NCT04302077

Brief Summary

This is a prospective, randomized study designed to evaluate the effects of different initial postoperative follow-up modalities. Given the nature of the study, it is not possible for either the surgeons or the subjects to be blinded. Patients will be assigned to either group based on the last digit of their medical record number (MRN). Patients with an even-ending medical record number will be randomized to virtual visit/telemedicine, while patients with an odd-ending medical record number will be randomized to the office visit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

March 15, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

January 31, 2022

Status Verified

January 1, 2022

Enrollment Period

1 year

First QC Date

March 6, 2020

Last Update Submit

January 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in patient satisfaction

    Participant satisfaction will be measured by a electronic survey . At the conclusion of the in-person or virtual visit, participants will be provided instructions how to access the survey questions through the QR code if in-person and through a secure link if at home via telemedicine through EPIC.

    3 month follow up visit

Study Arms (2)

Telemedicine Post Op

ACTIVE COMPARATOR

Patients with an even-ending medical record number (0,2,4,6,8) will be randomized to virtual visit/telemedicine. This will be done by using Epic and MyChart-integrated telemedicine functionality for video visits with the Principal Investigator's patients. This is considered standard of care.

Other: virtual doctor visit

In-Office Post Op

ACTIVE COMPARATOR

Patients with an odd-ending medical record number (1,3,5,7,9) will be randomized to the office visit.

Other: Standard care doctor's visit

Interventions

interactive live-video feed at home through EPIC

Telemedicine Post Op

In person visit as per standard of care

In-Office Post Op

Eligibility Criteria

Age18 Years - 70 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants undergoing arthroscopic hip surgery

You may not qualify if:

  • Age \< 18 years old or Age \> 70 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Guillem Gonzalez-Lomas

    NYU Langone

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 10, 2020

Study Start

March 15, 2020

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

January 31, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to jordan.fried@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations