Clinical trial NCT04359160: Comparison of Follow-up by Mobile App or Paper Questionnaire of Patients Undergoing Rotator Cuff Surgery
Official title: Comparison of Follow-up by Mobile Application or Paper Questionnaire of Patients Undergoing Rotator Cuff Surgery: Monocentric, Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injuries
Keywords: Mobile App
Rotator Cuff
Outpatient surgery
Follow-up
Lead sponsor: L'Institut de Recherche en Chirurgie Orthopédique et Sportive
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Return rate
timeFrame: 6 weeks postoperative
Secondary outcomes:
measure: The quality of the responses
timeFrame: 6 weeks postoperative
measure: Net Promoter Score (NPS)
timeFrame: 6 weeks postoperative
measure: Overall patient satisfaction
timeFrame: 6 weeks postoperative
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique Jouvenet
Study officials:
affiliation: L'Institut de Recherche en Chirurgie Orthopédique et Sportive
name: Jean Grimberg, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.