OsteoarthritisNCT01899443
Improving Services and Outcomes for Joint Replacement Patients
An observational study of Osteoarthritis, run by South West Sydney Local Health District at 18 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Observation
- How many people
- 1,900 participants
- Where
- 18 sitesAustralia
- Study dates
- Aug 2013to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing primary total hip or knee replacement in private or public hsopitals in Australia
Who may be able to join
- 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
Who cannot join
- Cognitive impairment / history of dementia
- Hip replacement for fracture
- Revision of previous joint replacement
- Under 18 years of age
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Australia18 sites
Concealed site 9 Private
Melbourne, Victoria
Concealed site 4 Public
Rural, New South Wales
Concealed site 6 Private
Rural, New South Wales
Concealed site 8 Private
Rural, New South Wales
Concealed site 15 Public
Rural, Queensland
Concealed site 16 Public
Semi Rural, New South Wales
Concealed site 1 Public
Sydney, New South Wales
Concealed site 17 Private
Sydney, New South Wales
Concealed site 2 Public
Sydney, New South Wales
Concealed Site 3 Public
Sydney, New South Wales
Concealed site 5 Private
Sydney, New South Wales
Concealed site 7 Private
Urban, New South Wales
Concealed site 13 Private
Urban, Queensland
Concealed site 14 Public
Urban, Queensland
Concealed site 12 Private
Urban, South Australia
Concealed site 11 Private
Urban, Tasmania
Concealed site 10 Public
Urban, Victoria
Concealed site 18 - 2 Public sites
Urban, Victoria
About this study
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.
Read the detailed description
The primary aim of the study is to identify whether compliance with specific processes is associated with better outcomes.
The study is a longitudinal cohort study to examine outcomes after total hip and knee replacement surgeries. We hypothesise the site and patient level compliance is related to the prevalence of a subsequent complication (composite outcome comprising 30 day mortality, readmission, reoperation or surgical complication).
METHODS This study will select high volume (>275 cases annually) public and private hospitals across Australia. By involving public and private sites across Australia, the generalisability of the findings is enhanced. Each site will identify a site coordinator to oversee and manage the project at that site. Site coordinators are identified by each site. After hospital discharge, patients are followed up by the investigators.
This is a prospective observational study with projected sample of c.2200 consenting patients from up to 20 high volume hospitals. The site coordinator will screen, approach and consent eligible patients during routine preadmission processes. At the time of consent, the patient will be required to: provide socio-demographic details about themselves, past medical history, complete 2 standard patient reported outcome measures. Contact with patients about the study will be made by the site coordinator and routine hospital staff involved in their acute care. Acute data collection will involve prospective audit of medical records to collect peri- and post- operative acute care process data, client characteristics and outcomes by staff at each site. Random and convenience sampling will be used to identify eligible hospital sites which will remain anonymous.
Patient follow up regarding longer term outcomes will be completed via telephone by study investigators at three additional time points (approximately 35 and 90 days and 1 year post surgery) to collect repeat data as provided by each patient at the time of consent.
Descriptive statistics will be used to profile site level and patient level compliance with key processes of care. Multivariable logistic regression (MLoR) will be used to identify the association between the binary composite outcome measure and patient level compliance. Site and individual patient compliance with evidence based guidelines (where available) or best practice recommendations on key processes and relevant outcomes will be examined (e.g. Venous thromboembolism (VTE) prevention). Sample size calculations have been completed to ensure the analyses have sufficient power. If a useful association between processes and outcomes is identified, cost analyses with specific foci will be undertaken to consider costs for different factors and stages (e.g. acute / post discharge). Secondary analysis will determine the predictors of patient -reported outcomes. Depending on the results of initial data analyses, additional secondary analyses will potentially include analyses at additional time points (beyond initial 35 days) for association between key processes and outcomes, and analysis looking at the association between specific complications and compliance with specific processes.
Interim analysis will be undertaken to assess the level of observed compliance with key processes.
Re-abstraction of acute care data will be undertaken to ensure accuracy and completeness of submitted date from the sites.
Site survey Prior to study commencement at each site, the site coordinators will complete a survey detailing each surgeons protocols for key processes including their VTE and antimicrobial prophylaxes. The extent surgeon protocols align with Australian practice guidelines will be ascertained.
Additional secondary analyses will include, but may not be limited to:
- a comparison of outcomes between patients who go to inpatient rehabilitation and those who go directly home after surgery. Propensity based scoring and matching will be used to determine if outcomes are better in one of the two groups
- determination of the predictors of the 'unhappy knee' 12 months post surgery. A case controlled matched design will be used.
- comparison in satisfaction with the acute care experience between private and public patients in a subset
- a comparison of outcomes between THR patients with an anterior surgical approach and a posterior approach
- description of ambulation profiles immediately post surgery and variables associated with early ambulation
- snapshot of rehabilitation received after TKA or THA
- Conditions
- Osteoarthritis
- Being tested
- Observation
- Keywords
- total hip replacement, total knee replacement, patient outcomes, health services research
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
This is an observational study observing relationship between routine care and outcomes after total hip or knee arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants experiencing the composite outcome up to 35 days post surgery.
