Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures
Study of Individual Weight-bearing and Iterative Walking Using "ComeBack Mobility" Smart Crutch Tips for Mechanical Stimulation of Tibial Shaft Fracture Healing.
1 other identifier
interventional
30
1 country
18
Brief Summary
The goal of this clinical trial is to learn whether personalized weight-bearing prescriptions using Smart Crutch Tips™ can improve recovery after surgery for tibial shaft fractures. The study will also assess how safe and practical this approach is in daily outpatient use. Can a personalized weight-bearing program based on CT and finite element analysis help the fracture heal faster? Can it help patients return to full weight-bearing sooner? Can it reduce the fear of movement during recovery? Does iterative walking in the early postoperative period support faster or better bone healing? Researchers will compare standard rehabilitation to different types of personalized weight-bearing programs to see which leads to faster healing, earlier mobility, and better outcomes. Participants will: Use Smart Crutch Tips™ during walking for up to 24 weeks; Follow a personalized weight-bearing prescription based on CT scans and biomechanical modeling; Follow a specific walking plan with real-time audio and visual feedback; Attend six follow-up visits over 36 weeks for clinical exams, x-rays, and CT scans; Complete online questionnaires about pain, activity, and fear of movement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2025
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2025
CompletedFirst Posted
Study publicly available on registry
July 30, 2025
CompletedStudy Start
First participant enrolled
October 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 15, 2027
April 14, 2026
April 1, 2026
1 year
July 16, 2025
April 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Radiographic Fracture Union
X-rays will be performed at Visit 1, Visit 2, Visit 3, Visit 4, Visit 5 and Visit 6 postoperatively. CT will be conducted at Visit 0, Visit 1, Visit 2, and optionally at Visit 3 to assess fracture union progression and load adaptation. Fracture Consolidation Assessment Procedure: CT and X-ray data will be evaluated separately. CT criteria include qualitative parameters (fracture line presence, edge clarity, cortical bridging) and quantitative parameters (Hounsfield units at the fracture site). Radiographic assessment will follow the modified RUST scale: Score 1 - no callus, visible line; Score 2 - callus without bridging, visible line; Score 3 - callus with bridging, visible line; Score 4 - callus with bridging, no visible line. The total score ranges from 4 to 16. Fracture is united if at least three cortices are bridged. Delayed union is defined as a visible fracture line and no callus after 3 months.
12 - 24 weeks post-surgery ± 7 days
Secondary Outcomes (6)
mRUST Score
at 6, 12, 16, 20, 24, and 36 weeks after surgery (+- 7 days)
Adherence to Prescribed Axial Loading
from 0 to 36 weeks post-surgery
Lower Extremity Functional Status (LEFS)
0-7 days post-surgery and at 6, 12, 16, 20, 24, 36 weeks after surgery (+- 7 days)
Recording of AEs/SAEs AR/SAAR/SUSARs, including Postoperative Complications
0-7 days post-surgery and at 6, 12, 16, 20, 24, 36 weeks after surgery (+- 7 days)
Pain Level
0-7 days post-surgery and at 6, 12, 16, 20, 24, 36 weeks after surgery (+- 7 days)
- +1 more secondary outcomes
Other Outcomes (9)
Device Usability (System Usability Scale, SUS)
Week 6 post-surgery
Time to Full Weight-Bearing (FWB)
From surgery until full weight-bearing, assessed up to 24 weeks
Analgesic Consumption
At all follow-up visits up to 36 weeks
- +6 more other outcomes
Study Arms (3)
Control Group (Standard of Care)
NO INTERVENTIONParticipants will follow the standard-of-care postoperative weight-bearing protocol according to AO Foundation clinical guidelines: "Partial weight-bearing with crutches is started as soon as the patient is able. Unrestricted weight bearing should be delayed until fracture callus is visible, fibular healing is evident, and weight bearing is without pain. Depending on the consolidation, weight bearing can usually be increased after 6-8 weeks, with full weight-bearing when the fracture has healed." Smart Crutch Tips™ will be used in passive mode, with all notifications (audio and visual) disabled. Participants will not have access to any feedback regarding their weight-bearing. The devices will serve solely for data collection purposes, recording step count and applied loading during ambulation.
Controlled Mechanical Stimulation and Activity (Optimal Interfragmentary Motion)
EXPERIMENTALParticipants will receive individualized weight-bearing prescriptions derived from finite element analysis (FEA) of their postoperative CT scan, targeting optimal interfragmentary motion at the fracture site. Smart Crutch Tips™ will provide real-time audio and visual feedback to support adherence to the prescribed loading and activity program.
