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Enrolling by invitation NCT07219979

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

No phase Interventional Distal Radius Fracture Distal Radius Fracture Fixation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remote Monitoring Follow-Up, Standard In-Person Follow-Up.
Who it may be relevant to
Registry conditions: Distal Radius Fracture, Distal Radius Fracture Fixation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Behavioral Remote Monitoring Follow-Up
    Participants will complete postoperative assessments through a secure, HIPAA-compliant digital health platform.
  • Behavioral Standard In-Person Follow-Up
    Participants will attend routine in-person postoperative clinic visits.

Primary outcome measures

  • PROMIS Upper Extremity Score [Time frame: Baseline and 6 months]
Secondary outcome measures (5)
  • PROMIS-29 Score [Time frame: Baseline and 6 months]
  • Ambulatory Patient Experience Score [Time frame: Baseline and 6 months]
  • Grip Strength [Time frame: Baseline and 6 months]
  • Wrist Range of Motion [Time frame: Baseline to 6 months]
  • Complication Rate [Time frame: From enrollment to the end of treatment at 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Missouri - Columbia — Columbia

Identifiers

NCT: NCT07219979 · 2127568

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