NCT04108442

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. To reduce bias that may occur due to each surgeon's personal preference for postoperative follow-up modality, the surgeons (rather than individual subjects) will be randomized to one of two postoperative follow-up modality groups (traditional or virtual).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

August 1, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

October 9, 2020

Status Verified

October 1, 2020

Enrollment Period

7 months

First QC Date

August 22, 2019

Last Update Submit

October 8, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction with their surgeon

    Patients will report their satisfaction with their surgical experience 6 weeks after surgery using a 10-point Likert scale, 0-"Completely Dissatisfied, 10-"Completely Satisfied"

    6 Months

Study Arms (2)

Traditional

ACTIVE COMPARATOR
Behavioral: Traditional

Virtual

EXPERIMENTAL
Behavioral: Virtual

Interventions

TraditionalBEHAVIORAL

Surgeons (rather than individual subjects) will be randomized to traditional Postoperative follow-up modality groups. They will adhere to this form of postoperative follow-up for all of their surgical patients (subjects) for one month.

Traditional
VirtualBEHAVIORAL

Surgeons (rather than individual subjects) will be randomized to virtual postoperative follow-up modality group. They will adhere to that form of postoperative follow-up for all of their surgical patients (subjects) for one month.

Virtual

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \> 18 years old
  • \< 60 years old
  • Undergoing knee arthroscopy procedure

You may not qualify if:

  • \< 18 years old
  • \> 60 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

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kirk Campbell, MD

    New York Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2019

First Posted

September 30, 2019

Study Start

August 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

October 9, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (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.

Locations