Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000369628
Ethics application status
Approved
Date submitted
27/03/2014
Date registered
7/04/2014
Date last updated
15/10/2021
Date data sharing statement initially provided
15/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Joint pain without a joint? An investigation into the nature of postsurgical pain following joint replacement
Scientific title
Evaluating the presence and nature of postsurgical pain in people undergoing total knee replacements - an observational study
Secondary ID [1] 284171 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 291266 0
total knee arthroplasty 291267 0
postsurgical joint pain 291573 0
Condition category
Condition code
Musculoskeletal 291620 291620 0 0
Osteoarthritis
Neurological 291629 291629 0 0
Other neurological disorders
Surgery 291952 291952 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
This observational study aims to evaluate an inception cohort of participants that are about to undergo total knee arthroplasty due to osteoathritis. Participants will be assessed prior to surgery and then followed one year post-surgery.
Intervention code [1] 288870 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291556 0
Presence of persistent joint pain (pain in the joint that has been present for at least 3 months); assessed by the question: "Have you had pain in the area of your replaced knee joint and has this pain been present for the last 3 months?"
Timepoint [1] 291556 0
3, 6, and 12 months
Secondary outcome [1] 307071 0
Presence of cortical pain components assessed via Implicit motor imagery performance (left/right judgements; accuracy and speed)
Timepoint [1] 307071 0
Baseline and 6 months
Secondary outcome [2] 307480 0
Presence of cortical pain components assessed via two point discrimination thresholds (TPD).
Timepoint [2] 307480 0
Baseline and 6 months
Secondary outcome [3] 307481 0
Presence of cortical pain components assessed via judgements of perceived knee size.
Timepoint [3] 307481 0
Baseline and 6 months
Secondary outcome [4] 307482 0
Presence of cortical pain components assessed via the visual and motor imagery scale.
Timepoint [4] 307482 0
Baseline, 1, 3, 6, and 12 months
Secondary outcome [5] 307483 0
Presence of cortical pain components assessed via the neglect scale.
Timepoint [5] 307483 0
Baseline, 1, 3, 6, and 12 months
Secondary outcome [6] 307484 0
Presence of cortical pain components assessed via body drawings.
Timepoint [6] 307484 0
Baseline, 1, 3, 6, and 12 months
Secondary outcome [7] 307485 0
Presence of neuropathic components of pain assessed via thermal sensory thresholds (innocous heat and cold stimuli).
Timepoint [7] 307485 0
Baseline and 6 months
Secondary outcome [8] 307486 0
Presence of neuropathic components of pain assessed via thermal pain thresholds (noxious heat and cold stimuli).
Timepoint [8] 307486 0
Baseline and 6 months
Secondary outcome [9] 307487 0
Presence of neuropathic components of pain assessed via dynamic tactile allodynia.
Timepoint [9] 307487 0
Baseline and 6 months
Secondary outcome [10] 307488 0
Presence of neuropathic components of pain assessed via pressure pain thresholds (noxious mechanical stimulus).
Timepoint [10] 307488 0
Baseline and 6 months
Secondary outcome [11] 307489 0
Presence of neuropathic components of pain assessed via hyperalgesia to pinprick.
Timepoint [11] 307489 0
Baseline and 6 months
Secondary outcome [12] 307490 0
Presence of neuropathic components of pain assessed via the painDETECT Questionnaire.
Timepoint [12] 307490 0
Baseline, 1, 3, 6, and 12 months
Secondary outcome [13] 307491 0
Presence of neuropathic components of pain assessed via the self-assessed version of the Leeds Assessment of Neuropathic Symptoms (S-LANSS) questionnaire.
Timepoint [13] 307491 0
Baseline, 1, 3, 6, and 12 months
Secondary outcome [14] 307538 0
Knee pain intensity, assessed using a 0-100 numerical rating scale (NRS)
Timepoint [14] 307538 0
Baseline, 1, 3, 6, and 12 months

Eligibility
Key inclusion criteria
Patient attending Wakefield Orthopaedic Clinic or The Queen Elizabeth Hospital to undergo a total knee replacement surgery for osteoarthritis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients undergoing a revision surgery for Osteoarthritis.
Patients undergoing joint replacement for Rheumatoid Arthritis.
Patients who have had an athroscopy (in the last 6 months) of the joint that will be replaced.
Patients with a neurological disorder affecting the lower limb (ie, stroke/traumatic brain injury that results
in reduced lower limb function; multiple sclerosis; peripheral nerve injury affecting the lower limb).
Patients who have an inability to communicate or understand the English language (project funding for
interpreter services is not available).
Patients with difficulties in general communication and understanding (ie, dementia, Alzheimer’s).

