Comparison of Follow-up by Mobile App or Paper Questionnaire of Patients Undergoing Rotator Cuff Surgery

NCT ID: NCT04359160

Last Updated: 2021-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-11-30

Brief Summary

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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

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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

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Rotator Cuff Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Mobile-app follow-up

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.

Group Type EXPERIMENTAL

Orthense, Orthense, Digikare Inc. Blagnac, France

Intervention Type DEVICE

Mobile-app follow-up care, with questions and score

Conventional follow-up

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.

Group Type ACTIVE_COMPARATOR

Questionnaire

Intervention Type OTHER

Paper questionnaire follow-up, with questions and score

Interventions

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Orthense, Orthense, Digikare Inc. Blagnac, France

Mobile-app follow-up care, with questions and score

Intervention Type DEVICE

Questionnaire

Paper questionnaire follow-up, with questions and score

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing rotator cuff surgery. They must be able to use a mobile-app, and have an email address and internet connexion.

Exclusion Criteria

* Unable to read French
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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L'Institut de Recherche en Chirurgie Orthopédique et Sportive

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Grimberg, MD

Role: STUDY_DIRECTOR

L'Institut de Recherche en Chirurgie Orthopédique et Sportive

Locations

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Clinique Jouvenet

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 29738599 (View on PubMed)

Calvo 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.

Reference Type BACKGROUND
PMID: 30560289 (View on PubMed)

Kosinski 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.

Reference Type BACKGROUND
PMID: 30021075 (View on PubMed)

Higgins 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.

Reference Type BACKGROUND
PMID: 29318171 (View on PubMed)

Armstrong 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.

Reference Type BACKGROUND
PMID: 28329223 (View on PubMed)

Descamps 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.

Reference Type DERIVED
PMID: 36403889 (View on PubMed)

Other Identifiers

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2020 0016 J

Identifier Type: -

Identifier Source: org_study_id

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