Impact of smart crutches on patient compliance during fracture healing
A Randomized, Parallel, Two Arm, Unblinded Single-center Study of the Effects of Patient-provided Feedback on Fracture Healing and Weight-bearing Status in Orthopedic Patients Undergoing Operative Fixation or Non-operative Treatment of Isolated Tibial Plateau, Pilon, and Other Ankle Fractures
NA · NYU Langone Health · NCT05825079
This study tests if using smart crutches that give feedback can help people with certain leg fractures follow their doctor's instructions better while they heal.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05825079 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether weight-bearing crutch technology that provides active feedback can enhance patient compliance with medical instructions during the healing of specific fractures. Participants will be individuals with isolated tibial plateau, pilon, or ankle fractures who are required to use crutches while in a non-weightbearing status. The intervention involves the use of smart crutch tips designed to deliver real-time feedback to the user. The study will take place at NYU Langone Health, where patients will be monitored for adherence to their treatment protocols.
Who should consider this trial
Good fit: Ideal candidates are individuals with isolated tibial plateau, pilon, or ankle fractures who are required to use crutches and have access to a mobile phone.
Not a fit: Patients with traumatic brain injuries, polytrauma, pathologic fractures, or those who are incarcerated may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could significantly improve patient adherence to treatment, potentially leading to better healing outcomes.
How similar studies have performed: While the specific technology is novel, similar studies have shown that feedback mechanisms can improve patient compliance in other medical contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willing and able to participate in study and complete consent * Will undergo treatment of an isolated tibial plateau, pilon, or ankle fracture and placed in a non-weightbearing status with the use of crutches at NYU. * Have access and use of a mobile phone (exclusively iOS and/or Android devices) Exclusion Criteria: * Patients with concomitant TBI * Polytrauma patients * Pathologic fractures * Prisoners
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Kenneth A. Egol, MD — NYU Langone Health
- Study coordinator: Joseph Robin, MD
- Email: Joseph.robin@nyulangone.org
- Phone: (205)-908-6889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fracture Healing