Smart Crutch Tips to guide weight-bearing after extra-articular proximal tibia fracture 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 is a pilot multicenter trial that will enroll 30 adults with closed extra-articular proximal tibia fractures (AO/OTA 41-A2, 41-A3) treated with plates and/or intramedullary nails and allocate them to three parallel groups. All participants will use Smart Crutch Tips™ during walking for up to 24 weeks while following either standard practice (no load for six weeks), AO Foundation partial weight-bearing recommendations, or a personalized loading program derived from CT-based finite element analysis (FEA) with iterative walking protocols and targeted exercises. The Smart Crutch Tips™ will collect data in all groups and provide real-time visual/auditory feedback in the AO and FEA groups to enforce target loads. Outcomes include time to radiographic union, time to full weight-bearing, safety and feasibility in outpatient use, and patient-reported fear of movement, with follow-up visits through 36 weeks 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: 41-A2, 41-A3) requiring surgical treatment.
5. Fracture treated with a plate 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, 4, 8, 12, 15, 18, 24, and 36 after surgery.
12. Stable fractures of the proximal tibia with partial extension of the fracture line into the articular surface are eligible

Exclusion Criteria:

1. Presence of open or high-energy fractures, multiple lower-limb fractures, or use of bone grafts.
2. Fractures classified as 43-B or 43-C 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: Illia Popov
• Email: popov@comebackmobility.com
• Phone: 13476197319

Similar studies

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

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

  This project will try Smart Crutch Tips with CT-and-FEA–based personalized weight-bearing plans for adults recovering from extra-articular distal tibia fractures to see if they heal faster and return to full walking sooner.

  Recruiting at 13 sites Comeback Mobility Inc · Kyiv, Kyiv Oblast and 17 other locations · NCT07138066

• 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.