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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02942940
Enrollment
32
Registered
2016-10-24
Start date
2016-10-31
Completion date
2018-04-30
Last updated
2016-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament (ACL) Tear

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.

Interventions

DEVICEmobile 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).

OTHERconventional 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.

Sponsors

University of Toronto Orthopaedic Sports Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Required physician visits6 weeks post surgeryTotal number of physician visits (including specialist, family physician, and ER) related to surgery

Secondary

MeasureTime frameDescription
Health care phone calls6 weeks post surgeryTotal number of health care telephone calls and emails (including specialist, family physician and ER)

Other

MeasureTime frameDescription
Cost of treatmentthrough study completion (approximately one year)cost of treatment related to surgery (i.e. rehabilitation, assistive devices)
Patient satisfaction with post-operative care6 weeks post surgerypatient satisfaction as recorded in the questionnaires (VAS) at 6 weeks post surgery

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026