Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures (NCT07092579) | Clinical Trial Compass
RecruitingNot Applicable
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures
Ukraine30 participantsStarted 2025-10-28
Plain-language 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 tibial shaft 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? Does iterative walking in the early postoperative period support faster or better bone healing? Researchers will compare standard rehabilitation to different types of personalized weight-bearing programs to see which 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 six follow-up visits over 36 weeks for clinical exams, x-rays, and CT scans; Complete online questionnaires about pain, activity, and fear of movement.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed informed consent was provided after being fully informed about participation in the study.
. Age: 18 to 80 years for both males and females (pre-menopausal).
. Body weight between 40 and 120 kg.
. Body Mass Index (BMI) between 18.5 and 29.9 kg/m².
. Diagnosed with a closed tibial shaft fracture (AO/OTA classification: 42-A, 42-B, or 42-C) requiring surgical treatment.
. Fracture treated exclusively with intramedullary nailing and/or plate fixation
. No diabetes or well-controlled diabetes (HbA1c ≤ 7.0%).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Ability to use crutches without losing balance and medically cleared for partial weight-bearing on the operated limb.
Exclusion criteria
. Presence of open or high-energy fractures, multiple lower-limb fractures, or use of bone grafts.
. Fractures classified as 43-B or 43-C 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.