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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07092579

Personalized Weight-Bearing Using Smart Crutch Tips to Improve Healing After Surgery for Tibial Shaft Fractures

Led by Comeback Mobility Inc · Updated on 2026-04-14

30

Participants Needed

18

Research Sites

15 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to determine whether personalized weight-bearing prescriptions using Smart Crutch Tips2 can improve recovery after surgery for tibial shaft fractures. It evaluates if a weight-bearing program based on CT scans and biomechanical analysis can promote faster fracture healing, earlier full weight-bearing, reduced fear of movement, and better outcomes. The trial compares standard rehabilitation to two types of personalized weight-bearing programs in adult patients with surgically treated tibial shaft fractures. Participants are divided into three groups one follows standard care with Smart Crutch Tips2 used only for data collection without feedback the other two receive personalized weight-bearing prescriptions derived from finite element analysis of their CT scans. These two groups use Smart Crutch Tips2 to receive real-time audio and visual feedback during walking and follow a specific rehabilitation plan including iterative walking sessions and lower limb strengthening exercises. The devices are used for up to 24 weeks or as needed during outpatient crutch use. Participants attend seven in-person visits from screening up to 36 weeks post-surgery, including clinical exams, X-rays, and CT scans at specified time points to monitor healing and adjust prescriptions. They complete online questionnaires assessing pain, activity, and fear of movement, and provide usability feedback on the device. Data is continuously collected through the Smart Crutch Tips2 and a mobile app to track adherence and outcomes. The primary measure is time to fracture union between 12 and 24 weeks post-surgery.

CONDITIONS

Brief Title

Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures

Research Team

N

Nataliia Popova

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