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

Rotator Cuff Injuries Clinical Trial

— OFUE  

Official title:

Comparison of Follow-up by Mobile Application or Paper Questionnaire of Patients Undergoing Rotator Cuff Surgery: Monocentric, Prospective, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04359160
• Other study ID #: 2020 0016 J
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: January 2021
• Source: L'Institut de Recherche en Chirurgie Orthopédique et Sportive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries

Intervention

Device:
• Orthense, Orthense, Digikare Inc. Blagnac, France
Mobile-app follow-up care, with questions and score

Other:
• Questionnaire
Paper questionnaire follow-up, with questions and score

Locations

Country	Name	City	State
France	Clinique Jouvenet	Paris

Sponsors (1)

Lead Sponsor	Collaborator
L'Institut de Recherche en Chirurgie Orthopédique et Sportive

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return rate	The overall response rate to the questionnaires	6 weeks postoperative
Secondary	The quality of the responses	response rate inside the questionnaire	6 weeks postoperative
Secondary	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)	6 weeks postoperative
Secondary	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)	6 weeks postoperative