Arthroplasty, Replacement, HipNCT00277186
Alberta Hip and Knee Replacement Project
A study testing New Care Continuum in people with Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by Alberta Bone and Joint Health Institute at 1 site in Canada.
Trial summary
The study aims to determine if a New Arthroplasty Care Model, established on evidence-based medicine and best practices, will improve patient outcomes and improve cost effectiveness for patients with severe degenerative joint disease of the hip or knee in Alberta Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- What is being tested?
- New Care Continuum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,434 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2005to May 2006
- Phase
- Interventional
- 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
Who may be able to join
- Patient is at least 18 years of age
- Patient is able to provide written consent
Who cannot join
- Patient has previously undergone arthroplasty of the same hip or knee (revision)
- Patient has a surgical date scheduled for arthroplasty
- Patient requires a hip resurfacing procedure or an oxford knee
- Patient has a concurrent medical condition that would contraindicate the patients' ability to participate fully in the study procedures, including terminal conditions such as chronic obstructive pulmonary disease, end stage renal disease, heart failure, malignancy with an anticipated life expectancy of ≤ 2 years
- Patient has senile dementia or Alzheimer's disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Prospective Study to Examine the Effectiveness of a New Evidence Based Arthroplasty Care Model for Patients With Severe Degenerative Joint Disease (DJD) of the Hip or Knee in Alberta
The study aims to determine if a New Arthroplasty Care Model, established on evidence-based medicine and best practices, will improve patient outcomes and improve cost effectiveness for patients with severe degenerative joint disease of the hip or knee in Alberta
Read the detailed description
The Alberta Orthopaedic Society through its Arthroplasty Service Design Working Group has, after carefully reviewing the existing conventional approach to arthroplasty care, developed what they believe could be a much improved new evidence based arthroplasty care model. This model represents how ideally a patient would access and receive health services across the complete continuum of care. In addition, wherever possible, evidence gathered from the literature and from "known best practices" has been utilized to develop standards related to access, wait times, clinical quality, resource use and health outcome measures. Where no evidence or "known best practices" exist, a standard that best support achieving other known standards are being developed. This new evidence based arthroplasty model seeks to significantly minimize and where possible, eliminate all the current gaps and barriers to arthroplasty care.
This study will seek to prove that the new evidence based arthroplasty model will deliver improved patient outcomes with improved cost effectiveness. Once proven, it is anticipated that this new evidence based arthroplasty model will become the standard of care in Alberta, and a model for other jurisdictions to use in their health service re-designs
- Being tested
- New Care Continuum
- Keywords
- Arthroplasty, Health services research, Intent to treat, Randomized, Controlled
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Care ContinuumOther
Patient experience surgery through newly designed arthroplasty continuum
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Patients entering new care continuum Receives: Other: New Care Continuum |
| Control | Active comparator | Patient enter existing conventional approach Receives: Other: New Care Continuum |
What is being measured
The primary outcome is the main question the study is designed to answer.
health related quality of life scores
Measured: 3 month and 12 months post-surgery
Secondary outcomes (6)
health resource utilization
Measured: 3 month and 12 months post-surgery
wait time
Measured: Pre-surgery
safety
Measured: 3 month and 12 months post-surgery
cost utility
Measured: 3 month and 12 months post-surgery
patient satisfaction
Measured: 3 month and 12 months post-surgery
provider satisfaction
Measured: 3 month and 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startApr 2005
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, HipStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alberta Bone and Joint Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Medical Association, Calgary Health Region, David Thompson Health Region, Capital Health Region, Alberta Health & Wellness
- Investigators
- Cyril Frank, MD, Principal investigator, University of CalgaryBill Johnston, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277186
- Sponsor's protocol ID
- ARTH-00001
- Status last verified
- Jul 2008
- First submitted
- 13 Jan 2006
- Last updated
- 29 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gooch K, Marshall DA, Faris PD, Khong H, Wasylak T, Pearce T, Johnston DW, Arnett G, Hibbert J, Beaupre LA, Zernicke RF, Frank C. Comparative effectiveness of alternative clinical pathways for primary hip and knee joint replacement patients: a pragmatic randomized, controlled trial. Osteoarthritis Cartilage. 2012 Oct;20(10):1086-94. doi: 10.1016/j.joca.2012.06.017. Epub 2012 Jul 11.
