- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01466920
Why Are so Many Patients Dissatisfied With Knee Replacement Surgery? Exploring Variations of the Patient Experience
April 7, 2015 updated by: University of British Columbia
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?
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Actual)
515
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Burnaby, British Columbia, Canada, V5G 2X6
- Burnaby Hospital
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Kelowna, British Columbia, Canada, V1Y 3H5
- Kelowna General Hospital
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Prince George, British Columbia, Canada, V2M 1S2
- University Hospital of Northern British Columbia
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Richmond, British Columbia, Canada, V7C 5L9
- Richmond Hospital
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital
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Vancouver, British Columbia, Canada, V6T 2B5
- University of British Columbia Hospital
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Victoria, British Columbia, Canada, V8V3M9
- VIHA Joint Replacement Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing total knee arthroplasty
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stirling Bryan, PhD, School of Population and Public Health, University of British Columbia
- Study Director: Jennifer Davis, PhD, University of British Columbia
- Study Director: Alison Dormuth, BC Ministry of Health Services
- Study Director: Denise Dunton, MN, Interior Health Authority
- Study Director: Vivian Giglio, Fraser Health Authority
- Study Director: Laurie Goldsmith, MSc, PhD, Simon Fraser University
- Study Director: Val MacDonald, MSN, Fraser Health Authority
- Study Director: Patrick McAllister, MD, Vancouver Island Health Authority
- Study Director: Rick Sawatzky, PhD, RN, Trinity Western University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
August 1, 2013
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
November 3, 2011
First Submitted That Met QC Criteria
November 3, 2011
First Posted (Estimate)
November 8, 2011
Study Record Updates
Last Update Posted (Estimate)
April 9, 2015
Last Update Submitted That Met QC Criteria
April 7, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H11-02117
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Limacorporate S.p.aRecruitingTotal Knee Arthroplasty | Revision Total Knee ArthroplastyUnited Kingdom, Portugal, Slovakia
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Copenhagen University Hospital, HvidovreUniversity of Southern Denmark; University Hospital Bispebjerg and FrederiksbergNot yet recruitingKnee Arthroplasty | Total Knee Arthroplasty | Unicompartmental Knee Arthroplasty
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DePuy OrthopaedicsJohnson & Johnson Health and Wellness Solutions, Inc.TerminatedTotal Knee Arthroplasty; Total Hip ArthroplastyUnited States
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DePuy OrthopaedicsJohnson & Johnson Health and Wellness Solutions, Inc.TerminatedTotal Knee Arthroplasty; Total Hip ArthroplastyUnited States
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University of North Carolina, Chapel HillNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedKnee Arthroplasty, Total | Knee Replacement, TotalUnited States
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Istanbul UniversityCompleted
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