Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Proximal Tibia Fractures
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent was provided after being fully informed about participation in the study. 2. Age: 18 to 60 years for both males and females (pre-menopausal). 3. Body weight between 40 and 120 kg. 4. Diagnosed with a closed tibial shaft fracture (AO/OTA classification: 41-A2, 41-A3) requiring surgical treatment. 5. Fracture treated exclusively with a plate. 6. No diabetes or well-controlled diabetes (HbA1c ≤ 7.0%). 7. Ability to use crutches without losing balance and medically cleared for partial weight-bearing on the operated limb. 8. Willingness to adhere to the prescribed weight-bearing protocol using the Smart Crutch Tips™ device. 9. Enrollment within 48 hours following surgical intervention. 10. Alcohol consumption (up to 2-3 times per week) within acceptable limits. 11. Willingness to comply with all study procedures, including follow-up visits at weeks 1, 4, 8, 12, 15, 18, 24, and 36 after surgery. Exclusion Criteria: 1. Presence of open or high-en