Improving Services and Outcomes for Joint Replacement Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-12-31

Brief Summary

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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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Detailed Description

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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:

1. 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
2. determination of the predictors of the 'unhappy knee' 12 months post surgery. A case controlled matched design will be used.
3. comparison in satisfaction with the acute care experience between private and public patients in a subset
4. a comparison of outcomes between THR patients with an anterior surgical approach and a posterior approach
5. description of ambulation profiles immediately post surgery and variables associated with early ambulation
6. snapshot of rehabilitation received after TKA or THA

Conditions

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Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Observation

Intervention Type OTHER

This is an observational study observing relationship between routine care and outcomes after total hip or knee arthroplasty.

Interventions

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Observation

This is an observational study observing relationship between routine care and outcomes after total hip or knee arthroplasty.

Intervention Type OTHER

Eligibility Criteria

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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

Exclusion Criteria

* Cognitive impairment / history of dementia
* Hip replacement for fracture
* Revision of previous joint replacement
* Under 18 years of age

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Justine Naylor

Senior Principal Research Fellow; Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Justine M Naylor, PhD,BAppSc (Phty)

Role: PRINCIPAL_INVESTIGATOR

Sydney South West Local health District, University of NSW, Ingham Institute for Applied Medical Research

Ian A Harris, PhD,MBBS

Role: PRINCIPAL_INVESTIGATOR

Sydney South West Local health District, University of NSW, Ingham Institute for Applied Medical Research

Helen M Badge, MApSc,BAScOT

Role: PRINCIPAL_INVESTIGATOR

Ingham Institute for Applied Medical Research, University of NSW

Wei Xuan, PhD

Role: PRINCIPAL_INVESTIGATOR

Ingham Institute Applied Medical Research

Christine Lin, PhD, BApScPhty

Role: PRINCIPAL_INVESTIGATOR

George Institute, University of Syndey, Australia

Elizabeth Armstrong, BAppScPhty

Role: PRINCIPAL_INVESTIGATOR

University of NSW, Sydney, Australia

Kevin Bozic, MD MBA

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

John Fletcher, PhD, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of Sydney, Australia

Iain Gosbell, PhD, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of Western Sydney, Australia

Locations

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Concealed site 4 Public

Rural, New South Wales, Australia

Site Status

Concealed site 6 Private

Rural, New South Wales, Australia

Site Status

Concealed site 8 Private

Rural, New South Wales, Australia

Site Status