Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures

Recruiting now · Not applicable

Conditions studied: Fracture Healing, Treatment Duration, Distal Tibia Fracture

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 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.

Key facts

Study ID

NCT07138066

Run by

Comeback Mobility Inc

People needed

30

Starts

2025-09-29

Expected to finish

2027-01-15

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.
• 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.
• 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, 15, 18, 21, 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 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.
• 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)
• 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)
• 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. 7 — Kyiv, Ukraine (enrolling)
• Kyiv City Clinical Hospital No. 17 — Kyiv, Ukraine
• Institute of Traumatology and orthopedics of the national academy of medical sciences of Ukraine — Kyiv, Ukraine
• Kyiv City Clinical Hospital No. 12 — Kyiv, Ukraine
• Kyiv City Clinical Hospital No. 6 — Kyiv, Ukraine
• Kyiv Regional Council "Kyiv Regional Clinical Hospital" — Kyiv, Ukraine

Full record on ClinicalTrials.gov

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