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

Study of Individual Weight-bearing and Iterative Walking Using "ComeBack Mobility" Smart Crutch Tips for Mechanical Stimulation of Tibial Shaft Fracture Healing.

Not applicable Interventional Comeback Mobility Inc · NCT07092579

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.

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 IDNCT07092579 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults 18–80 years with closed AO/OTA 42-A/B/C tibial shaft fractures treated by intramedullary nailing or plate fixation, weighing 40–120 kg with BMI 18.5–29.9, able to use crutches and able to enroll within 48 hours after surgery.

Not a fit: Patients with open fractures, nonoperative management, uncontrolled diabetes, weight or BMI outside the permitted ranges, inability to use crutches, or who present later than 48 hours after surgery are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could shorten healing time, enable earlier safe return to full weight-bearing, and reduce fear of movement after tibial shaft surgery.

How similar studies have performed: Biomechanical and preclinical work supports controlled mechanical stimulation for fracture healing, but FEA-personalized weight-bearing with real-time crutch feedback is largely novel and has limited clinical trial evidence.

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. 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 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 HealingTibial FracturesTibial FractureIntramedullary FixationControlled 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.