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

Study of Individual Weight-bearing and Iterative Walking Using "ComeBack Mobility" Smart Crutch Tips for Mechanical Stimulation of Extra-articular Distal Tibia Fracture Healing

Not applicable Interventional Comeback Mobility Inc · NCT07138066

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.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment30 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorComeback Mobility Inc Industry-sponsored
Locations18 sites (Kyiv, Kyiv Oblast and 17 other locations)
Trial IDNCT07138066 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–80 years with closed extra-articular distal tibia fractures (AO/OTA 43-A1–A3) treated with plates or an intramedullary nail, weighing 40–120 kg, able to use crutches, and enrolled within 48 hours after surgery are ideal candidates.

Not a fit: Patients with open fractures or other fracture types, uncontrolled diabetes, inability to use crutches, weight outside 40–120 kg, or who cannot enroll within 48 hours post-surgery are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could let patients progress to full weight-bearing sooner, speed fracture healing, reduce fear of movement, and make rehabilitation more personalized to each patient.

How similar studies have performed: Controlled mechanical loading and guided weight-bearing have demonstrated benefits for fracture healing in prior work, but combining CT-based finite element analysis with real-time smart-crutch feedback is novel with limited prior clinical testing.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Kyiv, Kyiv Oblast and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Fracture HealingTreatment DurationDistal Tibia Fracturedistal tibia fractureControlled Mechanical LoadingWeight-BearingFinite Element AnalysisDigital Rehabilitation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.