Shoulder InstabilityFOLAINCT04972331
Automated AI Voice Calls for Postoperative Follow-up After Arthroscopic Shoulder Instability Surgery
A study testing SMS Pre-notification and No Pre-notification in people with Shoulder Instability, run by Institut de Chirurgie Reparatrice Locomoteur et Sports at 1 site in France.
Trial summary
This prospective, single-center randomized clinical trial evaluates the technical efficacy, accuracy, and operational performance of an automated conversational artificial intelligence (AI) voice agent for postoperative follow-up after arthroscopic shoulder instability surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Instability
- What is being tested?
- SMS Pre-notification and No Pre-notification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2026to 13 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age ≥18 years
- History of arthroscopic shoulder instability surgery
- Minimum postoperative follow-up of 12 months
- Valid telephone contact information
Who cannot join
- Previous ipsilateral surgery
- Non-consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Automated AI Voice Calls for Postoperative Orthopedic Follow-up: A Randomized Trial of SMS Pre-notification and Blinded Validation of PROM Capture.
This prospective, single-center randomized clinical trial evaluates the technical efficacy, accuracy, and operational performance of an automated conversational artificial intelligence (AI) voice agent for postoperative follow-up after arthroscopic shoulder instability surgery. The study examines whether SMS pre-notification improves survey completion during the first automated outbound call and assesses the accuracy of AI-captured patient-reported outcomes compared with blinded human review.
Read the detailed description
Participants who underwent arthroscopic shoulder instability surgery at least one year prior were contacted using an automated AI voice agent to collect standardized postoperative outcomes. Patients were randomized 1:1 to receive an SMS pre-notification prior to the first automated call or no pre-notification. The AI agent conducted structured interviews and classified call outcomes using a prespecified taxonomy. A hybrid protocol combining automated outbound calls, inbound callbacks, and targeted human follow-up was implemented to maximize data capture while minimizing resource use. All completed calls were independently audited by a blinded human reviewer to assess agreement with AI-extracted outcomes.
- Conditions
- Shoulder Instability
- Being tested
- SMS Pre-notification, No Pre-notification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS Pre-notificationOther
Participants received an SMS text message approximately 2 hours before the first automated outbound call.
No Pre-notificationProcedure or surgery
Participants received no SMS prior to the first automated outbound call.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | Active comparator | No Pre-notification Receives: Other: SMS Pre-notification |
| INTERVENTION | Experimental | SMS Pre-notification Receives: Procedure: No Pre-notification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey completion during the first automated outbound call
Proportion of participants who completed the automated survey during the first outbound call attempt.
Measured: 1 week
Secondary outcomes (2)
Survey completion within the first attempt window (including inbound callbacks)
Completion during or following the first outbound call, including patient-initiated inbound callbacks.
Measured: 1 week
Call outcome distribution
Classification of call outcomes using a prespecified taxonomy
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start27 Jan 2026
- Primary completion6 Feb 2026
- Study completion13 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Shoulder InstabilityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Chirurgie Reparatrice Locomoteur et Sports
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Christophe Trojani, MD,PhD, Study chair, ICR-Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972331
- Sponsor's protocol ID
- 2025-190920-01
- Other IDs
- 2025
- Acronym
- FOLAI
- Status last verified
- Feb 2026
- First submitted
- 15 Jul 2021
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li J, Zhang Y, Zhang Z, Zhou Y, Gao Y, Li X, Fan S. A randomized controlled trial of a WeChat-based artificial intelligence agent for postoperative care in orthopedic patients. NPJ Digit Med. 2026 Jan 17;9(1):105. doi: 10.1038/s41746-025-02269-8.
PubMed 41548028Dal Grande E, Chittleborough CR, Campostrini S, Dollard M, Taylor AW. Pre-Survey Text Messages (SMS) Improve Participation Rate in an Australian Mobile Telephone Survey: An Experimental Study. PLoS One. 2016 Feb 26;11(2):e0150231. doi: 10.1371/journal.pone.0150231. eCollection 2016.
