Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT03834818

Conditions

Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

COMPAS Participants

Study Details

Brief summary:

The primary aim of this study is to measure pain and psychosocial patient reported outcomes, objective functionality, and actual daily at home opioid usage in orthopedic patients. The study's goal following the data collection is to predict which patients are at high risk for chronic opioid use.

Conditions

Surgery

Study ID

NCT03834818

Start date

Jan 13, 2025

Status verified date

May, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • aged 18-90 years old who are undergoing elective orthopedic surgery at Duke Health.
  • Patients must have their own smartphone IOS or Android device.
  • Patients must be able to read English.

Exclusion Criteria:

  • Lacking capacity to provide consent.
  • Cannot read English
  • Under 18 years of age
  • Older than 90 years of age

Study Design

Enrollment

10000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: COMPAS Participants

Patents between the ages of 18 and 90 who are undergoing orthopedic surgery at Duke Health will be eligible for enrollment.

Interventions

COMPAS Participants

The schedule of events for this study are as follows:

Day 1 Pre-Surgery:

  • Download the Medable App
  • Register to the study
  • Validated Questionnaires
  • Active Task

Every Day

  • 9:00 a.m. Daily Questions
  • 9:00 p.m. Daily Questions

Outcome Surveys and Active Task:

  • Day 1 Pre-Surgery
  • 1-Week Post Operation
  • 2-Weeks Post Operation
  • 1-Month Post Operation
  • 3-Months Post Operation
  • 6-Months Post Operation

Primary outcome measure

  • Reported Pain of Participants measured via PROMIS-29 [ Time Frame: 6 Months ]
  • Reported Pain of Participants measured via PROMIS-29 [ Time Frame: 6 Months ]
  • Reported Pain of Participants measured via Pain Catastrophizing pain scale. [ Time Frame: 6 Months ]
  • Opioid Use of Participants [ Time Frame: 6 months ]
  • Practicality of Mobile Application [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Ashley Burke

+1 919 681 2849ashley.burke@duke.edu

Michael Bullock, MD

+1 919 668 2024william.bullock@duke.edu

Locations

Duke Orthopaedics

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Neil D Ray, MD

919-681-1924neil.d.ray@duke.edu

More Information

Sponsor

Duke University

Last update posted

May 5, 2026

Last verified

May, 2026

Keywords

  • opioid use
  • pain
  • surgery
  • orthopedic surgery
  • orthopedic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-05-05.