Prospective Comparative Multicenter Study of the Care Pathway After Shoulder Surgery

NCT ID: NCT06808269

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-19
• Study Completion Date: 2026-08-31

Brief Summary

Post-operative management of shoulder surgery patients, particularly in terms of pain management and follow-up, can vary from one center to another, influencing clinical outcomes and patient satisfaction. The aim of this study is to compare two approaches to post-operative follow-up in two distinct centers: structured follow-up using the Vivalto-Dom protocol in Paris, and autonomous follow-up through contact with a nurse in Saint-Grégoire. The hypothesis is that these differences in the care pathway will affect pain management, comfort and patient satisfaction. By controlling for operative variability (a single surgeon operating in both centers), the study will identify the most effective follow-up practices for improving post-operative management, with the ultimate aim of optimizing quality of care and reducing post-operative complications.

Conditions

Shoulder Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

structured follow-up after surgery

Group Type: EXPERIMENTAL

Vivalto Dom follow-up

Intervention Type: PROCEDURE

During the pre-operative consultation, the patient receives a prescription for medication (analgesics and anti-inflammatories) for immediate post-operative pain relief. They also receive a "patient information booklet" (see appendix 6). On discharge from surgery, the patient returns home with Vivalto Dom in charge of nursing care and follow-up medication.

Vivalto Dom is a homecare structure whose mission is to coordinate the discharge of patients back home, and to ensure continuity of overall care (care and social aspects) between the hospital and the city.

liberal follow-up after surgery

Group Type: ACTIVE_COMPARATOR

Liberal follow-up

Intervention Type: PROCEDURE

The pre-operative and operative course (fasting rules, skin preparation, hospitalization, surgery) is the same as for all routine care patients. The patient is informed before surgery that he or she must make an appointment with a nurse for post-operative care at home; a prescription for medication (analgesics and anti-inflammatories) has been given by the anaesthetist for immediate analgesic treatment, and on discharge from hospital he or she receives another prescription from the surgeon for oral relay treatment.

Follow-up at home takes place over 3 days, with a private nurse visiting the patient's home every day.

During the follow-up, the nurse performs clinical monitoring of the following items: pulse, blood pressure, temperature, pain, bleeding, monitoring of the surgical wound, transit, nausea and vomiting. The patient is also guided through the medication protocol.

Interventions

Vivalto Dom follow-up

During the pre-operative consultation, the patient receives a prescription for medication (analgesics and anti-inflammatories) for immediate post-operative pain relief. They also receive a "patient information booklet" (see appendix 6). On discharge from surgery, the patient returns home with Vivalto Dom in charge of nursing care and follow-up medication.

Vivalto Dom is a homecare structure whose mission is to coordinate the discharge of patients back home, and to ensure continuity of overall care (care and social aspects) between the hospital and the city.

Intervention Type: PROCEDURE

Liberal follow-up

The pre-operative and operative course (fasting rules, skin preparation, hospitalization, surgery) is the same as for all routine care patients. The patient is informed before surgery that he or she must make an appointment with a nurse for post-operative care at home; a prescription for medication (analgesics and anti-inflammatories) has been given by the anaesthetist for immediate analgesic treatment, and on discharge from hospital he or she receives another prescription from the surgeon for oral relay treatment.

Follow-up at home takes place over 3 days, with a private nurse visiting the patient's home every day.

During the follow-up, the nurse performs clinical monitoring of the following items: pulse, blood pressure, temperature, pain, bleeding, monitoring of the surgical wound, transit, nausea and vomiting. The patient is also guided through the medication protocol.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient eligible for one of the following 4 types of surgery: Simple non-repair arthroscopic surgery (acromion, calcification), arthroscopic repair surgery (cuff, DAS, bankart), open surgery without prosthesis (ligamentoplasty, bone block), open surgery with prosthesis (inverted prosthesis, anatomic prosthesis, etc.).

Exclusion Criteria

• Patients with one or more communication disorders.
• Pregnant or breast-feeding patients
• Patients not covered by a social security scheme
• Refusal to participate in research
• Patients unable to understand or give informed consent
• Patients under guardianship, deprived of liberty or under court protection
• Patients with past or present drug addiction
• Patients with neuropathy
• Patients with cognitive disorders
• Patients with chronic illnesses or inflammatory pathologies leading to chronic pain.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinique Victor Hugo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Victor Hugo

Paris, , France

Site Status: RECRUITING

Centre hospitalier privé Saint-Grégoire

Saint-Grégoire, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Philippe Collin, MD

Role: CONTACT

docphcollin@gmail.com

+33 6 08 91 47 47

Facility Contacts

Marion Mandon, PhD

Role: primary

mmandon@vivalto-sante.com

+33678 27 76 72

Marion Mandon, PhD

Role: primary

mmandon@vivalto-sante.com

+33678 27 76 72

Other Identifiers

2024-28-CVH

Identifier Type: -

Identifier Source: org_study_id