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Improving Services and Outcomes for Joint Replacement Patients

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01899443
Recruitment Status : Completed
First Posted : July 15, 2013
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Justine Naylor, South West Sydney Local Health District

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.

Condition or disease Intervention/treatment
Osteoarthritis Other: Observation

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Study Type : Observational
Actual Enrollment : 1900 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Services and Outcomes for Joint Replacement Patients
Study Start Date : August 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Group/Cohort Intervention/treatment
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: Observation
This is an observational study observing relationship between routine care and outcomes after total hip or knee arthroplasty.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Patient-reported quality of life [ Time Frame: 35 days post surgery ]
    The EuroQual 5-level (EQ5D) assessment will be used to capture patient-reported quality of life.

  2. Incidence of venous thromboembolism [ Time Frame: 90 days post surgery ]
    The number of patients treated with a documented blood clot

  3. Incidence of deep infection. [ Time Frame: 365 days post surgery ]
    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.

  4. Costs of care processes [ Time Frame: 90 days post surgery ]
    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.

  5. Patient reported quality of life (QoL) [ Time Frame: 90 days post surgery ]
    The EQ5D will be used to capture patient-reported QoL

  6. Health-related QoL [ Time Frame: 365 days post surgery ]
    The EQ5D will be used to capture QoL

  7. Patient reported joint pain and function [ Time Frame: 90 days post surgery ]
    The Oxford Knee or Hip Score will be used to capture patient reported joint specific pain and function.

  8. Patient reported joint pain and function [ Time Frame: 365 days post surgery ]
    The Oxford Knee or Hip Score will be used to capture patient reported joint specific pain and function


Other Outcome Measures:
  1. Day of first ambulation attempt post surgery [ Time Frame: day 0-14 post-surgery ]

    The first post-operative day the patient walked, including any partial or full weight-bearing activities such as walking on the spot, bed-to-chair and bed-to-toilet).

    first post-operative day that patients walked, including any partial or full weight-bearing activities 134

    such as walking on the spot, bed-to-chair and bed-to-toilet).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing primary total hip or knee replacement in private or public hsopitals in Australia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899443


Locations
Show Show 18 study locations
Sponsors and Collaborators
South West Sydney Local Health District
Investigators
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Principal Investigator: Justine M Naylor, PhD,BAppSc (Phty) Sydney South West Local health District, University of NSW, Ingham Institute for Applied Medical Research
Principal Investigator: Ian A Harris, PhD,MBBS Sydney South West Local health District, University of NSW, Ingham Institute for Applied Medical Research
Principal Investigator: Helen M Badge, MApSc,BAScOT Ingham Institute for Applied Medical Research, University of NSW
Principal Investigator: Wei Xuan, PhD Ingham Institute Applied Medical Research
Principal Investigator: Christine Lin, PhD, BApScPhty George Institute, University of Syndey, Australia
Principal Investigator: Elizabeth Armstrong, BAppScPhty University of NSW, Sydney, Australia
Principal Investigator: Kevin Bozic, MD MBA University of California, San Francisco
Principal Investigator: John Fletcher, PhD, MBBS University of Sydney, Australia
Principal Investigator: Iain Gosbell, PhD, MBBS University of Western Sydney, Australia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Justine Naylor, Senior Principal Research Fellow; Director, South West Sydney Local Health District
ClinicalTrials.gov Identifier: NCT01899443    
Other Study ID Numbers: ISOAJRS_AU
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Keywords provided by Justine Naylor, South West Sydney Local Health District:
total hip replacement
total knee replacement
patient outcomes
health services research
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases