Total Knee ArthroplastyNCT01466920
Why Are so Many Patients Dissatisfied With Knee Replacement Surgery? Exploring Variations of the Patient Experience
An observational study of Total Knee Arthroplasty, run by University of British Columbia at 7 sites in Canada.
Trial summary
The goal of this research is to fill the knowledge gap relating to why up to 20 percent of total knee arthroplasty (TKA) patients are dissatisfied with their clinical outcomes and to answer the research question: What are the drivers of variation in the patient experience with primary (ie. not revision) TKA? Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- How many people
- 515 participants
- Where
- 7 sitesCanada
- Study dates
- Nov 2011to Dec 2015
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing total knee arthroplasty
Who may be able to join
- Adults 19 and older
- Primary or secondary diagnosis of osteoarthritis or inflammatory arthritis
- Scheduled to undergo primary TKA
- Living in British Columbia
- Capable of providing informed consent
Who cannot join
- Not having been diagnosed with osteoarthritis
- Inability to complete the study questionnaires
- Adults undergoing arthroplasty revision surgery
- Adults undergoing bilateral knee replacements
- Adults undergoing unicompartmental knee replacements
- Adults whose knee replacement is due to post-traumatic deformity Contacts and Locations
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Burnaby Hospital
Burnaby, British Columbia, V5G 2X6
Kelowna General Hospital
Kelowna, British Columbia, V1Y 3H5
University Hospital of Northern British Columbia
Prince George, British Columbia, V2M 1S2
Richmond Hospital
Richmond, British Columbia, V7C 5L9
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
University of British Columbia Hospital
Vancouver, British Columbia, V6T 2B5
VIHA Joint Replacement Clinic
Victoria, British Columbia, V8V3M9
About this study
The goal of this research is to fill the knowledge gap relating to why up to 20 percent of total knee arthroplasty (TKA) patients are dissatisfied with their clinical outcomes and to answer the research question: What are the drivers of variation in the patient experience with primary (ie. not revision) TKA?
Read the detailed description
Purpose: Among patients with a diagnosis of osteoarthritis and who are undergoing total knee arthroplasty:
- To identify variations in the patient experience with primary knee replacement surgery by measuring clinical outcomes, health status, and patient satisfaction; and
- To explore the factors contributing to good/poor clinical and patient outcomes, such as surgical factors, health system factors, socioeconomic demographic factors and psychological factors.
- Conditions
- Total Knee Arthroplasty
- Keywords
- Total knee arthroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2013
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stirling Bryan, PhD, Principal investigator, School of Population and Public Health, University of British ColumbiaJennifer Davis, PhD, Study director, University of British ColumbiaAlison Dormuth, Study director, BC Ministry of Health ServicesDenise Dunton, MN, Study director, Interior Health AuthorityVivian Giglio, Study director, Fraser Health AuthorityLaurie Goldsmith, MSc, PhD, Study director, Simon Fraser UniversityVal MacDonald, MSN, Study director, Fraser Health AuthorityPatrick McAllister, MD, Study director, Vancouver Island Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466920
- Sponsor's protocol ID
- H11-02117
- Status last verified
- Apr 2015
- First submitted
- 3 Nov 2011
- Last updated
- 9 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Why Are so Many Patients Dissatisfied With Knee Replacement Surgery? Exploring Variations of the Patient Experience
- ClinicalTrials.gov ID
- NCT01466920
- Acronym / sponsor ID
- H11-02117
- Conditions
- Total Knee Arthroplasty
- Keywords
- Total knee arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 515 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 8 Nov 2011 (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 goal of this research is to fill the knowledge gap relating to why up to 20 percent of total knee arthroplasty (TKA) patients are dissatisfied with their clinical outcomes and to answer the research question: What are the drivers of variation in the patient experience with primary (ie. not revision) TKA?
Detailed description
Purpose: Among patients with a diagnosis of osteoarthritis and who are undergoing total knee arthroplasty:
- To identify variations in the patient experience with primary knee replacement surgery by measuring clinical outcomes, health status, and patient satisfaction; and
- To explore the factors contributing to good/poor clinical and patient outcomes, such as surgical factors, health system factors, socioeconomic demographic factors and psychological factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing total knee arthroplasty
Key inclusion criteria (5 listed)
- Adults 19 and older
- Primary or secondary diagnosis of osteoarthritis or inflammatory arthritis
- Scheduled to undergo primary TKA
- Living in British Columbia
- Capable of providing informed consent
Key exclusion criteria (6 listed)
- Not having been diagnosed with osteoarthritis
- Inability to complete the study questionnaires
- Adults undergoing arthroplasty revision surgery
- Adults undergoing bilateral knee replacements
- Adults undergoing unicompartmental knee replacements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
Related trials for Total Knee Arthroplasty
Active, not recruiting
14022 ATTUNE Cementless RP Clinical Performance Evaluation
Osteoarthritis
Not yet recruiting
Patient Satisfaction After Robotic-Assisted Versus Conventional Total Knee Arthroplasty
Osteoarthritis (Knee), Robotic Assisted Arthroplasty
Active, not recruiting
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Arthroplasty, Replacement
Active, not recruiting
Healthy Living After Knee Replacement
Arthroplasty, Overweight and Obesity
Active, not recruiting
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Primary Knee Arthroplasty
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.
Stirling Bryan, PhD principal investigator
School of Population and Public Health, University of British Columbia
Jennifer Davis, PhD study director
University of British Columbia
Alison Dormuth study director
BC Ministry of Health Services
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty, run by University of British Columbia at 7 sites 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Results are not available in the source record.
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.
Where can I read the original study information?
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 9 Apr 2015.