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Stated-Preferences in Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03058380
Recruitment Status : Completed
First Posted : February 20, 2017
Last Update Posted : December 17, 2019
Sponsor:
Collaborators:
Duke Clinical Research Institute
Zimmer Biomet
Information provided by (Responsible Party):
Duke University

Study Description
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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.

Condition or disease Intervention/treatment
Arthritis Knee Osteoarthritis Arthropathy of Knee Other: Stated-Preferences Evaluation Instrument

Study Design
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Study Type : Observational
Actual Enrollment : 348 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Examining Stated-Preferences in Knee Arthroplasty: Unicompartmental Knee Arthroplasty (UKA) or Total Knee Arthroplasty (TKA)
Actual Study Start Date : August 17, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Patient Preference Measurements [ Time Frame: 20 minutes ]
    Patient-stated preferences regarding treatment for knee pain based on questionnaires


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Orthopaedic Clinics, Adult Reconstructive Surgery Clinics
Criteria

Inclusion Criteria:

  • Age 40-80
  • Knee Pain

Exclusion Criteria:

  • Inability to read, understand and give effective English consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058380


Locations
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United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Duke Clinical Research Institute
Zimmer Biomet
Investigators
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Principal Investigator: Richard C Mather III Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03058380    
Other Study ID Numbers: Pro00079625
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
 Arthritis
Musculoskeletal Diseases
Rheumatic Diseases