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Not Yet RecruitingNCT07219979

Evaluating the Effectiveness of Remote Monitoring for Post-Operative Management of Distal Radius Fractures

Evaluating the Effectiveness of Remote Monitoring for Post-Operative Management of Distal Radius Fractures: A Randomized Controlled Trial

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
160 (estimated)
Sponsor
University of Missouri-Columbia · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This randomized controlled trial evaluates whether remote monitoring can provide a safe and effective alternative to traditional in-person follow-up after surgical fixation of distal radius fractures. The study compares functional outcomes, patient satisfaction, and complication rates between patients who receive virtual follow-up care and those who attend standard in-person visits.

Detailed description

This single-center, randomized controlled trial investigates the feasibility, safety, and effectiveness of a virtual postoperative follow-up model for patients undergoing operative fixation of distal radius fractures. Following surgery, eligible adult patients will be randomized 1:1 to either (1) standard in-person follow-up or (2) remote monitoring. Participants in the remote arm will complete follow-up assessments through secure online surveys, including PROMIS Upper Extremity, PROMIS-29, APEX, and ICHOM questionnaires. Grip strength will be measured using a dynamometer, and wrist range of motion will be evaluated through patient-submitted videos analyzed by the research team. Patients in the in-person arm will undergo identical assessments during routine clinic visits. The trial is designed as a non-inferiority study powered to determine whether remote follow-up achieves comparable recovery outcomes to in-person care while potentially improving access, satisfaction, and efficiency. Safety monitoring will include review of all adverse events and complications, with predefined criteria for pausing or modifying the protocol if unexpected risks arise

Conditions

Interventions

TypeNameDescription
BEHAVIORALRemote Monitoring Follow-UpParticipants will complete postoperative assessments through a secure, HIPAA-compliant digital health platform.
BEHAVIORALStandard In-Person Follow-UpParticipants will attend routine in-person postoperative clinic visits.

Timeline

Start date
2026-03-01
Primary completion
2027-12-31
Completion
2027-12-31
First posted
2025-10-23
Last updated
2026-02-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07219979. Inclusion in this directory is not an endorsement.