NCT07138066 Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures
| NCT ID | NCT07138066 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Comeback Mobility Inc |
| Condition | Fracture Healing |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-09-29 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-09-29 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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 80 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 and/or with an intramedullary nail 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. 12. Patients with fractures extending into the articular surface of the distal tibial epiphysis may be included, provided that the fracture is deemed stable." 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.
Contact & Investigator
Vaida Glatt, PhD
PRINCIPAL INVESTIGATOR
UT Health
Frequently Asked Questions
Who can join the NCT07138066 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Fracture Healing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07138066 currently recruiting?
Yes, NCT07138066 is actively recruiting participants. Contact the research team at nap@comebackmobility.com for enrollment information.
Where is the NCT07138066 trial being conducted?
This trial is being conducted at Kyiv, Ukraine, Dnipro, Ukraine, Dnipro, Ukraine, Dnipro, Ukraine and 11 additional locations.
Who is sponsoring the NCT07138066 clinical trial?
NCT07138066 is sponsored by Comeback Mobility Inc. The principal investigator is Vaida Glatt, PhD at UT Health. The trial plans to enroll 30 participants.