Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000446167
Ethics application status
Approved
Date submitted
6/03/2019
Date registered
19/03/2019
Date last updated
19/03/2019
Date data sharing statement initially provided
19/03/2019
Date results information initially provided
19/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Opioid use after hip and knee replacement
Scientific title
Persistent Opioid Use after Hip and Knee Arthroplasty: A Retrospective cohort study
Secondary ID [1] 297590 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
opioid use after joint replacement 311848 0
Condition category
Condition code
Surgery 310446 310446 0 0
Other surgery
Anaesthesiology 310621 310621 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Consecutive patients who underwent unilateral primary total hip replacement or total knee replacement were invited to participate in the survey 3 months post-surgery. This survey was designed by a panel of experienced clinicians (an anaesthetist, 2 surgeons, a nurse and a physiotherapist) and consisted of 10 multiple-choice questions, and 1 free text response. The survey was sent via email or post 3 months post operatively. Patients were provided a reference list of common opioids to help identify their opioid medications
Intervention code [1] 313825 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319313 0
Opioid use post surgery- assessed from survey designed specifically for this study
Timepoint [1] 319313 0
3 months post surgery
Secondary outcome [1] 367718 0
Risk factors for opioid use- assessed from survey designed specifically for this study.
Timepoint [1] 367718 0
3 months post surgery

Eligibility
Key inclusion criteria

• Age greater than 18 at the time of surgery
• Unilateral THA or TKA surgery
• The individual is capable of understanding the questionnaire and responding in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Revision or bilateral joint replacement
• Significant pain-related illness within 3 months following surgery
• Further surgical procedures in the 3 months after joint replacement that requires prescription opioids

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The study will aim to enrol 100 TKA or THA patients at 3 months following their operation date anniversary. This sample we consider large enough to estimate the extent of the problem in our institution.

This is based of similar studies at other institutions

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2017
Date of last participant enrolment
Anticipated
Actual
31/10/2017
Date of last data collection
Anticipated
Actual
31/01/2018
Sample size
Target
100
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 13292 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 25866 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 302140 0
Other
Name [1] 302140 0
The Joint Studio
Country [1] 302140 0
Australia
Primary sponsor type
Other
Name
The Joint Studio
Address
Suite 1/85 Monash Avenue, Nedland, WA 6009
Country
Australia
Secondary sponsor category [1] 302119 0
Hospital
Name [1] 302119 0
Hollywood Private Hospital
Address [1] 302119 0
Monash Ave, Nedlands WA 6009
Country [1] 302119 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302819 0
Hollywood Private Hospital Research Ethics Committee
Ethics committee address [1] 302819 0
Hollywood Private Hospital
Monash Avenue, Nedlands, WA, 6009.
Ethics committee country [1] 302819 0
Australia
Date submitted for ethics approval [1] 302819 0
Approval date [1] 302819 0
14/07/2017
Ethics approval number [1] 302819 0
HPH 499

Summary
Brief summary
Opioids are an important tool in the management of pain and the benefits are well understood. However, opioids for some patients, may also have a detrimental influence on how much benefit you get from your joint replacement surgery. This is the subject of ongoing research. In this study we would like to gain a better understanding on the taking of opioid medications both before and after joint replacement surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91502 0
Dr Praveen Vasantharao
Address 91502 0
The Joint Studio,
Suite 1/85 Monash Avenue, Nedlands, WA 6009
Country 91502 0
Australia
Phone 91502 0
+61 93863933
Fax 91502 0
Email 91502 0
[email protected]
Contact person for public queries
Name 91503 0
Dr Praveen Vasantharao
Address 91503 0
The Joint Studio,
Suite 1/85 Monash Avenue, Nedlands, WA 6009
Country 91503 0
Australia
Phone 91503 0
+61 93863933
Fax 91503 0
Email 91503 0
[email protected]
Contact person for scientific queries
Name 91504 0
Dr Praveen Vasantharao
Address 91504 0
The Joint Studio,
Suite 1/85 Monash Avenue, Nedlands, WA 6009
Country 91504 0
Australia
Phone 91504 0
+61 93863933
Fax 91504 0
Email 91504 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
patient privacy concerns


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.