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Enrolling by Invitation

NCT Number: NCT07219979

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

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.

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Key information

Conditions

Distal Radius Fracture Arm Injuries Distal Radius Fracture Fixation Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri - Columbia

Columbia, Missouri, 65212, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote Monitoring Follow-Up

Behavioral

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

Standard In-Person Follow-Up

Behavioral

Participants will attend routine in-person postoperative clinic visits.

Primary outcomes

  1. PROMIS Upper Extremity Score

    Time frame: Baseline and 6 months

    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

Secondary outcomes

  1. PROMIS-29 Score

    Time frame: Baseline and 6 months

    The PROMIS-29 Profile assesses global physical, mental, and social health across domains including pain interference, fatigue, physical function, depression, anxiety, and sleep. Scores range from 0-100, with higher scores reflecting better health status for positively scored domains.

  2. Ambulatory Patient Experience Score

    Time frame: Baseline and 6 months

    The Ambulatory Patient Experience (APEX) Questionnaire measures patient satisfaction and experience with outpatient care using validated multi-item scales. Scores are transformed to a 0-100 scale, with higher scores indicating greater satisfaction

  3. Grip Strength

    Time frame: Baseline and 6 months

    Grip strength will be measured using a standardized, FDA-cleared hand dynamometer in kilograms

  4. Wrist Range of Motion

    Time frame: Baseline to 6 months

    Wrist flexion, extension, pronation, and supination will be measured using standardized photogoniometry methods. For remote participants, motion will be assessed via patient-submitted videos analyzed by study staff.

  5. Complication Rate

    Time frame: From enrollment to the end of treatment at 6 months

    Complications including infection, hardware failure, malunion, nonunion, and stiffness will be recorded for all participants through chart review and patient report. Rates will be compared between the remote monitoring and in-person groups to ensure patient safety and equivalence of outcomes. Complications will be measured as a percentage of patients who experience the complication

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 23, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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