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

NCT04972331 | Completed DMC

• 1 other identifier: 2025-190920-01
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Shoulder Instability

Outcome Measures

Primary Outcomes (1)

• Survey completion during the first automated outbound call

  Proportion of participants who completed the automated survey during the first outbound call attempt.

  1 week

Secondary Outcomes (2)

• Survey completion within the first attempt window (including inbound callbacks)

  1 week

• Call outcome distribution

  1 week

Study Arms (2)

CONTROL

ACTIVE COMPARATOR

No Pre-notification

Other: SMS Pre-notification

INTERVENTION

EXPERIMENTAL

SMS Pre-notification

Procedure: No Pre-notification

Interventions

SMS Pre-notification OTHER

Participants received an SMS text message approximately 2 hours before the first automated outbound call.

CONTROL

No Pre-notification PROCEDURE

Participants received no SMS prior to the first automated outbound call.

INTERVENTION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous ipsilateral surgery
• Non-consent

Sponsors & Collaborators

• Institut de Chirurgie Reparatrice Locomoteur et Sports: lead

Study Sites (1)

ICR Clinique Kantys Centre

Nice, 06000, France

Location

Related Publications (3)

• 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.

  PMID: 41548028 BACKGROUND

• Dal 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.

  PMID: 26919558 BACKGROUND

• Nayak 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.

  PMID: 38039007 BACKGROUND

Study Officials

• Christophe Trojani, MD,PhD

  ICR-Nice

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 22, 2021
• Study Start: January 27, 2026
• Primary Completion: February 6, 2026
• Study Completion: February 13, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)