Smart Crutch Tips to guide weight-bearing after tibial shaft 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 pilot multicenter randomized study will enroll 30 adults (age 18–80) with closed tibial shaft fractures treated by intramedullary nailing or plate fixation and randomize them into three parallel groups. Two intervention groups receive personalized weight-bearing prescriptions based on CT-derived finite element analysis (FEA) delivered as real-time audio/visual feedback through Smart Crutch Tips™, with iterative walking sessions and prescribed strengthening, while the control group uses the device only for data collection and follows standard pain-based progression. Participants will use the device during walking for up to 24 weeks and attend regular follow-up visits to measure radiographic healing time, return to full weight-bearing, safety, practicality, and patient-reported fear of movement. The study compares different personalized loading philosophies, including controlled mechanical stimulation and an optimized Claes-Heigele approach, to identify which approach best promotes safe interfragmentary motion and recovery.

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. Body Mass Index (BMI) between 18.5 and 29.9 kg/m².
5. Diagnosed with a closed tibial shaft fracture (AO/OTA classification: 42-A, 42-B, or 42-C) requiring surgical treatment.
6. Fracture treated exclusively with intramedullary nailing and/or plate fixation
7. No diabetes or well-controlled diabetes (HbA1c ≤ 7.0%).
8. Ability to use crutches without losing balance and medically cleared for partial weight-bearing on the operated limb.
9. Willingness to adhere to the prescribed weight-bearing protocol using the Smart Crutch Tips™ device.
10. Enrollment within 48 hours following surgical intervention.
11. Alcohol consumption (up to 2-3 times per week) within acceptable limits.
12. Willingness to comply with all study procedures, including follow-up visits at weeks 1, 6, 12, 16, 20, 24 and 36 after surgery.
13. 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 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: Nataliia Popova
• Email: nap@comebackmobility.com
• Phone: +380979137440

Similar studies

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

• Robot-assisted closed reduction and internal fixation for distal tibial fractures

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• 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.

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• 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

• Comparing two types of intramedullary nails for healing tibial fractures

  This study is testing whether a new type of tibial nail helps people with stable tibial fractures heal better and recover faster than the standard nail.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama · NCT06679049

• Blood flow restriction–enhanced rehabilitation for people with tibial shaft fractures.

  This trial will test whether using a blood flow restriction device during low-load strengthening exercises helps adults with tibial shaft fractures regain muscle strength and size, heal their fracture, and return to normal function faster than standard exercises alone.

  Recruiting Denver Health and Hospital Authority · Denver, Colorado · NCT06496035

• Assessing knee osteoarthritis in patients with tibial plateau fractures in Norrbotten

  This study looks at how common knee osteoarthritis is in people from Norrbotten, Sweden who had tibial plateau fractures, and it also checks how different factors might affect their recovery.

  Recruiting Umeå University · Luleå, Norrbotten County · NCT06451510

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.