Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures

NCT07138066 | Recruiting

• 1 other identifier: CBM-UA-WB -2025/2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 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 extra-articular distal tibia 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? Researchers will compare standard rehabilitation, AO Foundation-based recommendations, and personalized weight-bearing programs derived from finite element analysis (FEA) to determine which approach 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 eight follow-up visits over 36 weeks for clinical exams, x-rays, and CT scans; Complete online questionnaires about pain, activity, and fear of movement.

Conditions

Fracture Healing; Treatment Duration; Distal Tibia Fracture

Keywords

distal tibia fracture; Fracture Healing; Controlled Mechanical Loading; Weight-Bearing; Finite Element Analysis; Digital Rehabilitation; Smart Crutch Tips; Bone Union; Rehabilitation Monitoring; Lower Limb Fractures; Biofeedback Device

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, Visit 7 postoperatively. CT will be conducted at Visit 0, Visit 1, Visit 2, and 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, 15, 18, 21, 24, 36 weeks after surgery (+- 7 days)

• Adherence to Prescribed Axial Loading

  from 0 to 36 weeks post-surgery

• Lower Extremity Functional Status (LEFS)

  0-8 days post-surgery and at 6, 12, 15, 18, 21, 24, 36 weeks after surgery (+- 7 days)

• Recording of AEs/SAEs AR/SAAR/SUSARs, including Postoperative Complications

  0-8 days post-surgery and at 6, 12, 15, 18, 21, 24, 36 weeks after surgery (+- 7 days)

• Pain Level

  0-8 days post-surgery and at 6, 12, 15, 18, 21, 24, 36 weeks after surgery (+- 7 days)

Other Outcomes (8)

• Time to Full Weight-Bearing (FWB)

  From surgery until full weight-bearing, assessed up to 24 weeks

• Analgesic Consumption

  0-8 days post-surgery and at 6, 12, 15, 18, 21, 24, 36 weeks after surgery (+- 7 days)

• Antidepressant Consumption

  0-8 days post-surgery and at 6, 12, 15, 18, 21, 24, 36 weeks after surgery (+- 7 days)

Study Arms (3)

Control Group (Standard of Care)

NO INTERVENTION

Patients in this group receive standard clinical recommendations for weight-bearing progression without the use of digital monitoring tools, specifically six to ten weeks of non-weight-bearing. Axial loading instructions are provided by the treating physician based on clinical examination and radiographic findings. The decision to initiate full weight-bearing is made individually, without objective device-based monitoring. However, patients in this group are provided with Smart Crutch Tips™ that passively monitor gait parameters without providing visual or auditory cues. This allows the collection of adherence data without interfering with the clinical process. Such an approach reflects real-world clinical practice and serves as a comparator for evaluating the effectiveness of personalized strategies.

Controlled Mechanical Stimulation According to AO Guidelines

EXPERIMENTAL

Participants in this group receive recommendations for weight-bearing progression in accordance with AO guidelines (10-20 kg load). Axial loading is monitored in real time using Smart Crutch Tips™, which provide visual and auditory feedback.

Device: Smart Crutch Tips™; Procedure: Finite Element Analysis (FEA); Device: Orthopedic shoes for use during rehabilitation period

Personalized Controlled Mechanical Stimulation (FEA)

EXPERIMENTAL

Participants 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.

Device: Smart Crutch Tips™; Procedure: Finite Element Analysis (FEA); Behavioral: Iterative walking; Procedure: Lower Limb Rehabilitation Exercise Program; Device: Orthopedic shoes for use during rehabilitation period

Interventions

Orthopedic shoes for use during rehabilitation period DEVICE

Patients are provided with orthopedic shoes to be worn during the rehabilitation period (up to 6-10 weeks).

Controlled Mechanical Stimulation According to AO Guidelines; Personalized Controlled Mechanical Stimulation (FEA)

Smart Crutch Tips™ DEVICE

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.

Controlled Mechanical Stimulation According to AO Guidelines; Personalized Controlled Mechanical Stimulation (FEA)

Finite Element Analysis (FEA) PROCEDURE

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: 8 days (baseline), 6 weeks, 12 weeks, and 15 weeks. 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

Controlled Mechanical Stimulation According to AO Guidelines; Personalized Controlled Mechanical Stimulation (FEA)

Iterative walking BEHAVIORAL

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.

Personalized Controlled Mechanical Stimulation (FEA)

Lower Limb Rehabilitation Exercise Program PROCEDURE

The program consists of a structured set of isometric and dynamic exercises targeting the quadriceps, hamstrings, gluteal muscles, and ankle/foot mobility. Exercises are performed in a supine, prone, or seated position, as appropriate, with 2 sets of 5-12 repetitions or sustained holds of 20-30 seconds, progressing gradually according to the rehabilitation plan. All movements are conducted within a pain-free range (not exceeding 4/10 on the VAS scale), with additional hourly ankle mobility work prescribed to reduce swelling and prevent thrombosis.

Personalized Controlled Mechanical Stimulation (FEA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• Diagnosed with a closed tibial shaft fracture (AO/OTA classification: 43- А1, 43-А2, 43-А3) requiring surgical treatment.
• Fracture treated exclusively with plates and/or with an intramedullary nail
• 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, 15, 18, 21, 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 41-A, 41-B, or 42 -A,B 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.

Sponsors & Collaborators

• Comeback Mobility Inc: lead

Study Sites (18)

Kyiv City Clinical Hospital No. 1

Kyiv, Kyiv Oblast, 02091, Ukraine

RECRUITING

Municipal Clinical Hospital No. 4 of the Dnipro City Counci

Dnipro, 49102, Ukraine

RECRUITING

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

Dnipro, Ukraine

RECRUITING

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

Dnipro, Ukraine

RECRUITING

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

Dnipro, Ukraine

RECRUITING

University Hospital of the Dnipro State Medical University

Dnipro, Ukraine

RECRUITING

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

Ivano-Frankivsk, Ukraine

RECRUITING

Kyiv City Clinical Hospital No. 17

Kyiv, 01133, Ukraine

NOT YET RECRUITING

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

Kyiv, 01601, Ukraine

NOT YET RECRUITING

Kyiv City Clinical Hospital No. 12

Kyiv, 02000, Ukraine

NOT YET RECRUITING

Kyiv City Clinical Hospital No. 6

Kyiv, 03126, Ukraine

NOT YET RECRUITING

Kyiv City Clinical Hospital No. 7

Kyiv, 03179, Ukraine

RECRUITING

Kyiv Regional Council "Kyiv Regional Clinical Hospital"

Kyiv, 04106, Ukraine

NOT YET RECRUITING

Kyiv City Clinical Hospital No. 9

Kyiv, 04112, Ukraine

RECRUITING

Kyiv City Clinical Hospital No. 8

Kyiv, 04201, Ukraine

RECRUITING

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

Kyiv, Ukraine

RECRUITING

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

Lviv, Ukraine

RECRUITING

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

Lviv, Ukraine

RECRUITING

MeSH Terms

Interventions

Finite Element Analysis

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Vaida Glatt, PhD

  UT Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nataliia POPOVA

CONTACT

+380979137440; nap@comebackmobility.com

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: August 15, 2025
• First Posted: August 22, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 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.

Locations

UA (18)