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Smart crutches could speed up bone healing after leg fractures

NCT ID NCT07092579

Disease control Sponsor: Comeback Mobility Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether special crutch tips that measure how much weight you put on your leg can help a broken shinbone heal better. Thirty people who had surgery for a tibial fracture will use the smart tips for up to 24 weeks, following a personalized walking plan based on CT scans. Researchers will track bone healing with X-rays and CT scans over 36 weeks to see if this approach leads to faster recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Smart Crutch Tips™ (sensor-equipped crutch attachments providing real-time weight-bearing feedback)
What this could lead to
If successful, this could lead to faster and more reliable bone healing after tibial fractures, helping patients return to walking sooner with less fear of movement.
What could go wrong
This is a small early-stage trial with only 30 participants, so results may not apply to everyone. The device is new and its benefits over standard care are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

tibia fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fracture healing Tibial fractures

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Communal Non-Profit Enterprise "Regional Family Health Medical Center" of the Dnipropetrovsk Regional Council

    RECRUITING

    Dnipro, Ukraine

  • Institute of Traumatology and orthopedics of the national academy of medical sciences of Ukraine

    NOT_YET_RECRUITING

    Kyiv, 01601, Ukraine

  • Kyiv City Clinical Hospital No. 1

    RECRUITING

    Kyiv, Kyiv Oblast, 02091, Ukraine

  • Kyiv City Clinical Hospital No. 12

    RECRUITING

    Kyiv, 02000, Ukraine

  • Kyiv City Clinical Hospital No. 17

    RECRUITING

    Kyiv, 01133, Ukraine

  • Kyiv City Clinical Hospital No. 7

    RECRUITING

    Kyiv, 03179, Ukraine

  • Kyiv City Clinical Hospital No. 8

    RECRUITING

    Kyiv, 04201, Ukraine

  • Kyiv City Clinical Hospital No. 9

    RECRUITING

    Kyiv, 04112, Ukraine

  • Kyiv Regional Council "Kyiv Regional Clinical Hospital"

    RECRUITING

    Kyiv, 04106, Ukraine

  • Municipal Clinical Hospital No. 4 of the Dnipro City Counci

    RECRUITING

    Dnipro, 49102, Ukraine

  • Municipal Non-Profit Enterprise "City Clinical Hospital No. 16" of the Dnipro City Council

    RECRUITING

    Dnipro, Ukraine

  • Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Clinical Hospital of the Ivano-Frankivsk Regional Council"

    RECRUITING

    Ivano-Frankivsk, Ukraine

  • Municipal Non-Profit Enterprise "Lviv Territorial Medical Association" "Multidisciplinary Clinical Hospital for Intensive Treatment Methods and Emergency Medical Care"

    RECRUITING

    Lviv, Ukraine

  • Municipal Non-Profit Enterprise "Lviv Territorial Medical Association" "Multidisciplinary Clinical Hospital for Intensive Treatment Methods and Emergency Medical Care"

    RECRUITING

    Lviv, Ukraine

  • Municipal Non-Profit Enterprise of the Dnipro Regional Council "Dnipro Regional Clinical Hospital named after Mechnikov"

    RECRUITING

    Dnipro, Ukraine

  • Railway Clinical Hospital No. 1 of Kyiv Station

    NOT_YET_RECRUITING

    Kyiv, 01030, Ukraine

  • State Institution "Feofaniya Clinical Hospital of the State Administration of Affairs"

    RECRUITING

    Kyiv, Ukraine

  • University Hospital of the Dnipro State Medical University

    RECRUITING

    Dnipro, Ukraine

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