Prospective Comparative Multicenter Study of the Care Pathway After Shoulder Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Injury
• Intervention / Treatment: Procedure: Vivalto Dom follow-up; Procedure: Liberal follow-up

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe Collin, MD; Phone Number: +33 6 08 91 47 47; Email: docphcollin@gmail.com

Study Locations

• France
  • Paris, France, 75116
    • Recruiting
    • Clinique Victor Hugo
    • Contact: Marion Mandon, PhD; Phone Number: +33678 27 76 72; Email: mmandon@vivalto-sante.com
  • Saint-Grégoire, France, 35760
    • Recruiting
    • Centre Hospitalier Prive Saint-Gregoire
    • Contact: Marion Mandon, PhD; Phone Number: +33678 27 76 72; Email: mmandon@vivalto-sante.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: structured follow-up after surgery	Procedure: 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.
Active Comparator: liberal follow-up after surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity (VAS)	Pain will be measured using VAS (visual analog scale), from 0 ("no pain") to 10 (maximal pain)	3 days, 6 weeks, 3 months and 6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient comfort (Likert scale)	Patient comfort will be evaluated using a Likert scale for 6 questions. Scale is from 1 (total discomfort) to 5 (total comfort)	3 days, 6 weeks, 3 months and 6 months after surgery
Postoperative complications		3 days, 6 weeks, 3 months and 6 months after surgery

Collaborators and Investigators

• Sponsor: Clinique Victor Hugo

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: pain; comfort; shoulder surgery
• Additional Relevant MeSH Terms: Neurologic Manifestations; Wounds and Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Shoulder Injuries; Pain
• Other Study ID Numbers: 2024-28-CVH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No