Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT07134257
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: 41-A2, 41-A3) requiring surgical treatment.
5. Fracture treated exclusively with a plate.
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, 4, 8, 12, 15, 18, 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07134257
Study Brief:
Protocol Section:
NCT07134257