Prospective Comparative Multicenter Study of the Care Pathway After Shoulder Surgery

Clinique Victor Hugo

Status: Enrolling

Conditions: Shoulder Injury

Treatments: Procedure: Liberal follow-up; Procedure: Vivalto Dom follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT06808269

2024-28-CVH

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

210 participants in 2 patient groups

structured follow-up after surgery

Experimental group

Treatment:

Procedure: Vivalto Dom follow-up

liberal follow-up after surgery

Active Comparator group

Treatment:

Procedure: Liberal follow-up