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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03058380
Other study ID # Pro00079625
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 17, 2017
Est. completion date June 1, 2018

Study information

Verified date May 2019
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 348
Est. completion date June 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- Age 40-80

- Knee Pain

Exclusion Criteria:

- Inability to read, understand and give effective English consent

Study Design


Intervention

Other:
Stated-Preferences Evaluation Instrument
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.

Locations

Country Name City State
United States Duke University Health System Durham North Carolina

Sponsors (3)

Lead Sponsor Collaborator
Duke University Duke Clinical Research Institute, Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Preference Measurements Patient-stated preferences regarding treatment for knee pain based on questionnaires 20 minutes
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