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

Launched by COMEBACK MOBILITY INC · Aug 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people recover after surgery for certain types of tibia (shinbone) fractures near the knee. It focuses on using a special device called Smart Crutch Tips™ that provides personalized guidance on how much weight to put on the injured leg while walking. The goal is to see if this personalized approach helps the bone heal faster, allows patients to start walking normally sooner, and reduces fear of moving during recovery compared to standard rehabilitation methods.

People eligible for this study are adults between 18 and 60 years old who have had surgery to fix a closed fracture in the upper part of the shinbone using a specific type of nail inside the bone. Participants must be able to safely use crutches and follow a weight-bearing plan. During the study, participants will use the Smart Crutch Tips™ while walking for up to 24 weeks, receiving real-time feedback to guide their steps. They will also attend eight follow-up visits over about nine months for check-ups and imaging tests, and complete questionnaires about their pain and activity levels. This study will help researchers understand if personalized walking guidance can improve healing and recovery after this type of leg fracture.

Gender

ALL

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 intramedullary nailing (intramedullary fixation without additional plates or external fixation).
• • 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-energy fractures, multiple lower-limb fractures, or use of bone grafts.
• • 2. Fractures classified as 43-B or 43-C according to AO/OTA.
• • 3. Chronic alcoholism (defined as \>14 standard drinks per week for men or \>7 for women).
• • 4. Presence of metabolic disorders, including uncontrolled thyroid dysfunction, severe renal or hepatic pathology.
• • 5. Pathological fractures associated with osteoporosis, osteomyelitis, tumors, metastases, or rickets.
• • 6. Lower-limb contractures with functional impairment of grade II or higher.
• • 7. Pregnancy or intention to conceive during the study period.
• • 8. Psychiatric, cognitive, or neurological disorders that may interfere with adherence to the rehabilitation protocol or effective communication with the study team.
• • 9. Clinically significant heart failure (including chronic or acute, with an ejection fraction \<40% or with symptoms such as edema, dyspnea at rest, or orthopnea).
• • 10. Pulmonary insufficiency of any origin, accompanied by chronic hypoxemia (PaO₂ \< 60 mmHg) or hypercapnia (PaCO₂ \> 45 mmHg), requiring oxygen support or significantly limiting physical activity.
• • 11. Clinically significant neurological disorders that may affect motor function, coordination, or physical activity (e.g., stroke with residual deficits, Parkinson's disease, multiple sclerosis, cerebral palsy).
• • 12. Diagnosed epilepsy or other seizure disorders not fully controlled by medication.
• • 13. Progressive neurodegenerative diseases (e.g., amyotrophic lateral sclerosis, Huntington's disease, dementia).
• • 14. Any sensory, balance, or vestibular disorders that may impair safe use of the investigational device.
• • 15. Participation in another clinical study within the past 6 months that could affect the results of the current study.
• • 16. Ongoing or planned use of medications known to affect bone healing.