Comparing post-op care pathways after shoulder surgery
Prospective Comparative Multicenter Study of the Care Pathway After Shoulder Surgery
NA · Clinique Victor Hugo · NCT06808269
This project will test whether a structured Vivalto-Dom follow-up or an autonomous nurse-contact follow-up leads to better pain control, comfort, and satisfaction for patients after shoulder surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinique Victor Hugo (other) |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT06808269 on ClinicalTrials.gov |
What this trial studies
This prospective multicenter comparative interventional study compares two postoperative follow-up approaches for shoulder surgery patients: the structured Vivalto-Dom protocol at Clinique Victor Hugo in Paris and an autonomous nurse-contact pathway at Centre hospitalier privé Saint-Grégoire. A single surgeon will operate at both centers to limit variability in the surgical procedure. The trial will measure postoperative pain management, patient comfort, and satisfaction using each center's follow-up protocol. Results aim to identify which care pathway improves recovery and reduces postoperative complications.
Who should consider this trial
Good fit: Adults scheduled for one of the specified shoulder surgeries (simple arthroscopy, arthroscopic repair, open surgery with or without prosthesis) who can understand and give informed consent and are covered by social security are ideal candidates.
Not a fit: Patients with communication or cognitive disorders, neuropathy, chronic inflammatory pain conditions, active addiction, pregnancy or breastfeeding, lack of social security coverage, or inability to consent are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the preferred follow-up approach could improve pain control, increase patient comfort and satisfaction, and lower the risk of postoperative issues.
How similar studies have performed: Previous orthopedic studies of structured post-op follow-up and remote monitoring have shown improvements in satisfaction and pain control, but direct comparisons between Vivalto-Dom and nurse-led autonomous follow-up are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Paris and 1 other locations
- Clinique Victor Hugo — Paris, France (RECRUITING)
- Centre hospitalier privé Saint-Grégoire — Saint-Grégoire, France (RECRUITING)
Study contacts
- Study coordinator: Philippe Collin, MD
- Email: docphcollin@gmail.com
- Phone: +33 6 08 91 47 47
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Shoulder Injury, shoulder surgery, pain, comfort