Stated-Preferences in Knee Arthroplasty

December 16, 2019 updated by: Duke University

Examining Stated-Preferences in Knee Arthroplasty: Unicompartmental Knee Arthroplasty (UKA) or Total Knee Arthroplasty (TKA)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

348

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

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Health System

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Orthopaedic Clinics, Adult Reconstructive Surgery Clinics

Description

Inclusion Criteria:

  • Age 40-80
  • Knee Pain

Exclusion Criteria:

  • Inability to read, understand and give effective English consent

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Preference Measurements
Time Frame: 20 minutes
Patient-stated preferences regarding treatment for knee pain based on questionnaires
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Zimmer Biomet
Duke Clinical Research Institute

Investigators

  • Principal Investigator: Richard C Mather III, Duke 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 (Actual)

August 17, 2017

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

February 16, 2017

First Submitted That Met QC Criteria

February 16, 2017

First Posted (Actual)

February 20, 2017

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00079625

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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