Stated-Preferences in Knee Arthroplasty
Examining Stated-Preferences in Knee Arthroplasty: Unicompartmental Knee Arthroplasty (UKA) or Total Knee Arthroplasty (TKA)
1 other identifier
observational
348
1 country
1
Brief Summary
The primary objectives of this study are to apply best-practice stated-preference methods to quantify patient preferences for benefit-risk tradeoffs associated with arthroplasty treatment options for end-stage osteoarthritis of the knee. Duke will develop and administer stated-preference surveys to adult patients (Ages 40-80) with knee pain to collect preference data, estimate the relative importance of treatment features and outcomes, and estimate maximum acceptable risks for given benefits and minimum acceptable benefits for given harms. This study proposal describes plans for the patient stated-preference survey.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2017
CompletedFirst Posted
Study publicly available on registry
February 20, 2017
CompletedStudy Start
First participant enrolled
August 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedDecember 17, 2019
May 1, 2019
10 months
February 16, 2017
December 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Patient Preference Measurements
Patient-stated preferences regarding treatment for knee pain based on questionnaires
20 minutes
Study Arms (1)
Stated-Preferences Evaluation Group
A stated-preferences evaluation instrument will be provided to participants with knee pain in the Stated-Preferences Evaluation Group. The instrument will measure patient preferences for total knee replacement versus unicompartmental knee replacement.
Interventions
A discrete choice experiment (Stated-Preferences Evaluation Instrument) will be electronically configured using best practice stated-preference methods to quantify preferences for total knee replacement versus unicompartmental knee replacement surgery.
Eligibility Criteria
Orthopaedic Clinics, Adult Reconstructive Surgery Clinics
You may qualify if:
- Age 40-80
- Knee Pain
You may not qualify if:
- Inability to read, understand and give effective English consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Duke Clinical Research Institutecollaborator
- Zimmer Biometcollaborator
Study Sites (1)
Duke University Health System
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard C Mather III
Duke University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2017
First Posted
February 20, 2017
Study Start
August 17, 2017
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
December 17, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share