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.
Measured: 35 days post total hip or knee replacement surgery
Secondary outcomes (8)
Patient-reported quality of life
The EuroQual 5-level (EQ5D) assessment will be used to capture patient-reported quality of life.
Measured: 35 days post surgery
Incidence of venous thromboembolism
The number of patients treated with a documented blood clot
Measured: 90 days post surgery
Incidence of deep infection.
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.
Measured: 365 days post surgery
Costs of care processes
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.
Measured: 90 days post surgery
Patient reported quality of life (QoL)
The EQ5D will be used to capture patient-reported QoL
Measured: 90 days post surgery
Health-related QoL
The EQ5D will be used to capture QoL
Measured: 365 days post surgery
Patient reported joint pain and function
The Oxford Knee or Hip Score will be used to capture patient reported joint specific pain and function.
Measured: 90 days post surgery
Patient reported joint pain and function
The Oxford Knee or Hip Score will be used to capture patient reported joint specific pain and function
Measured: 365 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- South West Sydney Local Health District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justine Naylor, South West Sydney Local Health District
- Investigators
- Justine M Naylor, PhD,BAppSc (Phty), Principal investigator, Sydney South West Local health District, University of NSW, Ingham Institute for Applied Medical ResearchIan A Harris, PhD,MBBS, Principal investigator, Sydney South West Local health District, University of NSW, Ingham Institute for Applied Medical ResearchHelen M Badge, MApSc,BAScOT, Principal investigator, Ingham Institute for Applied Medical Research, University of NSWWei Xuan, PhD, Principal investigator, Ingham Institute Applied Medical ResearchChristine Lin, PhD, BApScPhty, Principal investigator, George Institute, University of Syndey, AustraliaElizabeth Armstrong, BAppScPhty, Principal investigator, University of NSW, Sydney, AustraliaKevin Bozic, MD MBA, Principal investigator, University of California, San FranciscoJohn Fletcher, PhD, MBBS, Principal investigator, University of Sydney, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899443
- Sponsor's protocol ID
- ISOAJRS_AU
- Status last verified
- Mar 2017
- First submitted
- 10 Jul 2013
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Johns N, Naylor J, McKenzie D, Brady B, Olver J. High pain reported at 3 months post-total knee arthroplasty often persists for the next 3 years and is associated with reduced function and quality of life. Musculoskeletal Care. 2024 Mar;22(1):e1866. doi: 10.1002/msc.1866.
PubMed 38348944Sidhu V, Badge H, Churches T, Maree Naylor J, Adie S, A Harris I. Comparative effectiveness of aspirin for symptomatic venous thromboembolism prophylaxis in patients undergoing total joint arthroplasty, a cohort study. BMC Musculoskelet Disord. 2023 Aug 3;24(1):629. doi: 10.1186/s12891-023-06750-x.
PubMed 37537580Jenkin DE, Harris IA, Descallar J, Naylor JM. Discharge to inpatient rehabilitation following arthroplasty is a strong predictor of persistent opioid use 90 days after surgery: a prospective, observational study. BMC Musculoskelet Disord. 2023 Jan 14;24(1):31. doi: 10.1186/s12891-023-06142-1.
PubMed 36639624Johns 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.
PubMed 36096816Naylor 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.
PubMed 30021552
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Services and Outcomes for Joint Replacement Patients
- ClinicalTrials.gov ID
- NCT01899443
- Acronym / sponsor ID
- ISOAJRS_AU
- Conditions
- Osteoarthritis
- Keywords
- total hip replacement, total knee replacement, patient outcomes, health services research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,900 participants (actual)
- Lead sponsor
- South West Sydney Local Health DistrictUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary aim of the study is to identify whether compliance with specific processes is associated with better outcomes.
The study is a longitudinal cohort study to examine outcomes after total hip and knee replacement surgeries. We hypothesise the site and patient level compliance is related to the prevalence of a subsequent complication (composite outcome comprising 30 day mortality, readmission, reoperation or surgical complication).
METHODS This study will select high volume (>275 cases annually) public and private hospitals across Australia. By involving public and private sites across Australia, the generalisability of the findings is enhanced. Each site will identify a site coordinator to oversee and manage the project at that site. Site coordinators are identified by each site. After hospital discharge, patients are followed up by the investigators.
This is a prospective observational study with projected sample of c.2200 consenting patients from up to 20 high volume hospitals. The site coordinator will screen, approach and consent eligible patients during routine preadmission processes. At the time of consent, the patient will be required to: provide socio-demographic details about themselves, past medical history, complete 2 standard patient reported outcome measures. Contact with patients about the study will be made by the site coordinator and routine hospital staff involved in their acute care. Acute data collection will involve prospective audit of medical records to collect peri- and post- operative acute care process data, client characteristics and outcomes by staff at each site. Random and convenience sampling will be used to identify eligible hospital sites which will remain anonymous.