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The rate of post-surgical pain following knee joint replacement surgery is estimated to range between 7-20%. One hundred participants will be recruited for this pilot study as 7-20 events will allow for assessment of the univariate relationships between baseline predictors and presence of post-surgical pain (eg, it is recommended that 10 'events' are needed for every predictor in the analysis). Univariate logistic regression (pain/no pain) and linear regression (intensity of pain) will be used to determine the relationship between a priori chosen variables and the presence of pain post-arthroplasty.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/04/2014
Actual
24/07/2014
Date of last participant enrolment
Anticipated
Actual
7/08/2017
Date of last data collection
Anticipated
Actual
7/08/2018
Sample size
Target
100
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2251 0
Wakefield Orthopaedic Clinic - Adelaide
Recruitment hospital [2] 20748 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 7830 0
5000 - Adelaide
Recruitment postcode(s) [2] 35559 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 288802 0
Charities/Societies/Foundations
Name [1] 288802 0
The Zimmer Australia Grant funded by Zimmer Australia and administered by Arthritis Australia
Country [1] 288802 0
Australia
Primary sponsor type
Individual
Name
Tasha Stanton
Address
The University of South Australia
School of Health Sciences
GPO Box 2471
Adelaide, South Australia
5001
Country
Australia
Secondary sponsor category [1] 287498 0
None
Name [1] 287498 0
Address [1] 287498 0
Country [1] 287498 0
Other collaborator category [1] 277847 0
Individual
Name [1] 277847 0
G. Lorimer Moseley
Address [1] 277847 0
The University of South Australia
School of Health Sciences
GPO Box 2471
Adelaide, South Australia
5001
Country [1] 277847 0
Australia
Other collaborator category [2] 277848 0
Individual
Name [2] 277848 0
Chris Schutz
Address [2] 277848 0
Wakefield Orthopaedic Clinic
Clinical Research Coordinator
2nd Floor, 270 Wakefield St,
Adelaide, South Australia
5000
Country [2] 277848 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290647 0
Calvary Health Care Adelaide (CHCA) Human Research Ethics Committee
Ethics committee address [1] 290647 0
Ethics committee country [1] 290647 0
Australia
Date submitted for ethics approval [1] 290647 0
Approval date [1] 290647 0
11/03/2014
Ethics approval number [1] 290647 0
14-CHREC-F003
Ethics committee name [2] 290648 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 290648 0
Ethics committee country [2] 290648 0
Australia
Date submitted for ethics approval [2] 290648 0
07/04/2014
Approval date [2] 290648 0
Ethics approval number [2] 290648 0
Ethics committee name [3] 309648 0
Central Adelaide Local Health Network
Ethics committee address [3] 309648 0
Ethics committee country [3] 309648 0
Australia
Date submitted for ethics approval [3] 309648 0
Approval date [3] 309648 0
06/01/2016
Ethics approval number [3] 309648 0
HREC/15/TQEH/118 SSA/15/TQEH/271

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

Contacts
Principal investigator
Name 46410 0
Dr Tasha Stanton
Address 46410 0
The University of South Australia
School of Health Science
GPO Box 2471
Adelaide, South Australia
5001
Country 46410 0
Australia
Phone 46410 0
+61883022090
Fax 46410 0
Email 46410 0
[email protected]
Contact person for public queries
Name 46411 0
Tasha Stanton
Address 46411 0
The University of South Australia
School of Health Science
GPO Box 2471
Adelaide, South Australia
5001
Country 46411 0
Australia
Phone 46411 0
+61883022090
Fax 46411 0
Email 46411 0
[email protected]
Contact person for scientific queries
Name 46412 0
Tasha Stanton
Address 46412 0
The University of South Australia
School of Health Science
GPO Box 2471
Adelaide, South Australia
5001
Country 46412 0
Australia
Phone 46412 0
+61883022090
Fax 46412 0
Email 46412 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified clinical data
When will data be available (start and end dates)?
Available Jan 2022 onwards
Available to whom?
Researchers
Available for what types of analyses?
Longitudinal studies on prevalence and predictive studies on outcome after TKR.
How or where can data be obtained?
Email primary investigator


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.