Controlled Mechanical Stimulation and Activity According to the Claes-Heigele Theory
EXPERIMENTALParticipants will receive individualized weight-bearing prescriptions derived from finite element analysis (FEA) of their postoperative CT scan, aimed at achieving the highest percentage of voxels in the fracture zone in accordance with the theory of L.E. Claes and C.A. Heigele (1999). Smart Crutch Tips™ will provide real-time audio and visual feedback to support adherence to the prescribed loading and activity program.
Interventions
Participants will perform iterative walking sessions as part of their rehabilitation program. These sessions will be repeated throughout the day, with a minimum 2-hour rest interval between sessions. Step count will be progressively increased over time, according to the individualized rehabilitation plan. In the intervention arms, walking sessions will be guided by real-time auditory and visual feedback from Smart Crutch Tips™.
A structured exercise program prescribed postoperatively to promote functional recovery after tibial shaft fracture surgery. Exercises target quadriceps, hamstrings, gluteal muscles, and ankle/foot mobility to maintain muscle tone, prevent stiffness, and improve circulation. The program includes isometric and dynamic exercises such as: static quadriceps and hamstring contractions, straight leg raises, hip abduction, knee extension, hamstring curls, heel slides, ankle dorsiflexion/plantarflexion, ankle inversion/eversion, ankle circles, toe spreading, and passive ankle stretching using a strap or towel. Exercises are performed in pain-free ranges with gradual progression in repetitions and sets according to the rehabilitation plan. Certain ankle and foot mobility exercises (dorsiflexion/plantarflexion) are also performed hourly during the day to prevent swelling and thrombosis.
Smart Crutch Tips™ are sensor-equipped crutch attachments that measure real-time axial loading during ambulation. The devices connect via Bluetooth to a mobile application and deliver auditory and visual feedback to guide patients toward prescribed weight-bearing levels. The devices continuously record loading and step-count data for clinical monitoring and analysis.
Finite Element Analysis (FEA) is performed up to four times postoperatively to generate individualized weight-bearing prescriptions during rehabilitation. Simulations are based on CT scans and include segmentation and biomechanical modeling of the bone-fixator system. Assessments occur at: 7 days (baseline), 6 weeks, 12 weeks, and optionally at 16 weeks if healing isn't confirmed. Three regions are segmented: fixation system (screws and nail), bone fragments, and fracture gap. Materials: fixator (Titanium Grade 5), bone (mapped into cortical, trabecular, soft tissue, air), and fracture gap (early connective tissue). FEA calculates personalized safe loading based on: (1) Fixator safety (stress \< 290 MPa), (2) Interfragmentary motion (target: 0.5-2.0 mm), and (3) Strain in the fracture gap (octahedral: 0.001-0.05; hydrostatic: 0.001-0.02), supporting biological healing. Output informs weight-bearing prescriptions and step-count targets, delivered via Smart Crutch Tips™ with real-time fee
Eligibility Criteria
You may qualify if:
- Signed informed consent was provided after being fully informed about participation in the study.
- Age: 18 to 80 years for both males and females (pre-menopausal).
- Body weight between 40 and 120 kg.
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m².
- Diagnosed with a closed tibial shaft fracture (AO/OTA classification: 42-A, 42-B, or 42-C) requiring surgical treatment.
- Fracture treated exclusively with intramedullary nailing and/or plate fixation
- No diabetes or well-controlled diabetes (HbA1c ≤ 7.0%).
- Ability to use crutches without losing balance and medically cleared for partial weight-bearing on the operated limb.
- Willingness to adhere to the prescribed weight-bearing protocol using the Smart Crutch Tips™ device.
- Enrollment within 48 hours following surgical intervention.
- Alcohol consumption (up to 2-3 times per week) within acceptable limits.
- Willingness to comply with all study procedures, including follow-up visits at weeks 1, 6, 12, 16, 20, 24 and 36 after surgery.
- Patients with fractures extending into the articular surface of the distal tibial epiphysis may be included, provided that the fracture is deemed stable
You may not qualify if:
- Presence of open or high-energy fractures, multiple lower-limb fractures, or use of bone grafts.
- Fractures classified as 43-B or 43-C according to AO/OTA.
