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Trial registered on ANZCTR
Registration number
ACTRN12625001029482p
Ethics application status
Submitted, not yet approved
Date submitted
20/08/2025
Date registered
17/09/2025
Date last updated
17/09/2025
Date data sharing statement initially provided
17/09/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Early pain intervention after total knee replacement (EPIK): A registry-nested randomised controlled trial (RCT)
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Scientific title
Early pain intervention after total knee replacement (EPIK): A registry-nested randomised controlled trial (RCT)
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Secondary ID [1]
315114
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None
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Universal Trial Number (UTN)
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Trial acronym
EPIK
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis
338529
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Total knee replacement
338869
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Condition category
Condition code
Musculoskeletal
334835
334835
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0
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention group – EPIK model of care (in addition to usual care):
Within 2 weeks of randomisation, participants receive an initial ~1-hour telehealth assessment by a trial clinician trained in study procedures. The assessment reviews medical history, surgical information and patient-reported outcome measures, alongside additional questionnaires to identify prognostic factors for poor outcomes. Based on findings, the clinician develops a personalised care plan that refers participants to existing services based on their needs (e.g. orthopaedic surgeon, GP, physiotherapy, psychological services).
Participants are then followed up by the same clinician via telephone up to six times over 12 months (at ~2, 3, 4, 8, 9 and 10 months after the initial assessment). Follow-up calls last approximately 15–30 minutes and address progress, barriers, and further referrals if required.
Training: Trial clinicians will be trained using a manual that will be developed from extensive qualitative and co-design research. The manual’s authors will deliver training before trial commencement, and all clinicians will also complete Online Pain Education Network (OPEN) e-learning modules.
Adherence: Adherence will be assessed by the proportion of follow-up calls completed and the proportion of recommended services attended.
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Intervention code [1]
331738
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Rehabilitation
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Intervention code [2]
331740
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Treatment: Other
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Comparator / control treatment
Usual care: Follow-up and treatment consistent with local processes and surgeon preference following primary total knee replacement for osteoarthritis. This typically includes review by the surgeon and/or general practitioner and a standard rehabilitation program provided by local services at 6–12 weeks post-operatively. There are no specific restrictions placed on care-seeking in this group.
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Control group
Active
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Outcomes
Primary outcome [1]
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The Oxford Knee Score (OKS) is a validated patient-reported outcome measure that provides a composite score of both pain and function following total knee replacement. Accordingly, pain and function are assessed together as a composite primary outcome measure in this trial.
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Assessment method [1]
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Oxford Knee Score (OKS), a validated patient-reported outcome measure assessing pain and function after total knee replacement
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Timepoint [1]
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12 months post-randomisation (primary timepoint)
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Secondary outcome [1]
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Knee-specific pain and function
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Assessment method [1]
450932
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Oxford Knee Score (OKS)
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Timepoint [1]
450932
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6 months post-randomisation
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Secondary outcome [2]
450933
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Self-reported surgical complications
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Assessment method [2]
450933
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There is no validated questionnaire for this outcome. Participants will be asked simple study questions via the online follow-up questionnaire about whether they have experienced surgical complications such as infection, wound healing issues, or mechanical complications.
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Timepoint [2]
450933
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6 months post-randomisation
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Secondary outcome [3]
450934
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Pain intensity and pain interference will be assessed together as a validated composite outcome measure
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Assessment method [3]
450934
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Brief Pain Inventory (BPI)
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Timepoint [3]
450934
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6 and 12 months post-randomisation
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Secondary outcome [4]
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Health-related quality of life
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Assessment method [4]
450935
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EQ-5D-5L questionnaire
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Timepoint [4]
450935
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6 and 12 months post-randomisation
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Secondary outcome [5]
450936
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Satisfaction with surgical outcome and overall care post TKR will be assessed as a single composite secondary outcome
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Assessment method [5]
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Participant self-report
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Timepoint [5]
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6 and 12 months post-randomisation
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Secondary outcome [6]
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Reoperation for any reason Any additional surgical procedures related to the initial TKR
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Assessment method [6]
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Participant self-report and/or medical record review
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Timepoint [6]
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6 and 12 months post-randomisation
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Secondary outcome [7]
450938
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Revision joint replacement
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Assessment method [7]
450938
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Participant self-report and data linkage with AOA NJRR
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Timepoint [7]
450938
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6 and 12 months post-randomisation
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Secondary outcome [8]
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Hospital readmission (all cause)
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Assessment method [8]
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Participant self-report and/or medical record review
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Timepoint [8]
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6 and 12 months post-randomisation
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Secondary outcome [9]
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Anxiety and depression
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Assessment method [9]
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Hospital Anxiety and Depression Scale (HADS)
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Timepoint [9]
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6 and 12 months post-randomisation
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Secondary outcome [10]
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Pain catastrophising
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Assessment method [10]
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Pain Catastrophising Scale (PCS)
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Timepoint [10]
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6 and 12 months post-randomisation
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Secondary outcome [11]
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Mortality
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Assessment method [11]
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Mortality will be assessed via routine linkage with the Registry of Births, Deaths and Marriages conducted by the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR), which will provide these data for the EPIK trial.
