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

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

Not applicable Interventional Comeback Mobility Inc · NCT07134257

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.

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 IDNCT07134257 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–80 with a closed extra-articular proximal tibia fracture (AO/OTA 41-A2 or 41-A3) treated surgically with plate and/or intramedullary nail, weighing 40–120 kg, able to use crutches, and enrolled within 48 hours after surgery are the ideal candidates.

Not a fit: Patients with open or unstable fractures, inability to use crutches, uncontrolled diabetes or other major comorbidities, body weight outside 40–120 kg, or who cannot attend the planned follow-up visits are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, personalized FEA-guided loading with Smart Crutch Tips could shorten time to bone union and speed return to full weight-bearing while reducing fear of movement during recovery.

How similar studies have performed: Guided weight-bearing and controlled mechanical loading approaches have shown promise in preclinical work and small clinical pilots, but CT/FEA-based personalized loading for proximal tibia fractures is largely novel and not yet proven in larger trials.

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: 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 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 Treatment DurationFracture HealingExtra-articular Proximal Tibia FracturesControlled Mechanical LoadingWeight-BearingFinite Element AnalysisBone UnionDigital 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.