Patient follow up regarding longer term outcomes will be completed via telephone by study investigators at three additional time points (approximately 35 and 90 days and 1 year post surgery) to collect repeat data as provided by each patient at the time of consent.
Descriptive statistics will be used to profile site level and patient level compliance with key processes of care. Multivariable logistic regression (MLoR) will be used to identify the association between the binary composite outcome measure and patient level compliance. Site and individual patient compliance with evidence based guidelines (where available) or best practice recommendations on key processes and relevant outcomes will be examined (e.g. Venous thromboembolism (VTE) prevention). Sample size calculations have been completed to ensure the analyses have sufficient power. If a useful association between processes and outcomes is identified, cost analyses with specific foci will be undertaken to consider costs for different factors and stages (e.g. acute / post discharge). Secondary analysis will determine the predictors of patient -reported outcomes. Depending on the results of initial data analyses, additional secondary analyses will potentially include analyses at additional time points (beyond initial 35 days) for association between key processes and outcomes, and analysis looking at the association between specific complications and compliance with specific processes.
Interim analysis will be undertaken to assess the level of observed compliance with key processes.
Re-abstraction of acute care data will be undertaken to ensure accuracy and completeness of submitted date from the sites.
Site survey Prior to study commencement at each site, the site coordinators will complete a survey detailing each surgeons protocols for key processes including their VTE and antimicrobial prophylaxes. The extent surgeon protocols align with Australian practice guidelines will be ascertained.
Additional secondary analyses will include, but may not be limited to:
- a comparison of outcomes between patients who go to inpatient rehabilitation and those who go directly home after surgery. Propensity based scoring and matching will be used to determine if outcomes are better in one of the two groups
- determination of the predictors of the 'unhappy knee' 12 months post surgery. A case controlled matched design will be used.
- comparison in satisfaction with the acute care experience between private and public patients in a subset
- a comparison of outcomes between THR patients with an anterior surgical approach and a posterior approach
- description of ambulation profiles immediately post surgery and variables associated with early ambulation
- snapshot of rehabilitation received after TKA or THA
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total hip and knee replacement patients | – | Other: ObservationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary total hip or knee replacement in private or public hsopitals in Australia
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Cognitive impairment / history of dementia
- Hip replacement for fracture
- Revision of previous joint replacement
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationThis is an observational study observing relationship between routine care and outcomes after total hip or knee arthroplasty. | Other | Total hip and knee replacement patients |
Primary outcome
Percentage of participants experiencing the composite outcome up to 35 days post surgery.
Time frame: 35 days post total hip or knee replacement surgery
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.
8 secondary outcomes
Patient-reported quality of life
Time frame: 35 days post surgery
Incidence of venous thromboembolism
Time frame: 90 days post surgery
Incidence of deep infection.
Time frame: 365 days post surgery
Costs of care processes
Time frame: 90 days post surgery
Patient reported quality of life (QoL)
Time frame: 90 days post surgery
Health-related QoL
Time frame: 365 days post surgery
Patient reported joint pain and function
Time frame: 90 days post surgery
Patient reported joint pain and function
Time frame: 365 days post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Derived from this study: PubMed 38348944Johns N, Naylor J, McKenzie D, Brady B, Olver J. High pain reported at 3 months post-total knee arthroplasty often persists for the next 3 years and is associated with reduced function and quality of life. Musculoskeletal Care. 2024 Mar;22(1):e1866. doi: 10.1002/msc.1866.
- Derived from this study: PubMed 37537580Sidhu V, Badge H, Churches T, Maree Naylor J, Adie S, A Harris I. Comparative effectiveness of aspirin for symptomatic venous thromboembolism prophylaxis in patients undergoing total joint arthroplasty, a cohort study. BMC Musculoskelet Disord. 2023 Aug 3;24(1):629. doi: 10.1186/s12891-023-06750-x.
- Derived from this study: PubMed 36639624Jenkin DE, Harris IA, Descallar J, Naylor JM. Discharge to inpatient rehabilitation following arthroplasty is a strong predictor of persistent opioid use 90 days after surgery: a prospective, observational study. BMC Musculoskelet Disord. 2023 Jan 14;24(1):31. doi: 10.1186/s12891-023-06142-1.
- Derived from this study: PubMed 36096816Johns 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.
- Derived from this study: PubMed 30021552Naylor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justine M Naylor, PhD,BAppSc (Phty) principal investigator
Sydney South West Local health District, University of NSW, Ingham Institute for Applied Medical Research
Ian A Harris, PhD,MBBS principal investigator
Sydney South West Local health District, University of NSW, Ingham Institute for Applied Medical Research
Helen M Badge, MApSc,BAScOT principal investigator
Ingham Institute for Applied Medical Research, University of NSW
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by South West Sydney Local Health District at 18 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants experiencing the composite outcome up to 35 days post surgery. (time frame: 35 days post total hip or knee replacement surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01899443, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.