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Timepoint [11]
450943
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6 and 12 months post-randomisation
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Secondary outcome [12]
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Health resource utilisation
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Assessment method [12]
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Patient diaries and linkage with Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) data
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Timepoint [12]
451696
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12 months post-randomisation
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Secondary outcome [13]
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Cost-effectiveness
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Assessment method [13]
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Economic evaluation combining trial records, administratively linked data (MBS, PBS), patient diaries, and EQ-5D-5L quality-adjusted life years (QALYs).
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Timepoint [13]
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12 months post-randomisation.
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Eligibility
Key inclusion criteria
Patients (aged greater than or equal to 18 years) undergoing primary total knee replacement for the diagnosis of osteoarthritis.
OKS pain subscale score of 14 or lower at 3 months after their TKR
Patients able to provide verbal and written consent in English
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients booked for a revision knee procedure at the time of consent
Lack of capacity to provide informed consent
Participation in another study that would interfere with the trial
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An independent statistician not involved in any aspect of the study will generate the randomisation sequence, thus ensuring allocation is concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into either the EPIK model of care or usual care alone at a 1:1 ratio using using minimisation based on the following factors: type of hospital (public vs. private), level of pain (OKS pain component score less than or equal to 7 vs. greater than 7), age (less than or equal to 65 vs. greater than 65 years), sex (male vs. female) and presence of complications requiring treatment after TKR (yes vs. no). Randomisation will be at the patient-level since there is minimal risk of contamination at 3 months post-operatively with the participant based in the community. The randomisation will be performed via an interactive web response service.
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/11/2025
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Actual
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Date of last participant enrolment
Anticipated
1/11/2028
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Actual
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Date of last data collection
Anticipated
1/11/2029
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Actual
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Sample size
Target
380
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council (NHMRC)
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Address [1]
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Country [1]
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Australia
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Funding source category [2]
319694
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Charities/Societies/Foundations
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Name [2]
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Ramsay Hospital Research Foundation
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Address [2]
319694
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Country [2]
319694
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Australia
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Primary sponsor type
University
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Name
The University of New South Wales
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Address
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Country
Australia
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Secondary sponsor category [1]
322198
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None
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Name [1]
322198
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NONE
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Address [1]
322198
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Country [1]
322198
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
318250
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Sydney Local Health District Ethics Review Committee (RPAH Zone)
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Ethics committee address [1]
318250
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https://www.slhd.nsw.gov.au/rpa/research/
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Ethics committee country [1]
318250
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Australia
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Date submitted for ethics approval [1]
318250
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08/09/2025
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Approval date [1]
318250
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Ethics approval number [1]
318250
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Summary
Brief summary
To determine the effectiveness of the EPIK model of care versus usual care alone, for adults with persistent pain at 3 months following Total Knee Replacement (TKR) surgery, in improving knee-specific function and pain at 12 months post intervention. To determine the safety, cost-effectiveness, influence of treatment adherence on treatment effects, and potential for national implementation of the EPIK model of care versus usual care alone, for adults with persistent pain following TKR.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Sam Adie
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Address
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UNSW SYDNEY, Suite 201, Level 2, 131 Princes Highway Cnr South St, Kogarah NSW 2217
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Country
143574
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Australia
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Phone
143574
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+61 2 9587 4720
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Fax
143574
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Email
143574
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[email protected]
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Contact person for public queries
Name
143575
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Khuong Duy Hoang
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Address
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Khuong Duy Hoang, Level 26, 201 Kent St, Sydney NSW 2000, Australia
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Country
143575
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Australia
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Phone
143575
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+61 8 8128 4405
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Fax
143575
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Email
143575
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[email protected]
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Contact person for scientific queries
Name
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Sam Adie
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Address
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UNSW Sydney, Suite 201, Level 2, 131 Princes Highway Cnr South St, Kogarah NSW 2217
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Country
143576
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Australia
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Phone
143576
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+61 2 9587 4720
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Fax
143576
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Email
143576
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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.
Download to PDF