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

NCT ID: NCT07219979

Last Updated: 2025-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-12-31

Brief Summary

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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

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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

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Distal Radius Fracture Distal Radius Fracture Fixation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomly assigned to one of two distinct groups and each group receives its respective intervention throughout the study.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Remote Monitoring Follow-Up

Participants in this arm will complete postoperative follow-up through a digital health platform. At 6 weeks, 3 months, and 6 months after surgery, they will complete electronic PROMs , measure grip strength using a dynamometer, and submit short wrist range-of-motion videos for remote evaluation. Participants will be instructed to contact the clinical team if any concerns arise.

Group Type EXPERIMENTAL

Remote Monitoring Follow-Up

Intervention Type BEHAVIORAL

Participants will complete postoperative assessments through a secure, HIPAA-compliant digital health platform.

In-Person Standard Follow-Up

Participants in this arm will attend routine postoperative clinic visits at 6 weeks, 3 months, and 6 months, following standard of care for distal radius fracture management. At each visit, PROMs will be completed, and grip strength and range of motion will be measured by the clinical team. Care decisions and management will follow institutional standards for in-person postoperative evaluation

Group Type ACTIVE_COMPARATOR

Standard In-Person Follow-Up

Intervention Type BEHAVIORAL

Participants will attend routine in-person postoperative clinic visits.

Interventions

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Remote Monitoring Follow-Up

Participants will complete postoperative assessments through a secure, HIPAA-compliant digital health platform.

Intervention Type BEHAVIORAL

Standard In-Person Follow-Up

Participants will attend routine in-person postoperative clinic visits.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults 18 years old or older
* Operatively treated distal radius fracture
* Access to smartphone/computer.

Exclusion Criteria

* Prior significant wrist/hand injury
* lack of internet access
* Surgeon determination that injury is not suitable for the trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Daniel London

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel A. London, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

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University of Missouri - Columbia

Columbia, Missouri, United States

Site Status

Countries

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United States

Central Contacts

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Bryce F. Rizvanović, BS, CCRP

Role: CONTACT

5738841248

Facility Contacts

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Bryce F. Rizvanović, BS, CCRP

Role: primary

5738841248

Vicki L. Jones, MEd, CCRP

Role: backup

Other Identifiers

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2127568

Identifier Type: -

Identifier Source: org_study_id

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