Shoulder InjuryChirépauleNCT06808269
Prospective Comparative Multicenter Study of the Care Pathway After Shoulder Surgery
A study testing Vivalto Dom follow-up and Liberal follow-up in people with Shoulder Injury, run by Clinique Victor Hugo at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Injury
- What is being tested?
- Vivalto Dom follow-up and Liberal follow-up
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesFrance
- Study dates
- 19 May 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.).
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Clinique Victor Hugo
Paris, 75116
Marion Mandon, PhD, +33678 27 76 72, mmandon@vivalto-sante.com
- Recruiting
Centre hospitalier privé Saint-Grégoire
Saint-Grégoire, 35760
Marion Mandon, PhD, +33678 27 76 72, mmandon@vivalto-sante.com
About this study
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
- Being tested
- Vivalto Dom follow-up, Liberal follow-up
- Keywords
- shoulder surgery, pain, comfort
- Medical subject headings
- Shoulder Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivalto Dom follow-upProcedure or surgery
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-upProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| structured follow-up after surgery | Experimental | Not described Receives: Procedure: Vivalto Dom follow-up |
| liberal follow-up after surgery | Active comparator | Not described Receives: Procedure: Liberal follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (VAS)
Pain will be measured using VAS (visual analog scale), from 0 ("no pain") to 10 (maximal pain)
Measured: 3 days, 6 weeks, 3 months and 6 months after surgery
Secondary outcomes (2)
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)
Measured: 3 days, 6 weeks, 3 months and 6 months after surgery
Postoperative complications
Measured: 3 days, 6 weeks, 3 months and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start19 May 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Victor Hugo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808269
- Sponsor's protocol ID
- 2024-28-CVH
- Other IDs
- 2024-A02076-41
- Acronym
- Chirépaule
- Status last verified
- Sep 2026
- First submitted
- 28 Jan 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Multicenter Study of the Care Pathway After Shoulder Surgery
- ClinicalTrials.gov ID
- NCT06808269
- Acronym / sponsor ID
- Chirépaule / 2024-28-CVH
- Conditions
- Shoulder Injury
- Keywords
- shoulder surgery, pain, comfort
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Clinique Victor HugoUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| structured follow-up after surgery | Experimental | Procedure: Vivalto Dom follow-up |
| liberal follow-up after surgery | Active comparator | Procedure: Liberal follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.).
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivalto Dom follow-upDuring 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. | Procedure or surgery | structured follow-up after surgery |
| Liberal follow-upThe 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. | Procedure or surgery | liberal follow-up after surgery |
Primary outcome
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)
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivalto Dom follow-up and Liberal follow-up in people with Shoulder Injury, run by Clinique Victor Hugo at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Collin, MD (+33 6 08 91 47 47, docphcollin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (VAS) (time frame: 3 days, 6 weeks, 3 months and 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.