PubMed 22796513
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Prospective Study to Examine the Effectiveness of a New Evidence Based Arthroplasty Care Model for Patients With Severe Degenerative Joint Disease (DJD) of the Hip or Knee in Alberta
- ClinicalTrials.gov ID
- NCT00277186
- Acronym / sponsor ID
- ARTH-00001
- Keywords
- Arthroplasty, Health services research, Intent to treat, Randomized, Controlled
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,434 participants (actual)
- Lead sponsor
- Alberta Bone and Joint Health InstituteUniversity, hospital or other
- Collaborators
- Alberta Medical Association, Calgary Health Region, David Thompson Health Region, Capital Health Region, Alberta Health & Wellness
- Study start
- Apr 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 16 Jan 2006 (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.
The study aims to determine if a New Arthroplasty Care Model, established on evidence-based medicine and best practices, will improve patient outcomes and improve cost effectiveness for patients with severe degenerative joint disease of the hip or knee in Alberta
Detailed description
The Alberta Orthopaedic Society through its Arthroplasty Service Design Working Group has, after carefully reviewing the existing conventional approach to arthroplasty care, developed what they believe could be a much improved new evidence based arthroplasty care model. This model represents how ideally a patient would access and receive health services across the complete continuum of care. In addition, wherever possible, evidence gathered from the literature and from "known best practices" has been utilized to develop standards related to access, wait times, clinical quality, resource use and health outcome measures. Where no evidence or "known best practices" exist, a standard that best support achieving other known standards are being developed. This new evidence based arthroplasty model seeks to significantly minimize and where possible, eliminate all the current gaps and barriers to arthroplasty care.
This study will seek to prove that the new evidence based arthroplasty model will deliver improved patient outcomes with improved cost effectiveness. Once proven, it is anticipated that this new evidence based arthroplasty model will become the standard of care in Alberta, and a model for other jurisdictions to use in their health service re-designs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: New Care ContinuumPatients entering new care continuum |
| Control | Active comparator | Other: New Care ContinuumPatient enter existing conventional approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is at least 18 years of age
- Patient is able to provide written consent
Key exclusion criteria (5 listed)
- Patient has previously undergone arthroplasty of the same hip or knee (revision)
- Patient has a surgical date scheduled for arthroplasty
- Patient requires a hip resurfacing procedure or an oxford knee
- Patient has a concurrent medical condition that would contraindicate the patients' ability to participate fully in the study procedures, including terminal conditions such as chronic obstructive pulmonary disease, end stage renal disease, heart failure, malignancy with an anticipated life expectancy of ≤ 2 years
- Patient has senile dementia or Alzheimer's disease
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 |
|---|---|---|
| New Care ContinuumPatient experience surgery through newly designed arthroplasty continuum | Other | Control, Intervention |
Primary outcome
health related quality of life scores
Time frame: 3 month and 12 months post-surgery
6 secondary outcomes
health resource utilization
Time frame: 3 month and 12 months post-surgery
wait time
Time frame: Pre-surgery
safety
Time frame: 3 month and 12 months post-surgery
cost utility
Time frame: 3 month and 12 months post-surgery
patient satisfaction
Time frame: 3 month and 12 months post-surgery
provider satisfaction
Time frame: 3 month and 12 months 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 29 Jul 2008.
- Derived from this study: PubMed 22796513Gooch K, Marshall DA, Faris PD, Khong H, Wasylak T, Pearce T, Johnston DW, Arnett G, Hibbert J, Beaupre LA, Zernicke RF, Frank C. Comparative effectiveness of alternative clinical pathways for primary hip and knee joint replacement patients: a pragmatic randomized, controlled trial. Osteoarthritis Cartilage. 2012 Oct;20(10):1086-94. doi: 10.1016/j.joca.2012.06.017. Epub 2012 Jul 11.
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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.
Cyril Frank, MD principal investigator
University of Calgary
Bill Johnston, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Care Continuum in people with Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by Alberta Bone and Joint Health Institute at 1 site in Canada.
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 2 inclusion and 5 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 29 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
health related quality of life scores (time frame: 3 month and 12 months post-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 NCT00277186, which also lists 1 linked publication.
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 29 Jul 2008.