Conventional Follow-up Versus Mobile App For Post-Operative ACL Reconstruction Patients

Study Overview
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Brief Summary
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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.

Official Title
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Conventional Follow-up Versus Mobile App Home Monitoring For Post-Operative Anterior Cruciate Ligament (ACL) Reconstruction Patients: A Randomized Controlled Trial

Conditions
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Anterior Cruciate Ligament (ACL) Tear

Intervention / Treatment
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* Device: mobile app
* Other: conventional in-person


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mobile app<br> | Device: mobile app<br>* 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).<br>|
| Active Comparator: in-person<br> | Other: conventional in-person<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Required physician visits | Total number of physician visits (including specialist, family physician, and ER) related to surgery | 6 weeks post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health care phone calls | Total number of health care telephone calls and emails (including specialist, family physician and ER) | 6 weeks post surgery |