NCT07219979

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

October 20, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

April 8, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

October 20, 2025

Last Update Submit

April 22, 2026

Conditions

Keywords

distal radius fracturepostoperative follow-upremote monitoringvirtual careorthopaedic surgery

Outcome Measures

Primary Outcomes (1)

  • PROMIS Upper Extremity Score

    The PROMIS Upper Extremity (UE) Computer Adaptive Test assesses upper limb function, including strength, dexterity, and ability to perform daily activities. Scores range from 0 to 100, with higher scores indicating better function. The primary analysis will compare mean change in PROMIS UE scores from baseline (2 weeks post-operation) to 6 months post-operation

    Baseline and 6 months

Secondary Outcomes (5)

  • PROMIS-29 Score

    Baseline and 6 months

  • Ambulatory Patient Experience Score

    Baseline and 6 months

  • Grip Strength

    Baseline and 6 months

  • Wrist Range of Motion

    Baseline to 6 months

  • Complication Rate

    From enrollment to the end of treatment at 6 months

Study Arms (2)

Remote Monitoring Follow-Up

EXPERIMENTAL

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.

Behavioral: Remote Monitoring Follow-Up

In-Person Standard Follow-Up

ACTIVE COMPARATOR

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

Behavioral: Standard In-Person Follow-Up

Interventions

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

Remote Monitoring Follow-Up

Participants will attend routine in-person postoperative clinic visits.

In-Person Standard Follow-Up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Prior significant wrist/hand injury
  • lack of internet access
  • Surgeon determination that injury is not suitable for the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri - Columbia

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Daniel A. London, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to one of two distinct groups and each group receives its respective intervention throughout the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 20, 2025

First Posted

October 23, 2025

Study Start

April 8, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

This study involves clinical and patient-reported data collected within a single institution (University of Missouri) under IRB-approved protocols that limit data use to authorized study personnel. While aggregate results will be disseminated through peer-reviewed publications and presentations, individual-level data will not be shared externally to protect participant privacy and comply with institutional data governance policies

Locations