Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Ti… (NCT07138066) | Clinical Trial Compass
RecruitingNot Applicable
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures
Ukraine30 participantsStarted 2025-09-29
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 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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.
✓. Diagnosed with a closed tibial shaft fracture (AO/OTA classification: 43- А1, 43-А2, 43-А3) requiring surgical treatment.
✓. Fracture treated exclusively with plates and/or with an intramedullary nail
✓. 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.
Exclusion criteria
✕. 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.