Personalized smart-crutch guidance for weight-bearing after distal tibia surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot multicenter study will enroll 30 adults (18–80) with closed extra-articular distal tibia fractures fixed with plates or intramedullary nails and randomize them into three parallel groups: standard care, AO Foundation–guided partial weight-bearing with feedback, and FEA-derived personalized loading with iterative walking protocols. Participants will use Smart Crutch Tips™ for up to 24 weeks while following assigned weight-bearing prescriptions, a lower-limb rehabilitation exercise program, and orthopaedic footwear where indicated, with continuous sensor data collection. Primary outcomes include radiographic fracture healing time, time to full weight-bearing, mobility measures and fear-of-movement, plus safety and outpatient feasibility. Follow-up visits are scheduled at weeks 1, 6, 12, 15, 18, 21, 24, and 36 after surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed informed consent was provided after being fully informed about participation in the study.
2. Age: 18 to 80 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: 43- А1, 43-А2, 43-А3) requiring surgical treatment.
5. Fracture treated exclusively with plates and/or with an intramedullary nail
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, 6, 12, 15, 18, 21, 24, and 36 after surgery.
12. Patients with fractures extending into the articular surface of the distal tibial epiphysis may be included, provided that the fracture is deemed stable."

Exclusion Criteria:

1. Presence of open or high-energy fractures, multiple lower-limb fractures, or use of bone grafts.
2. Fractures classified as 41-A, 41-B, or 42 -A,B 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.

Where it's running

• Kyiv City Clinical Hospital No. 1
  Kyiv, Kyiv Oblast, Ukraine Recruiting
• Municipal Clinical Hospital No. 4 of the Dnipro City Counci
  Dnipro, Ukraine Recruiting
• Communal Non-Profit Enterprise "Regional Family Health Medical Center" of the Dnipropetrovsk Regional Council
  Dnipro, Ukraine Recruiting
• Municipal Non-Profit Enterprise "City Clinical Hospital No. 16" of the Dnipro City Council
  Dnipro, Ukraine Recruiting
• Municipal Non-Profit Enterprise of the Dnipro Regional Council "Dnipro Regional Clinical Hospital named after Mechnikov"
  Dnipro, Ukraine Recruiting
• University Hospital of the Dnipro State Medical University
  Dnipro, Ukraine Recruiting

Study contacts

• Principal investigator: Vaida Glatt, PhD — UT Health
• Study coordinator: Nataliia POPOVA
• Email: nap@comebackmobility.com
• Phone: +380979137440

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Smart Crutch Tips to guide weight-bearing after extra-articular proximal tibia fracture surgery

  This study will test whether personalized weight-bearing plans using Smart Crutch Tips help adults with extra-articular proximal tibia fractures heal faster, return to full weight-bearing sooner, and feel less fear of movement.

  Recruiting at 13 sites Comeback Mobility Inc · Kyiv, Kyiv Oblast and 17 other locations · NCT07134257

• Smart Crutch Tips to guide weight-bearing after tibial shaft fracture surgery

  This trial will test whether personalized, CT- and computer-model-based weight-bearing plans delivered through Smart Crutch Tips™ help adults recovering from surgically fixed tibial shaft fractures heal faster and return to full walking sooner.

  Recruiting at 16 sites Comeback Mobility Inc · Kyiv, Kyiv Oblast and 17 other locations · NCT07092579

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.