Anterior Cruciate Ligament (ACL) TearNCT02942940
Conventional Follow-up Versus Mobile App For Post-Operative ACL Reconstruction Patients
A study testing mobile app and conventional in-person in people with Anterior Cruciate Ligament (ACL) Tear, run by University of Toronto Orthopaedic Sports Medicine at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Tear
- What is being tested?
- mobile app and conventional in-person
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Women's College Hospital
Toronto, Ontario, M5S1B1
James Higgins, MD, jhiggins@qmed.ca
Jennie Gillis, 6474053848, j.gillis@utosm.com
About this study
Official title: Conventional Follow-up Versus Mobile App Home Monitoring For Post-Operative Anterior Cruciate Ligament (ACL) Reconstruction Patients: A Randomized Controlled Trial
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
- Being tested
- mobile app, conventional in-person
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile appDevice
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-personOther
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.
| Study group | Role | What they receive |
|---|---|---|
| mobile app | Active comparator | Not described Receives: Device: mobile app |
| in-person | Active comparator | Not described Receives: Other: conventional in-person |
What is being measured
The primary outcome is the main question the study is designed to answer.
Required physician visits
Total number of physician visits (including specialist, family physician, and ER) related to surgery
Measured: 6 weeks post surgery
Secondary outcomes (1)
Health care phone calls
Total number of health care telephone calls and emails (including specialist, family physician and ER)
Measured: 6 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament (ACL) TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto Orthopaedic Sports Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942940
- Sponsor's protocol ID
- MobileApp
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2016
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Follow-up Versus Mobile App Home Monitoring For Post-Operative Anterior Cruciate Ligament (ACL) Reconstruction Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02942940
- Acronym / sponsor ID
- MobileApp
- Conditions
- Anterior Cruciate Ligament (ACL) Tear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Toronto Orthopaedic Sports MedicineUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mobile app | Active comparator | Device: mobile app |
| in-person | Active comparator | Other: conventional in-person |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- Patients who are smokers, as they carry increased rates of complications.
- Patients must not:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile appThe 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). | Device | mobile app |
| conventional in-personPatients 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. | Other | in-person |
Primary outcome
Required physician visits
Time frame: 6 weeks post surgery
Total number of physician visits (including specialist, family physician, and ER) related to surgery
1 secondary outcome
Health care phone calls
Time frame: 6 weeks post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile app and conventional in-person in people with Anterior Cruciate Ligament (ACL) Tear, run by University of Toronto Orthopaedic Sports Medicine at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Required physician visits (time frame: 6 weeks post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.