Rotator Cuff InjuriesOFUENCT04359160
Comparison of Follow-up by Mobile App or Paper Questionnaire of Patients Undergoing Rotator Cuff Surgery
A study testing Orthense, Orthense, Digikare Inc. Blagnac, France and Questionnaire in people with Rotator Cuff Injuries, run by L'Institut de Recherche en Chirurgie Orthopédique et Sportive at 1 site in France.
Trial summary
This study evaluate if in an outpatient rotator cuff surgery, can the use of mobile app compared to conventional paper questionnaire improve follow-up care in the first 90-days following surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- Orthense, Orthense, Digikare Inc. Blagnac, France and Questionnaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2020to 30 Nov 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing rotator cuff surgery. They must be able to use a mobile-app, and have an email address and internet connexion.
Who cannot join
- Unable to read French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Follow-up by Mobile Application or Paper Questionnaire of Patients Undergoing Rotator Cuff Surgery: Monocentric, Prospective, Randomized Study
This study evaluate if in an outpatient rotator cuff surgery, can the use of mobile app compared to conventional paper questionnaire improve follow-up care in the first 90-days following surgery.
Read the detailed description
Rotator cuff surgery is a painful arthroscopic surgery. In outpatient surgery, the surgeons have to increase the security and surveillance after the surgery to reassure the patient and avoid complications.
Most patients receiving ambulatory rotator cuff surgery have high pain score, and management and aspects of the rehabilitation can be challenging. However, regular follow-up is still considered important in the early post-operative phase. In between the conventional appointment 6 weeks post op and 12 weeks post op, the surgeons have no status of the patient, and no markers to check if the postoperative care is evolving right.
Currently, the investigators are using a mobile application (Orthense by Digikare, Blagnac, France) to complement in-person postoperative follow-up care for patients.
- Conditions
- Rotator Cuff Injuries
- Being tested
- Orthense, Orthense, Digikare Inc. Blagnac, France, Questionnaire
- Keywords
- Mobile App, Rotator Cuff, Outpatient surgery, Follow-up
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthense, Orthense, Digikare Inc. Blagnac, FranceDevice
Mobile-app follow-up care, with questions and score
QuestionnaireOther
Paper questionnaire follow-up, with questions and score
| Study group | Role | What they receive |
|---|---|---|
| Mobile-app follow-up | Experimental | The mobile app follow-up group will receive an email, to connect into a secure website. They will answer to periodical questions about their condition. They will have a medical appointment at 6 weeks postoperative and 12 weeks postoperative. All of this information is submitted via the mobile application (Orthense, Digikare Inc. Blagnac, France).The surgeon will have an access to the answer of the patient in real time, and if the patient didn't answer. Receives: Device: Orthense, Orthense, Digikare Inc. Blagnac, France |
| Conventional follow-up | Active comparator | Patients in the conventional, questionnaire follow-up group will have the same periodical questions but on paper. They will have to stick personally with the schedule without any reminders. They will have a medical appointment at 6 weeks postoperative and 12 weeks postoperative where they have to bring the questionnaire. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return rate
The overall response rate to the questionnaires
Measured: 6 weeks postoperative
Secondary outcomes (3)
The quality of the responses
response rate inside the questionnaire
Measured: 6 weeks postoperative
Net Promoter Score (NPS)
whether or not the patient recommended the questionnaire used, a scale of 0 (not at all likely) to 10 (very likely)
Measured: 6 weeks postoperative
Overall patient satisfaction
whether or not the patient is satisfied of the questionnaire used, a scale of 0 (not at all) to 10 (very good)
Measured: 6 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 May 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff InjuriesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- L'Institut de Recherche en Chirurgie Orthopédique et Sportive
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Grimberg, MD, Study director, L'Institut de Recherche en Chirurgie Orthopédique et Sportive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359160
- Sponsor's protocol ID
- 2020 0016 J
- Acronym
- OFUE
- Status last verified
- Jan 2021
- First submitted
- 20 Apr 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gil JA, Durand WM, Johnson JP, Goodman AD, Owens BD, Daniels AH. Unanticipated Admission Following Outpatient Rotator Cuff Repair: An Analysis of 18,061 Cases. Orthopedics. 2018 May 1;41(3):164-168. doi: 10.3928/01477447-20180501-04. Epub 2018 May 9.
