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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Participants will complete postoperative assessments through a secure, HIPAA-compliant digital health platform.
Participants will attend routine in-person postoperative clinic visits.
University of Missouri - Columbia
Columbia, Missouri, United States
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
Time frame: Baseline and 6 months
PROMIS-29 Score
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.
Time frame: Baseline and 6 months
Ambulatory Patient Experience Score
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
Time frame: Baseline and 6 months
Grip Strength
Grip strength will be measured using a standardized, FDA-cleared hand dynamometer in kilograms
Time frame: Baseline and 6 months
Wrist Range of Motion
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.
Time frame: Baseline to 6 months
Complication Rate
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
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Time frame: From enrollment to the end of treatment at 6 months