NCT03058380

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
348

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

August 17, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

December 17, 2019

Status Verified

May 1, 2019

Enrollment Period

10 months

First QC Date

February 16, 2017

Last Update Submit

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.

Other: Stated-Preferences Evaluation Instrument

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.

Stated-Preferences Evaluation Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

ArthritisOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic Diseases

Study Officials

  • Richard C Mather III

    Duke University

    PRINCIPAL INVESTIGATOR

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

Locations