Recruiting

Mobile App

Sponsor:

University of Toronto Orthopaedic Sports Medicine

Code:

NCT02942940

Conditions

Anterior Cruciate Ligament (ACL) Tear

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

mobile app

conventional in-person

Study Details

Brief summary:

Background: Telemedicine is increasingly used to overcome distance between patients and physicians. Preliminary studies suggest that mobile app follow-up care for ACL reconstruction patients is feasible, can avert in-person follow-up care, and is cost-effective.

Objective: To avert in-person follow-up through the use of a mobile app in the first six weeks after surgery.

Methods: This will be a single-center, prospective randomized controlled trial

Results: Data to be analyzed from 72 patients.

Conditions

Anterior Cruciate Ligament (ACL) Tear

Study ID

NCT02942940

Start date

Oct, 2016

Status verified date

Oct, 2016

Completion date

Apr, 2018

Anticipated

Primary completion date

Oct, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing ACL reconstruction at Women's College Hospital (WCH), between the ages of 18-70.
  • Patients must be able to use a mobile device and communicate in English.

Exclusion Criteria:

  • Patients who are smokers, as they carry increased rates of complications.
  • Patients must not:

  • Suffer from chronic pain
  • Be taking narcotic (morphine-like) medication for pain on a regular basis, and
  • Have an allergy to local anesthetics or morphine-like medications

  • Pain scores captured in the VAS and QoR-9 are important for judging post-operative recovery. Pre-existing pain or inability to take narcotics post-operatively would compromise the reliability of these measures.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: mobile app

active comparator: in-person

Interventions

mobile app

The mobile app follow-up group will have no planned in-person follow-up, however these visits will be replaced with surgical site examination via submitted photos, Visual Analogue Scale (VAS), and Quality of Recovery - 9 questionnaire (QoR-9) and limb specific recovery monitoring. All information is submitted with the mobile app (QoC Health Inc, Toronto).

conventional in-person

Patients in the conventional follow-up group will have a planned clinic follow-up at 2 and 6 weeks post-operatively, which is the schedule currently used by our surgeons. At these scheduled follow-up visits, patients will be asked to complete the VAS to assess pain and the QoR-9 in addition to recovery questions about their operated extremity.

Primary outcome measure

  • Required physician visits [ Time Frame: 6 weeks post surgery ]

Central Contacts and Locations

Locations

Women's College Hospital

Recruiting

Toronto, Ontario, Canada, M5S1B1

Contacts

James Higgins, MD

jhiggins@qmed.ca

Jennie Gillis

6474053848j.gillis@utosm.com

Principal Investigator:

John Theodoropoulos, MD

More Information

Sponsor

University of Toronto Orthopaedic Sports Medicine

Last update posted

Oct 25, 2016

Last verified

Oct, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto Orthopaedic Sports Medicine on 2016-10-25.