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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01466920
Other study ID # H11-02117
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 3, 2011
Last updated April 7, 2015
Start date November 2011
Est. completion date December 2015

Study information

Verified date April 2015
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical 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?


Description:

Purpose: Among patients with a diagnosis of osteoarthritis and who are undergoing total knee arthroplasty:

1. To identify variations in the patient experience with primary knee replacement surgery by measuring clinical outcomes, health status, and patient satisfaction; and

2. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 515
Est. completion date December 2015
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Burnaby Hospital Burnaby British Columbia
Canada Kelowna General Hospital Kelowna British Columbia
Canada University Hospital of Northern British Columbia Prince George British Columbia
Canada Richmond Hospital Richmond British Columbia
Canada University of British Columbia Hospital Vancouver British Columbia
Canada Vancouver General Hospital Vancouver British Columbia
Canada VIHA Joint Replacement Clinic Victoria British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

See also
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Active, not recruiting NCT04850300 - Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses Phase 3
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Completed NCT03206554 - Local Infiltration Analgesia in Total Knee Arthroplasty Phase 2
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Completed NCT01616836 - Optimizing Pain and Rehabilitation After Knee Arthroplasty Phase 3
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Completed NCT03289247 - Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty N/A
Terminated NCT03316118 - US Guided GNB vs Saline Injection for TKA Phase 4
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Enrolling by invitation NCT06188091 - Joint Movement to Increase Range of Motion in Knee Joint After Primary Total Knee Arthroplasty N/A