Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Proximal Tibia Fractures

The goal of this clinical trial is to learn whether personalized weight-bearing prescriptions using Smart Crutch Tips™ can improve recovery after surgery for extra-articular proximal tibia fractures. The study will also assess how safe and practical this approach is in daily outpatient use. Can a personalized weight-bearing program based on CT and finite element analysis help the fracture heal faster? Can it help patients return to full weight-bearing sooner? Can it reduce the fear of movement during recovery? Researchers will compare standard rehabilitation, AO Foundation-based recommendations, and personalized weight-bearing programs derived from finite element analysis (FEA) to determine which approach leads to faster healing, earlier mobility, and better outcomes. Participants will: Use Smart Crutch Tips™ during walking for up to 24 weeks; Follow a personalized weight-bearing prescription based on CT scans and biomechanical modeling; Follow a specific walking plan with real-time audio and visual feedback; Attend eight follow-up visits over 36 weeks for clinical exams, x-rays, and CT scans; Complete online questionnaires about pain, activity, and fear of movement.

NCT Number	NCT07134257
Lead Sponsor	Comeback Mobility Inc
Conditions	Treatment Duration, Fracture Healing, Extra-articular Proximal Tibia Fractures
Enrollment	30 participants
Start Date	2026-06-20
Primary Completion	2026-12-01 (estimated)
Study Completion	2027-04-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-14