Distal Radius Fracture, Distal Radius Fracture Fixation
Conditions
Keywords
distal radius fracture, postoperative follow-up, remote monitoring, virtual care, orthopaedic surgery
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.
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
BEHAVIORALRemote Monitoring Follow-Up
Participants will complete postoperative assessments through a secure, HIPAA-compliant digital health platform.
BEHAVIORALStandard In-Person Follow-Up
Participants will attend routine in-person postoperative clinic visits.
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomly assigned to one of two distinct groups and each group receives its respective intervention throughout the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Upper Extremity Score | 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
| Measure | Time frame | Description |
|---|---|---|
| PROMIS-29 Score | 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. |
| Ambulatory Patient Experience Score | 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 |
| Grip Strength | Baseline and 6 months | Grip strength will be measured using a standardized, FDA-cleared hand dynamometer in kilograms |
| Wrist Range of Motion | 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. |
| Complication Rate | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel A. London, MD
University of Missouri-Columbia
Outcome results
None listed