Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
Query!
Scientific title
Improving Services and Outcomes for Joint Replacement Patients
Query!
Secondary ID [1]
0
0
ISOAJRS_AU
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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.
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of participants experiencing the composite outcome up to 35 days post surgery.
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
35 days post total hip or knee replacement surgery
Query!
Secondary outcome [1]
0
0
Patient-reported quality of life
Query!
Assessment method [1]
0
0
The EuroQual 5-level (EQ5D) assessment will be used to capture patient-reported quality of life.
Query!
Timepoint [1]
0
0
35 days post surgery
Query!
Secondary outcome [2]
0
0
Incidence of venous thromboembolism
Query!
Assessment method [2]
0
0
The number of patients treated with a documented blood clot
Query!
Timepoint [2]
0
0
90 days post surgery
Query!
Secondary outcome [3]
0
0
Incidence of deep infection.
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
365 days post surgery
Query!
Secondary outcome [4]
0
0
Costs of care processes
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
90 days post surgery
Query!
Secondary outcome [5]
0
0
Patient reported quality of life (QoL)
Query!
Assessment method [5]
0
0
The EQ5D will be used to capture patient-reported QoL
Query!
Timepoint [5]
0
0
90 days post surgery
Query!
Secondary outcome [6]
0
0
Health-related QoL
Query!
Assessment method [6]
0
0
The EQ5D will be used to capture QoL
Query!
Timepoint [6]
0
0
365 days post surgery
Query!
Secondary outcome [7]
0
0
Patient reported joint pain and function
Query!
Assessment method [7]
0
0
The Oxford Knee or Hip Score will be used to capture patient reported joint specific pain and function.
Query!
Timepoint [7]
0
0
90 days post surgery
Query!
Secondary outcome [8]
0
0
Patient reported joint pain and function
Query!
Assessment method [8]
0
0
The Oxford Knee or Hip Score will be used to capture patient reported joint specific pain and function
Query!
Timepoint [8]
0
0
365 days post surgery
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Cognitive impairment / history of dementia
* Hip replacement for fracture
* Revision of previous joint replacement
* Under 18 years of age
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/08/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/12/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1900
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Query!
Recruitment hospital [1]
0
0
Concealed site 4 Public - Rural
Query!
Recruitment hospital [2]
0
0
Concealed site 6 Private - Rural
Query!
Recruitment hospital [3]
0
0
Concealed site 8 Private - Rural
Query!
Recruitment hospital [4]
0
0
Concealed site 16 Public - Semi Rural
Query!
Recruitment hospital [5]
0
0
Concealed site 1 Public - Sydney
Query!
Recruitment hospital [6]
0
0
Concealed site 17 Private - Sydney
Query!
Recruitment hospital [7]
0
0
Concealed site 2 Public - Sydney
Query!
Recruitment hospital [8]
0
0
Concealed Site 3 Public - Sydney
Query!
Recruitment hospital [9]
0
0
Concealed site 5 Private - Sydney
Query!
Recruitment hospital [10]
0
0
Concealed site 7 Private - Urban
Query!
Recruitment hospital [11]
0
0
Concealed site 15 Public - Rural
Query!
Recruitment hospital [12]
0
0
Concealed site 13 Private - Urban
Query!
Recruitment hospital [13]
0
0
Concealed site 14 Public - Urban
Query!
Recruitment hospital [14]
0
0
Concealed site 12 Private - Urban
Query!
Recruitment hospital [15]
0
0
Concealed site 11 Private - Urban
Query!
Recruitment hospital [16]
0
0
Concealed site 9 Private - Melbourne
Query!
Recruitment hospital [17]
0
0
Concealed site 10 Public - Urban
Query!
Recruitment hospital [18]
0
0
Concealed site 18 - 2 Public sites - Urban
Query!
Recruitment postcode(s) [1]
0
0
- Rural
Query!
Recruitment postcode(s) [2]
0
0
- Semi Rural
Query!
Recruitment postcode(s) [3]
0
0
- Sydney
Query!
Recruitment postcode(s) [4]
0
0
- Urban
Query!
Recruitment postcode(s) [5]
0
0
- Melbourne
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
South West Sydney Local Health District
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01899443
Query!
Trial related presentations / publications
Johns N, Naylor J, McKenzie D, Brady B, Olver J. Is inpatient rehabilitation a predictor of a lower incidence of persistent knee pain 3-months following total knee replacement? A retrospective, observational study. BMC Musculoskelet Disord. 2022 Sep 12;23(1):855. doi: 10.1186/s12891-022-05800-0. Naylor JM, Hart A, Mittal R, Harris IA, Xuan W. The effectiveness of inpatient rehabilitation after uncomplicated total hip arthroplasty: a propensity score matched cohort. BMC Musculoskelet Disord. 2018 Jul 18;19(1):236. doi: 10.1186/s12891-018-2134-3.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Justine M Naylor, PhD,BAppSc (Phty)
Query!
Address
0
0
Sydney South West Local health District, University of NSW, Ingham Institute for Applied Medical Research
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01899443
Download to PDF