Stated-Preferences in Knee Arthroplasty

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03058380
• Collaborator: Duke Clinical Research Institute (Other), Zimmer Biomet (Industry)
• Enrollment: 348
• Location: 1
• Actual Duration (Months): 9.5
• Patients Per Site Per Month: 36.8

Study Details

Study Description

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	Phase
Arthritis; Knee Osteoarthritis; Arthropathy of Knee	Other: Stated-Preferences Evaluation Instrument

Study Design

• 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: Aug 17, 2017
• Actual Primary Completion Date: Jun 1, 2018
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	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

Primary Outcome Measures

1. Patient Preference Measurements [20 minutes]

   Patient-stated preferences regarding treatment for knee pain based on questionnaires

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 40-80

• Knee Pain

Exclusion Criteria:

• Inability to read, understand and give effective English consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Health System	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University
• Duke Clinical Research Institute
• Zimmer Biomet

Investigators

• Principal Investigator: Richard C Mather III, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03058380
• Other Study ID Numbers: Pro00079625
• First Posted: Feb 20, 2017
• Last Update Posted: Dec 17, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Joint Diseases

Study Results

No Results Posted as of Dec 17, 2019