Distal Radius FractureNCT07219979
Evaluating the Effectiveness of Remote Monitoring for Post-Operative Management of Distal Radius Fractures
A study testing Remote Monitoring Follow-Up and Standard In-Person Follow-Up in people with Distal Radius Fracture and Distal Radius Fracture Fixation, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture, Distal Radius Fracture Fixation
- What is being tested?
- Remote Monitoring Follow-Up and Standard In-Person Follow-Up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years old or older
- Operatively treated distal radius fracture
- Access to smartphone/computer.
Who cannot join
- Prior significant wrist/hand injury
- lack of internet access
- Surgeon determination that injury is not suitable for the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Missouri - Columbia
Columbia, Missouri, 65212
About this study
Official title: Evaluating the Effectiveness of Remote Monitoring for Post-Operative Management of Distal Radius Fractures: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Remote Monitoring Follow-Up, Standard In-Person Follow-Up
- Keywords
- distal radius fracture, postoperative follow-up, remote monitoring, virtual care, orthopaedic surgery
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Monitoring Follow-UpBehavioural
Participants will complete postoperative assessments through a secure, HIPAA-compliant digital health platform.
Standard In-Person Follow-UpBehavioural
Participants will attend routine in-person postoperative clinic visits.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Standard In-Person Follow-Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 6 months
Secondary outcomes (5)
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.
Measured: 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
Measured: Baseline and 6 months
Grip Strength
Grip strength will be measured using a standardized, FDA-cleared hand dynamometer in kilograms
Measured: 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.
Measured: 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
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2025
- Study start8 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two distinct groups and each group receives its respective intervention throughout the study.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel London, University of Missouri-Columbia
- Investigators
- Daniel A. London, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219979
- Sponsor's protocol ID
- 2127568
- Status last verified
- Apr 2026
- First submitted
- 20 Oct 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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