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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01899443
Registration number
NCT01899443
Ethics application status
Date submitted
10/07/2013
Date registered
15/07/2013
Date last updated
24/03/2017
Titles & IDs
Public title
Improving Services and Outcomes for Joint Replacement Patients
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Scientific title
Improving Services and Outcomes for Joint Replacement Patients
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Secondary ID [1]
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ISOAJRS_AU
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Observation
Total hip and knee replacement patients - This study will select up to 20 high volume (>275 cases annually) public and private hospitals across Australia. A random sample of c.2200 patients with diagnosis of osteoarthritis undergoing primary total hip or knee replacement surgery will be recruited.
Other interventions: Observation
This is an observational study observing relationship between routine care and outcomes after total hip or knee arthroplasty.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of participants experiencing the composite outcome up to 35 days post surgery.
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Assessment method [1]
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The proportion of patients in each group (compliant and non-compliant groups) that experience one or more of the following outcomes - death, readmission, reoperation or surgical complication - up to 35 days post-surgery. Analyses will adjust for patient and service provider confounders.
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Timepoint [1]
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35 days post total hip or knee replacement surgery
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Secondary outcome [1]
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Patient-reported quality of life
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Assessment method [1]
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The EuroQual 5-level (EQ5D) assessment will be used to capture patient-reported quality of life.
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Timepoint [1]
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35 days post surgery
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Secondary outcome [2]
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Incidence of venous thromboembolism
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Assessment method [2]
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The number of patients treated with a documented blood clot
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Timepoint [2]
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90 days post surgery
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Secondary outcome [3]
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Incidence of deep infection.
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Assessment method [3]
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The number of patients with a documented deep infection. That is, were treated with intravenous antibiotics for their index joint, was readmitted to hospital, and/or had a joint washout.
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Timepoint [3]
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365 days post surgery
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Secondary outcome [4]
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Costs of care processes
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Assessment method [4]
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The cost of individual care processes, the cost of healthcare utilisation post discharge from acute care, carer costs and cost of time off work will be calculated for each person. Data will be collected using patient diaries and derived from the acute care study data.
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Timepoint [4]
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90 days post surgery
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Secondary outcome [5]
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Patient reported quality of life (QoL)
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Assessment method [5]
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The EQ5D will be used to capture patient-reported QoL
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Timepoint [5]
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90 days post surgery
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Secondary outcome [6]
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Health-related QoL
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Assessment method [6]
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The EQ5D will be used to capture QoL
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Timepoint [6]
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365 days post surgery
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Secondary outcome [7]
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Patient reported joint pain and function
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Assessment method [7]
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The Oxford Knee or Hip Score will be used to capture patient reported joint specific pain and function.
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Timepoint [7]
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90 days post surgery
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Secondary outcome [8]
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Patient reported joint pain and function
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Assessment method [8]
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The Oxford Knee or Hip Score will be used to capture patient reported joint specific pain and function
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Timepoint [8]
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365 days post surgery
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Eligibility
Key inclusion criteria
- Primary elective unilateral or bilateral total knee arthroplasty (TKA) or total hip
arthroplasty (THA)
- Primary diagnosis of osteoarthritis
- Aged 18 or over, either gender
- Able to comprehend the protocol and provide consent (e.g. be able to read English,
have no history of dementia)
- Available for telephone follow-up within the first 6 weeks, 3 months and then at 12
months post surgery
- No further joint replacement surgery planned within the next 3 months of the current
surgery
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Minimum age
18
Years
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Maximum age
No limit
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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
- Cognitive impairment / history of dementia
- Hip replacement for fracture
- Revision of previous joint replacement
- Under 18 years of age
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2016
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Sample size
Target
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Accrual to date
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Final
1900
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
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Recruitment hospital [1]
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Concealed site 4 Public - Rural
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Recruitment hospital [2]
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Concealed site 6 Private - Rural
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Recruitment hospital [3]
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Concealed site 8 Private - Rural
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Recruitment hospital [4]
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Concealed site 16 Public - Semi Rural
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Recruitment hospital [5]
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Concealed site 1 Public - Sydney
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Recruitment hospital [6]
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Concealed site 17 Private - Sydney
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Recruitment hospital [7]
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Concealed site 2 Public - Sydney
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Recruitment hospital [8]
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Concealed Site 3 Public - Sydney
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Recruitment hospital [9]
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Concealed site 5 Private - Sydney
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Recruitment hospital [10]
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Concealed site 7 Private - Urban
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Recruitment hospital [11]
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Concealed site 15 Public - Rural
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Recruitment hospital [12]
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Concealed site 13 Private - Urban
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Recruitment hospital [13]
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Concealed site 14 Public - Urban
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Recruitment hospital [14]
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Concealed site 12 Private - Urban
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Recruitment hospital [15]
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Concealed site 11 Private - Urban
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Recruitment hospital [16]
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Concealed site 9 Private - Melbourne
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Recruitment hospital [17]
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Concealed site 10 Public - Urban
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Recruitment hospital [18]
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Concealed site 18 - 2 Public sites - Urban
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Recruitment postcode(s) [1]
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- Rural
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Recruitment postcode(s) [2]
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- Semi Rural
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Recruitment postcode(s) [3]
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- Sydney
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Recruitment postcode(s) [4]
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- Urban
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Recruitment postcode(s) [5]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
South West Sydney Local Health District
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Primary total knee or total hip replacement surgeries are costly high volume procedures &
outcomes may be affected by surgical & care processes & individual patient characteristics.
The primary hypotheses is that non compliance with recommended practice impacts patient
outcomes (e.g. the likelihood of complications following surgery). The primary aims of the
study are to evaluate the links between processes & outcomes & if possible develop a model
that will improve patient outcomes & reduce unnecessary practice variation whilst considering
costs.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01899443
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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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Justine M Naylor, PhD,BAppSc (Phty)
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Address
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Sydney South West Local health District, University of NSW, Ingham Institute for Applied Medical Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01899443
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