Evaluating the Effectiveness of Remote Monitoring for Post-Operative Management of Distal Radius Fractures: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- PROMIS Upper Extremity Score
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years old or older
- •Operatively treated distal radius fracture
- •Access to smartphone/computer.
排除标准
- •Prior significant wrist/hand injury
- •lack of internet access
- •Surgeon determination that injury is not suitable for the trial
研究组 & 干预措施
Remote Monitoring Follow-Up
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.
干预措施: Remote Monitoring Follow-Up (Behavioral)
In-Person Standard Follow-Up
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
干预措施: Standard In-Person Follow-Up (Behavioral)
结局指标
主要结局
PROMIS Upper Extremity Score
时间窗: 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
次要结局
- PROMIS-29 Score(Baseline and 6 months)
- Ambulatory Patient Experience Score(Baseline and 6 months)
- Grip Strength(Baseline and 6 months)
- Wrist Range of Motion(Baseline to 6 months)
- Complication Rate(From enrollment to the end of treatment at 6 months)
研究者
Daniel London
Assistant Professor
University of Missouri-Columbia