Prospective Comparative Multicenter Study of the Care Pathway After Shoulder Surgery

NCT06808269 | Recruiting

• 1 other identifier: 2024-28-CVH
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 2

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

Keywords

shoulder surgery; pain; comfort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient comfort (Likert scale)

  3 days, 6 weeks, 3 months and 6 months after surgery

• Postoperative complications

  3 days, 6 weeks, 3 months and 6 months after surgery

Study Arms (2)

structured follow-up after surgery

EXPERIMENTAL

Procedure: Vivalto Dom follow-up

liberal follow-up after surgery

ACTIVE COMPARATOR

Procedure: Liberal follow-up

Interventions

Liberal follow-up 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.

liberal follow-up after surgery

Vivalto Dom follow-up 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.

structured follow-up after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinique Victor Hugo: lead

Study Sites (2)

Clinique Victor Hugo

Paris, 75116, France

RECRUITING

Centre hospitalier privé Saint-Grégoire

Saint-Grégoire, 35760, France

RECRUITING

MeSH Terms

Conditions

Shoulder Injuries; Pain

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Philippe Collin, MD

CONTACT

+33 6 08 91 47 47; docphcollin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 5, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)