PubMed 29738599Calvo E, Torres MD, Morcillo D, Leal V. Rotator cuff repair is more painful than other arthroscopic shoulder procedures. Arch Orthop Trauma Surg. 2019 May;139(5):669-674. doi: 10.1007/s00402-018-3100-0. Epub 2018 Dec 17.
PubMed 30560289Kosinski LR, Gil JA, Durand WM, DeFroda SF, Owens BD, Daniels AH. 30-Day readmission following outpatient rotator cuff repair: an analysis of 18,061 cases. Phys Sportsmed. 2018 Nov;46(4):466-470. doi: 10.1080/00913847.2018.1502571. Epub 2018 Jul 27.
PubMed 30021075Higgins J, Semple J, Murnaghan L, Sharpe S, Theodoropoulos J. Mobile Web-Based Follow-up for Postoperative ACL Reconstruction: A Single-Center Experience. Orthop J Sports Med. 2017 Dec 22;5(12):2325967117745278. doi: 10.1177/2325967117745278. eCollection 2017 Dec.
PubMed 29318171Armstrong KA, Coyte PC, Brown M, Beber B, Semple JL. Effect of Home Monitoring via Mobile App on the Number of In-Person Visits Following Ambulatory Surgery: A Randomized Clinical Trial. JAMA Surg. 2017 Jul 1;152(7):622-627. doi: 10.1001/jamasurg.2017.0111.
PubMed 28329223Descamps J, Le Hanneur M, Bouche PA, Boukebous B, Duranthon LD, Grimberg J. Do web-based follow-up surveys have a better response rate than traditional paper-based questionnaires following outpatient arthroscopic rotator cuff repair? A randomized controlled trial. Orthop Traumatol Surg Res. 2023 Apr;109(2):103479. doi: 10.1016/j.otsr.2022.103479. Epub 2022 Nov 17.
PubMed 36403889
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Follow-up by Mobile Application or Paper Questionnaire of Patients Undergoing Rotator Cuff Surgery: Monocentric, Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT04359160
- Acronym / sponsor ID
- OFUE / 2020 0016 J
- Conditions
- Rotator Cuff Injuries
- Keywords
- Mobile App, Rotator Cuff, Outpatient surgery, Follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- L'Institut de Recherche en Chirurgie Orthopédique et SportiveUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 24 Apr 2020 (actual)
- 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.
This study evaluate if in an outpatient rotator cuff surgery, can the use of mobile app compared to conventional paper questionnaire improve follow-up care in the first 90-days following surgery.
Detailed description
Rotator cuff surgery is a painful arthroscopic surgery. In outpatient surgery, the surgeons have to increase the security and surveillance after the surgery to reassure the patient and avoid complications.
Most patients receiving ambulatory rotator cuff surgery have high pain score, and management and aspects of the rehabilitation can be challenging. However, regular follow-up is still considered important in the early post-operative phase. In between the conventional appointment 6 weeks post op and 12 weeks post op, the surgeons have no status of the patient, and no markers to check if the postoperative care is evolving right.
Currently, the investigators are using a mobile application (Orthense by Digikare, Blagnac, France) to complement in-person postoperative follow-up care for patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile-app follow-up | Experimental | Device: Orthense, Orthense, Digikare Inc. Blagnac, FranceThe mobile app follow-up group will receive an email, to connect into a secure website. They will answer to periodical questions about their condition. They will have a medical appointment at 6 weeks postoperative and 12 weeks postoperative. All of this information is submitted via the mobile application (Orthense, Digikare Inc. Blagnac, France).The surgeon will have an access to the answer of the patient in real time, and if the patient didn't answer. |
| Conventional follow-up | Active comparator | Other: QuestionnairePatients in the conventional, questionnaire follow-up group will have the same periodical questions but on paper. They will have to stick personally with the schedule without any reminders. They will have a medical appointment at 6 weeks postoperative and 12 weeks postoperative where they have to bring the questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing rotator cuff surgery. They must be able to use a mobile-app, and have an email address and internet connexion.
