Prospective Comparative Multicenter Study of the Care Pathway After Shoulder Surgery

Overview

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.

Interventions

• 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 c
• 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 o

Primary outcome measures

• Pain intensity (VAS) [Time frame: 3 days, 6 weeks, 3 months and 6 months after surgery]

Secondary outcome measures (2)

• Patient comfort (Likert scale) [Time frame: 3 days, 6 weeks, 3 months and 6 months after surgery]
• Postoperative complications [Time frame: 3 days, 6 weeks, 3 months and 6 months after surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 2 centers

• Clinique Victor Hugo — Paris
• Centre hospitalier privé Saint-Grégoire — Saint-Grégoire

Identifiers

NCT: NCT06808269 · 2024-28-CVH

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