Automated AI Voice Calls for Postoperative Follow-up After Arthroscopic Shoulder Instability Surgery (FOLAI)

February 18, 2026 updated by: Institut de Chirurgie Reparatrice Locomoteur et Sports

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

310

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • ICR Clinique Kantys Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion:

  • Age ≥18 years
  • History of arthroscopic shoulder instability surgery
  • Minimum postoperative follow-up of 12 months
  • Valid telephone contact information

Exclusion:

  • Previous ipsilateral surgery
  • Non-consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CONTROL
No Pre-notification
Other: SMS Pre-notification
Participants received an SMS text message approximately 2 hours before the first automated outbound call.
Experimental: INTERVENTION
SMS Pre-notification
Procedure: No Pre-notification
Participants received no SMS prior to the first automated outbound call.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survey completion within the first attempt window (including inbound callbacks)
Time Frame: 1 week
Completion during or following the first outbound call, including patient-initiated inbound callbacks.
1 week
Call outcome distribution
Time Frame: 1 week
Classification of call outcomes using a prespecified taxonomy
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Chirurgie Reparatrice Locomoteur et Sports

Investigators

  • Study Chair: Christophe Trojani, MD,PhD, ICR-Nice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2026

Primary Completion (Actual)

February 6, 2026

Study Completion (Actual)

February 13, 2026

Study Registration Dates

First Submitted

July 15, 2021

First Submitted That Met QC Criteria

July 15, 2021

First Posted (Actual)

July 22, 2021

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-190920-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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