Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures

Recruiting now · Not applicable

Conditions studied: Fracture Healing, Tibial Fractures

In brief

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.

Key facts

Study ID

NCT07092579

Run by

Comeback Mobility Inc

People needed

30

Starts

2025-10-28

Expected to finish

2027-02-15

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%).
• 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.
• Enrollment within 48 hours following surgical intervention.
• Alcohol consumption (up to 2-3 times per week) within acceptable limits.
• Willingness to comply with all study procedures, including follow-up visits at weeks 1, 6, 12, 16, 20, 24 and 36 after surgery.
• Patients with fractures extending into the articular surface of the distal tibial epiphysis may be included, provided that the fracture is deemed stable

You may not qualify if…

• 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.
• Clinically significant heart failure (including chronic or acute, with an ejection fraction <40% or with symptoms such as edema, dyspnea at rest, or orthopnea).
• 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.
• 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).
• Diagnosed epilepsy or other seizure disorders not fully controlled by medication.
• Progressive neurodegenerative diseases (e.g., amyotrophic lateral sclerosis, Huntington's disease, dementia).
• Any sensory, balance, or vestibular disorders that may impair safe use of the investigational device.
• Participation in another clinical study within the past 6 months that could affect the results of the current study.
• Ongoing or planned use of medications known to affect bone healing.

Where it is running

• Kyiv City Clinical Hospital No. 1 — Kyiv, Kyiv Oblast, Ukraine (enrolling)
• Municipal Clinical Hospital No. 4 of the Dnipro City Counci — Dnipro, Ukraine (enrolling)
• Communal Non-Profit Enterprise "Regional Family Health Medical Center" of the Dnipropetrovsk Regional Council — Dnipro, Ukraine (enrolling)
• Municipal Non-Profit Enterprise "City Clinical Hospital No. 16" of the Dnipro City Council — Dnipro, Ukraine (enrolling)
• Municipal Non-Profit Enterprise of the Dnipro Regional Council "Dnipro Regional Clinical Hospital named after Mechnikov" — Dnipro, Ukraine (enrolling)
• University Hospital of the Dnipro State Medical University — Dnipro, Ukraine (enrolling)
• Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Clinical Hospital of the Ivano-Frankivsk Regional Council" — Ivano-Frankivsk, Ukraine (enrolling)
• Municipal Non-Profit Enterprise "Lviv Territorial Medical Association" "Multidisciplinary Clinical Hospital for Intensive Treatment Methods and Emergency Medical Care" — Lviv, Ukraine (enrolling)
• Municipal Non-Profit Enterprise "Lviv Territorial Medical Association" "Multidisciplinary Clinical Hospital for Intensive Treatment Methods and Emergency Medical Care" — Lviv, Ukraine (enrolling)
• Kyiv City Clinical Hospital No. 17 — Kyiv, Ukraine (enrolling)
• Kyiv City Clinical Hospital No. 12 — Kyiv, Ukraine (enrolling)
• Kyiv City Clinical Hospital No. 7 — Kyiv, Ukraine (enrolling)
• Kyiv Regional Council "Kyiv Regional Clinical Hospital" — Kyiv, Ukraine (enrolling)
• Kyiv City Clinical Hospital No. 9 — Kyiv, Ukraine (enrolling)
• Kyiv City Clinical Hospital No. 8 — Kyiv, Ukraine (enrolling)
• State Institution "Feofaniya Clinical Hospital of the State Administration of Affairs" — Kyiv, Ukraine (enrolling)
• Railway Clinical Hospital No. 1 of Kyiv Station — Kyiv, Ukraine
• Institute of Traumatology and orthopedics of the national academy of medical sciences of Ukraine — Kyiv, Ukraine

Full record on ClinicalTrials.gov

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