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Completed

NCT Number: NCT04359160

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

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.

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Key information

Conditions

Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Jouvenet

Paris, 75016, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthense, Orthense, Digikare Inc. Blagnac, France

Device

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

Questionnaire

Other

Paper questionnaire follow-up, with questions and score

Primary outcomes

  1. Return rate

    Time frame: 6 weeks postoperative

    The overall response rate to the questionnaires

Secondary outcomes

  1. The quality of the responses

    Time frame: 6 weeks postoperative

    response rate inside the questionnaire

  2. Net Promoter Score (NPS)

    Time frame: 6 weeks postoperative

    whether or not the patient recommended the questionnaire used, a scale of 0 (not at all likely) to 10 (very likely)

  3. Overall patient satisfaction

    Time frame: 6 weeks postoperative

    whether or not the patient is satisfied of the questionnaire used, a scale of 0 (not at all) to 10 (very good)

Sponsors and collaborators

Lead sponsor

L'Institut de Recherche en Chirurgie Orthopédique et Sportive

Other

Registry information

Official study title

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

Acronym: OFUE

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2020
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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