative (1-2 months prior to surgery)
Secondary outcome [4] 368414 0
Pain Hyper-vigilance and Awareness Questionnaire Score
Timepoint [4] 368414 0
Pre-operative (1-2 months prior to surgery)

Eligibility
Key inclusion criteria
All adults (18+) undergoing elective Total Knee Replacement (TKR) for osteoarthritis of the knee.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who wish to be excluded from the study or cannot participate due to issues with understanding, either due to language barriers or otherwise, such as intellectual disability. These individuals will be excluded from the study as this study relies upon data gathered through validated questionnaires that are self-administered after informed consent is obtained, with numerous questionnaires (CSI, FJS-12) not having validated versions available in numerous other languages. The internal validity of the study is difficult to maintain if individuals who are unable to understand the questionnaires presented are included in our patient cohort.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Continuous variables will be summarized as medians and interquartile ranges and categorical variables as counts and proportions respectively. The associations between the CSI and PVAQ scores with the KOOS, OKS and FJS scores will be investigated using the Spearman correlation co-efficient and further explored using either linear or quantile regression depending on the distributions of the outcomes. This analysis will include the postoperative change in pain and function over time. An exploratory analysis of individual associations between individual items from the CSI and PVAQ scores with the KOOS, OKS and FJS scores will be conducted using appropriate regression models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2019
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)
VIC

Funding & Sponsors
Funding source category [1] 302213 0
Self funded/Unfunded
Name [1] 302213 0
Michael Wang
Country [1] 302213 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Wang
Address
Austin Health, 145 Studley Road, Heidelberg 3084 VIC
Country
Australia
Secondary sponsor category [1] 302063 0
None
Name [1] 302063 0
Address [1] 302063 0
Country [1] 302063 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302893 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 302893 0
Ethics committee country [1] 302893 0
Australia
Date submitted for ethics approval [1] 302893 0
01/04/2018
Approval date [1] 302893 0
28/09/2018
Ethics approval number [1] 302893 0
HREC/18/Austin/143

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

Contacts
Principal investigator
Name 91758 0
Dr Michael Wang
Address 91758 0
Austin Health, 145 Studley Road, Heidelberg 3084, Victoria, Australia
Country 91758 0
Australia
Phone 91758 0
+6 3 9496 5000
Fax 91758 0
Email 91758 0
[email protected]
Contact person for public queries
Name 91759 0
Michael Wang
Address 91759 0
Austin Health, 145 Studley Road, Heidelberg 3084, Victoria, Australia
Country 91759 0
Australia
Phone 91759 0
+6 3 9496 5000
Fax 91759 0
Email 91759 0
[email protected]
Contact person for scientific queries
Name 91760 0
Michael Wang
Address 91760 0
Austin Health, 145 Studley Road, Heidelberg 3084, Victoria, Australia
Country 91760 0
Australia
Phone 91760 0
+61394965000
Fax 91760 0
Email 91760 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


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.