- Chronic alcoholism (defined as \>14 standard drinks per week for men or \>7 for women).
- Presence of metabolic disorders, including uncontrolled thyroid dysfunction, severe renal or hepatic pathology.
- Pathological fractures associated with osteoporosis, osteomyelitis, tumors, metastases, or rickets.
- Lower-limb contractures with functional impairment of grade II or higher.
- Pregnancy or intention to conceive during the study period.
- Psychiatric, cognitive, or neurological disorders that may interfere with adherence to the rehabilitation protocol or effective communication with the study team.
- Clinically significant heart failure (including chronic or acute, with an ejection fraction \<40% or with symptoms such as edema, dyspnea at rest, or orthopnea).
- 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.
- 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).
- Diagnosed epilepsy or other seizure disorders not fully controlled by medication.
- Progressive neurodegenerative diseases (e.g., amyotrophic lateral sclerosis, Huntington's disease, dementia).
- Any sensory, balance, or vestibular disorders that may impair safe use of the investigational device.
- Participation in another clinical study within the past 6 months that could affect the results of the current study.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Kyiv City Clinical Hospital No. 1
Kyiv, Kyiv Oblast, 02091, Ukraine
Municipal Clinical Hospital No. 4 of the Dnipro City Counci
Dnipro, 49102, Ukraine
Communal Non-Profit Enterprise "Regional Family Health Medical Center" of the Dnipropetrovsk Regional Council
Dnipro, Ukraine
Municipal Non-Profit Enterprise "City Clinical Hospital No. 16" of the Dnipro City Council
Dnipro, Ukraine
Municipal Non-Profit Enterprise of the Dnipro Regional Council "Dnipro Regional Clinical Hospital named after Mechnikov"
Dnipro, Ukraine
University Hospital of the Dnipro State Medical University
Dnipro, Ukraine
Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Clinical Hospital of the Ivano-Frankivsk Regional Council"
Ivano-Frankivsk, Ukraine
Railway Clinical Hospital No. 1 of Kyiv Station
Kyiv, 01030, Ukraine
Kyiv City Clinical Hospital No. 17
Kyiv, 01133, Ukraine
Institute of Traumatology and orthopedics of the national academy of medical sciences of Ukraine
Kyiv, 01601, Ukraine
Kyiv City Clinical Hospital No. 12
Kyiv, 02000, Ukraine
Kyiv City Clinical Hospital No. 7
Kyiv, 03179, Ukraine
Kyiv Regional Council "Kyiv Regional Clinical Hospital"
Kyiv, 04106, Ukraine
Kyiv City Clinical Hospital No. 9
Kyiv, 04112, Ukraine
Kyiv City Clinical Hospital No. 8
Kyiv, 04201, Ukraine
State Institution "Feofaniya Clinical Hospital of the State Administration of Affairs"
Kyiv, Ukraine
Municipal Non-Profit Enterprise "Lviv Territorial Medical Association" "Multidisciplinary Clinical Hospital for Intensive Treatment Methods and Emergency Medical Care"
Lviv, Ukraine
Municipal Non-Profit Enterprise "Lviv Territorial Medical Association" "Multidisciplinary Clinical Hospital for Intensive Treatment Methods and Emergency Medical Care"
Lviv, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vaida Glatt, PhD
UT Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Data analysts, FEA specialists and radiologists will also be blinded to group allocation until the database lock
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2025
First Posted
July 30, 2025
Study Start
October 28, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
February 15, 2027
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- IPD and supporting documentation will be made available six months after the publication of the primary results. Data will remain accessible for at least 3 years from that date.
- Access Criteria
- Access to IPD will be granted to qualified researchers affiliated with academic, clinical, or non-profit institutions conducting methodologically sound analyses that align with the objectives of the original study or explore related hypotheses. Requests must include a research proposal, analysis plan, and ethical approval if applicable. All requests will be reviewed by the study's principal investigator and sponsor team based on scientific merit and compliance with data privacy standards.
Time to radiographic fracture union (primary endpoint) mRUST scores at predefined time points Compliance data on axial loading collected by Smart Crutch Tips™ Functional recovery outcomes (LEFS, TSK-17 questionnaire responses) Pain level assessments (VAS) Adverse event data, including AEs, SAEs, ADEs, SADEs, and device deficiencies Gait adherence metrics derived from the CBM mobile app Baseline demographic and clinical information relevant to fracture type and healing (e.g., fracture classification, BMI, CT-derived FEA data)