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

Launched by COMEBACK MOBILITY INC · Jul 23, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new way to help people recover after surgery for a broken shinbone (tibial shaft fracture). It uses a special device called Smart Crutch Tips™, which gives personalized guidance on how much weight to put on the injured leg while walking. The goal is to see if this tailored approach can help the bone heal faster, allow patients to walk normally sooner, reduce pain and fear of movement, and improve overall quality of life compared to standard rehabilitation.

The study is looking for adults aged 18 to 60 who have had surgery to fix a closed fracture of the shinbone using a specific type of nail inside the bone. Participants need to be able to use crutches safely and be willing to follow a personalized walking plan that includes real-time feedback from the Smart Crutch Tips™. Over about six months, participants will use these special crutches, attend six check-up visits for exams and scans, and complete online surveys about their pain and activity. This study is not yet recruiting, but if you meet the criteria and want to improve your recovery after a tibial fracture, this trial may be of interest.

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. Body Mass Index (BMI) between 18.5 and 29.9 kg/m².
• • 5. Diagnosed with a closed tibial shaft fracture (AO/OTA classification: 42-A, 42-B, or 42-C) requiring surgical treatment.
• • 6. Fracture treated exclusively with intramedullary nailing (intramedullary fixation without additional plates or external fixation).
• • 7. No diabetes or well-controlled diabetes (HbA1c ≤ 7.0%).
• • 8. Ability to use crutches without losing balance and medically cleared for partial weight-bearing on the operated limb.
• • 9. Willingness to adhere to the prescribed weight-bearing protocol using the Smart Crutch Tips™ device.
• • 10. Enrollment within 48 hours following surgical intervention.
• • 11. Alcohol consumption (up to 2-3 times per week) within acceptable limits.
• • 12. Willingness to comply with all study procedures, including follow-up visits at weeks 1, 6, 12, 16, 20, 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.