Key exclusion criteria (1 listed)
- Unable to read French
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 |
|---|---|---|
| Orthense, Orthense, Digikare Inc. Blagnac, FranceMobile-app follow-up care, with questions and score | Device | Mobile-app follow-up |
| QuestionnairePaper questionnaire follow-up, with questions and score | Other | Conventional follow-up |
Primary outcome
Return rate
Time frame: 6 weeks postoperative
The overall response rate to the questionnaires
3 secondary outcomes
The quality of the responses
Time frame: 6 weeks postoperative
Net Promoter Score (NPS)
Time frame: 6 weeks postoperative
Overall patient satisfaction
Time frame: 6 weeks postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Background: PubMed 29738599Gil JA, Durand WM, Johnson JP, Goodman AD, Owens BD, Daniels AH. Unanticipated Admission Following Outpatient Rotator Cuff Repair: An Analysis of 18,061 Cases. Orthopedics. 2018 May 1;41(3):164-168. doi: 10.3928/01477447-20180501-04. Epub 2018 May 9.
- Background: PubMed 30560289Calvo E, Torres MD, Morcillo D, Leal V. Rotator cuff repair is more painful than other arthroscopic shoulder procedures. Arch Orthop Trauma Surg. 2019 May;139(5):669-674. doi: 10.1007/s00402-018-3100-0. Epub 2018 Dec 17.
- Background: PubMed 30021075Kosinski LR, Gil JA, Durand WM, DeFroda SF, Owens BD, Daniels AH. 30-Day readmission following outpatient rotator cuff repair: an analysis of 18,061 cases. Phys Sportsmed. 2018 Nov;46(4):466-470. doi: 10.1080/00913847.2018.1502571. Epub 2018 Jul 27.
- Background: PubMed 29318171Higgins J, Semple J, Murnaghan L, Sharpe S, Theodoropoulos J. Mobile Web-Based Follow-up for Postoperative ACL Reconstruction: A Single-Center Experience. Orthop J Sports Med. 2017 Dec 22;5(12):2325967117745278. doi: 10.1177/2325967117745278. eCollection 2017 Dec.
- Background: PubMed 28329223Armstrong KA, Coyte PC, Brown M, Beber B, Semple JL. Effect of Home Monitoring via Mobile App on the Number of In-Person Visits Following Ambulatory Surgery: A Randomized Clinical Trial. JAMA Surg. 2017 Jul 1;152(7):622-627. doi: 10.1001/jamasurg.2017.0111.
- Derived from this study: PubMed 36403889Descamps J, Le Hanneur M, Bouche PA, Boukebous B, Duranthon LD, Grimberg J. Do web-based follow-up surveys have a better response rate than traditional paper-based questionnaires following outpatient arthroscopic rotator cuff repair? A randomized controlled trial. Orthop Traumatol Surg Res. 2023 Apr;109(2):103479. doi: 10.1016/j.otsr.2022.103479. Epub 2022 Nov 17.
- Individual participant dataSharing planned: No
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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.
Jean Grimberg, MD study director
L'Institut de Recherche en Chirurgie Orthopédique et Sportive
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthense, Orthense, Digikare Inc. Blagnac, France and Questionnaire in people with Rotator Cuff Injuries, run by L'Institut de Recherche en Chirurgie Orthopédique et Sportive at 1 site in France.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Jan 2021. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return rate (time frame: 6 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04359160, which also lists 6 linked publications.
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 14 Jan 2021.