Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Proximal … (NCT07134257) | Clinical Trial Compass
RecruitingNot Applicable
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Proximal Tibia Fractures
Ukraine30 participantsStarted 2026-06-20
Plain-language summary
The goal of this clinical trial is to learn whether personalized weight-bearing prescriptions using Smart Crutch Tipsâ„¢ can improve recovery after surgery for extra-articular proximal 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 Tipsâ„¢ 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
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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: 41-A2, 41-A3) requiring surgical treatment.
✓. Fracture treated with a plate 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 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.