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

Launched by COMEBACK MOBILITY INC · Aug 15, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether a new tool called Smart Crutch Tips™ can help people recover better after surgery for a specific type of lower leg fracture near the ankle (called an extra-articular distal tibia fracture). The Smart Crutch Tips™ provide personalized guidance on how much weight a patient should put on their injured leg while walking, based on detailed scans and computer models of their bone. Researchers want to see if this personalized approach helps the bone heal faster, allows patients to walk more normally sooner, and reduces the fear of moving during recovery compared to standard care.

Adults aged 18 to 60 who have had surgery to fix a closed fracture in the lower leg bone and meet certain health criteria may be eligible to join. Participants will use the Smart Crutch Tips™ while walking for up to 24 weeks, following a special plan tailored just for them. They will receive real-time feedback to help them walk safely and correctly. Over about nine months, they will attend regular check-ups with X-rays and scans, and answer questions about their pain, activity levels, and confidence in moving around. This study aims to find out if this high-tech, personalized support can make recovery smoother and more effective for patients with these fractures.

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: 43- А1, 43-А2, 43-А3) requiring surgical treatment.
• • 5. Fracture treated exclusively with plates
• • 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, 6, 12, 15, 18, 21, 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 41-A, 41-B, or 42 -A,B 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.