PubMed 26919558Nayak A, Vakili S, Nayak K, Nikolov M, Chiu M, Sosseinheimer P, Talamantes S, Testa S, Palanisamy S, Giri V, Schulman K. Use of Voice-Based Conversational Artificial Intelligence for Basal Insulin Prescription Management Among Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2340232. doi: 10.1001/jamanetworkopen.2023.40232.
PubMed 38039007
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated AI Voice Calls for Postoperative Orthopedic Follow-up: A Randomized Trial of SMS Pre-notification and Blinded Validation of PROM Capture.
- ClinicalTrials.gov ID
- NCT04972331
- Acronym / sponsor ID
- FOLAI / 2025-190920-01
- Conditions
- Shoulder Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Institut de Chirurgie Reparatrice Locomoteur et SportsResearch network
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 6 Feb 2026 (actual)
- Study completion
- 13 Feb 2026 (actual)
- First posted
- 22 Jul 2021 (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.
This prospective, single-center randomized clinical trial evaluates the technical efficacy, accuracy, and operational performance of an automated conversational artificial intelligence (AI) voice agent for postoperative follow-up after arthroscopic shoulder instability surgery. The study examines whether SMS pre-notification improves survey completion during the first automated outbound call and assesses the accuracy of AI-captured patient-reported outcomes compared with blinded human review.
Detailed description
Participants who underwent arthroscopic shoulder instability surgery at least one year prior were contacted using an automated AI voice agent to collect standardized postoperative outcomes. Patients were randomized 1:1 to receive an SMS pre-notification prior to the first automated call or no pre-notification. The AI agent conducted structured interviews and classified call outcomes using a prespecified taxonomy. A hybrid protocol combining automated outbound calls, inbound callbacks, and targeted human follow-up was implemented to maximize data capture while minimizing resource use. All completed calls were independently audited by a blinded human reviewer to assess agreement with AI-extracted outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL | Active comparator | Other: SMS Pre-notificationNo Pre-notification |
| INTERVENTION | Experimental | Procedure: No Pre-notificationSMS Pre-notification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- History of arthroscopic shoulder instability surgery
- Minimum postoperative follow-up of 12 months
- Valid telephone contact information
Key exclusion criteria (2 listed)
- Previous ipsilateral surgery
- Non-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 |
|---|---|---|
| SMS Pre-notificationParticipants received an SMS text message approximately 2 hours before the first automated outbound call. | Other | CONTROL |
| No Pre-notificationParticipants received no SMS prior to the first automated outbound call. | Procedure or surgery | INTERVENTION |
Primary outcome
Survey completion during the first automated outbound call
Time frame: 1 week
Proportion of participants who completed the automated survey during the first outbound call attempt.
2 secondary outcomes
Survey completion within the first attempt window (including inbound callbacks)
Time frame: 1 week
Call outcome distribution
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Background: PubMed 41548028Li J, Zhang Y, Zhang Z, Zhou Y, Gao Y, Li X, Fan S. A randomized controlled trial of a WeChat-based artificial intelligence agent for postoperative care in orthopedic patients. NPJ Digit Med. 2026 Jan 17;9(1):105. doi: 10.1038/s41746-025-02269-8.
- Background: PubMed 26919558Dal Grande E, Chittleborough CR, Campostrini S, Dollard M, Taylor AW. Pre-Survey Text Messages (SMS) Improve Participation Rate in an Australian Mobile Telephone Survey: An Experimental Study. PLoS One. 2016 Feb 26;11(2):e0150231. doi: 10.1371/journal.pone.0150231. eCollection 2016.
- Background: PubMed 38039007Nayak A, Vakili S, Nayak K, Nikolov M, Chiu M, Sosseinheimer P, Talamantes S, Testa S, Palanisamy S, Giri V, Schulman K. Use of Voice-Based Conversational Artificial Intelligence for Basal Insulin Prescription Management Among Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2340232. doi: 10.1001/jamanetworkopen.2023.40232.
- 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. This study is not recruiting at the moment.
Christophe Trojani, MD,PhD study chair
ICR-Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS Pre-notification and No Pre-notification in people with Shoulder Instability, run by Institut de Chirurgie Reparatrice Locomoteur et Sports at 1 site 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survey completion during the first automated outbound call (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04972331, which also lists 3 linked publications.
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 20 Feb 2026.