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NCT Number: NCT06808269

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Victor Hugo, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain intensity (VAS)

    Time frame: 3 days, 6 weeks, 3 months and 6 months after surgery

    Pain will be measured using VAS (visual analog scale), from 0 ("no pain") to 10 (maximal pain)

Secondary outcomes

  1. Patient comfort (Likert scale)

    Time frame: 3 days, 6 weeks, 3 months and 6 months after surgery

    Patient comfort will be evaluated using a Likert scale for 6 questions. Scale is from 1 (total discomfort) to 5 (total comfort)

  2. Postoperative complications

    Time frame: 3 days, 6 weeks, 3 months and 6 months after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe Collin, MD

CONTACT

[email protected]

+33 6 08 91 47 47

Sponsors and collaborators

Lead sponsor

Clinique Victor Hugo

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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