Status:
RECRUITING
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures
Lead Sponsor:
Comeback Mobility Inc
Conditions:
Fracture Healing
Treatment Duration
Eligibility:
All Genders
18-60 years
Phase:
NA
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 distal tibia fractures. Th...
Detailed Description
This is a pilot multicenter clinical trial designed to explore the impact of individualized weight-bearing regimens and iterative walking protocols on the healing of extra-articular distal tibia fract...
Eligibility Criteria
Inclusion
- Signed informed consent was provided after being fully informed about participation in the study.
- Age: 18 to 60 years for both males and females (pre-menopausal).
- Body weight between 40 and 120 kg.
- Diagnosed with a closed tibial shaft fracture (AO/OTA classification: 43- А1, 43-А2, 43-А3) requiring surgical treatment.
- Fracture treated exclusively with plates
- No diabetes or well-controlled diabetes (HbA1c ≤ 7.0%).
- Ability to use crutches without losing balance and medically cleared for partial weight-bearing on the operated limb.
- Willingness to adhere to the prescribed weight-bearing protocol using the Smart Crutch Tips™ device.
- Enrollment within 48 hours following surgical intervention.
- Alcohol consumption (up to 2-3 times per week) within acceptable limits.
- 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
- Presence of open or high-energy fractures, multiple lower-limb fractures, or use of bone grafts.
- Fractures classified as 41-A, 41-B, or 42 -A,B according to AO/OTA.
- Chronic alcoholism (defined as \>14 standard drinks per week for men or \>7 for women).
- Presence of metabolic disorders, including uncontrolled thyroid dysfunction, severe renal or hepatic pathology.
- Pathological fractures associated with osteoporosis, osteomyelitis, tumors, metastases, or rickets.
- Lower-limb contractures with functional impairment of grade II or higher.
- Pregnancy or intention to conceive during the study period.
- Psychiatric, cognitive, or neurological disorders that may interfere with adherence to the rehabilitation protocol or effective communication with the study team.
- Clinically significant heart failure (including chronic or acute, with an ejection fraction \<40% or with symptoms such as edema, dyspnea at rest, or orthopnea).
- 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.
- 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).
- Diagnosed epilepsy or other seizure disorders not fully controlled by medication.
- Progressive neurodegenerative diseases (e.g., amyotrophic lateral sclerosis, Huntington's disease, dementia).
- Any sensory, balance, or vestibular disorders that may impair safe use of the investigational device.
- Participation in another clinical study within the past 6 months that could affect the results of the current study.
- Ongoing or planned use of medications known to affect bone healing.
Key Trial Info
Start Date :
September 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07138066
Start Date
September 29 2025
End Date
July 15 2026
Last Update
October 2 2025
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Kyiv City Clinical Hospital No. 1
Kyiv, Kyiv Oblast, Ukraine, 02091
2
Municipal Clinical Hospital No. 6 of the Dnipro City Counci
Dnipro, Ukraine, 49074
3
Municipal Clinical Hospital No. 4 of the Dnipro City Counci
Dnipro, Ukraine, 49102
4
Kyiv City Clinical Hospital No. 17
Kyiv, Ukraine, 01133