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

Официальное название

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

Обзор

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 proximal 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.

Подробное описание

This is a pilot multicenter clinical trial designed to explore the impact of individualized weight-bearing regimens and iterative walking protocols on the healing of extra-articular proximal tibia fractures. The study will enroll 30 adult participants (aged 18-80) with closed proximal tibia fractures (AO/OTA 41-A2, 41-A3) treated with plates and/or with an intramedullary nail. Participants will be allocated into three parallel groups (ten participants per group).

Group 1 - Control (Standard Practice):

During the first six weeks, participants will not load the operated leg. After this period, they will gradually increase weight-bearing within pain tolerance. Smart Crutch Tips™ will be used with indicators turned off (data collection only, without feedback).

Group 2 - AO Foundation Recommendations:

Participants will be allowed partial weight-bearing (touchdown or 10-15 kg load) with crutches or walkers according to AO Foundation guidelines. Smart Crutch Tips™ will be used with indicators turned on, providing real-time feedback on loading level.

Group 3 - FEA-Based Personalized Loading:

Participants will receive individualized axial loading prescriptions developed using finite element analysis (FEA). Smart Crutch Tips™ will be used with visual and auditory real-time feedback. In addition to personalized loading, participants will follow an iterative walking protocol. Participants will also perform a set of isometric and dynamic exercises to strengthen the lower limb muscles

Study Objectives:

The primary aim is to determine whether providing precise, data-driven weight-bearing recommendations-delivered via Smart Crutch Tips™ with real-time visual and auditory feedback-can enhance fracture healing by promoting safe interfragmentary motion.

Device Use and Follow-Up:

Participants will use ComeBack Mobility Smart Crutch Tips™ whenever they use crutches in an outpatient setting for up to 24 weeks, depending on their healing progress. These devices provide real-time guidance to help users stay within their prescribed weight-bearing range and transmit data to a centralized monitoring platform.

Participants will attend eight in-person follow-up visits: screening (Day 0-8) and then at 4, 8, 12, 15, 18, 24, and 36 weeks post-surgery. At each follow-up visit starting from Visit 1 (4 weeks), radiographic assessments (X-ray) will be performed to monitor fracture healing. Computed tomography (CT) scans will be conducted at specific time points: during the screening period (0-7 days post-surgery) and prior to Visit 1 (4 weeks), Visit 2 (8 weeks), and optionally before Visit 3 (12 weeks) , to adjust weight-bearing prescriptions and assess consolidation dynamics.

Data Collection:

Clinical data will be collected via the ComeBack Mobility app and electronic case report forms (eCRFs). Before each follow-up visit, participants will complete an online diary that includes validated questionnaires such as the Tampa Scale for Kinesiophobia (TSK-17) and the Lower Extremity Functional Scale (LEFS).

Standardization Across Sites:

All study procedures will follow a standardized research protocol implemented across multiple orthopedic hospitals and trauma centers in Ukraine to ensure consistency in surgical technique, data collection, and follow-up.

Вмешательства

• Устройство Smart Crutch Tips™
  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.
• Процедура Finite Element Analysis (FEA)
  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), 4 weeks, 8 weeks, and optionally at 12 weeks. Three regions are segmented: fixation system (screws and nail), bone fragments, and fracture gap. Materials: fixator (Titanium Grade 5), bone (m
• Поведенческое Iterative walking
  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™.
• Процедура Lower Limb Rehabilitation Exercise Program
  The program includes isometric and dynamic exercises targeting the quadriceps, hamstrings, gluteal muscles, and ankle/foot mobility to maintain muscle tone, prevent joint stiffness, reduce swelling, and improve circulation. All exercises are performed within a pain-free range (not exceeding 4/10 on the VAS scale) with gradual progression according to the rehabilitation plan.

Первичные конечные точки

• Time to Radiographic Fracture Union [Срок оценки: 12 - 24 weeks post-surgery ± 7 days]

Вторичные конечные точки (6)

• mRUST Score [Срок оценки: at 4, 8, 12, 15, 18, 24, and 36 weeks after surgery (+- 7 days)]
• Adherence to Prescribed Axial Loading [Срок оценки: from 0 to 36 weeks post-surgery]
• Lower Extremity Functional Status (LEFS) [Срок оценки: 0-7 days post-surgery and at 4, 8, 12, 15, 18, 24, 36 weeks after surgery (+- 7 days)]
• Recording of AEs/SAEs AR/SAAR/SUSARs, including Postoperative Complications [Срок оценки: 0-7 days post-surgery and at 4, 8, 12, 15, 18, 24, 36 weeks after surgery (+- 7 days)]
• Pain Level [Срок оценки: At all follow-up visits up to 36 weeks]
• Fear of Movement (TSK-17) [Срок оценки: At all follow-up visits up to 36 weeks]

Критерии участия

Критерии включения

• 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: 41-A2, 41-A3) requiring surgical treatment.
• Fracture treated with a plate 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, 4, 8, 12, 15, 18, 24, and 36 after surgery.
• Stable fractures of the proximal tibia with partial extension of the fracture line into the articular surface are eligible

Критерии исключения

• 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.
• Ongoing or planned use of medications known to affect bone healing.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Украина · 18 центров

• Kyiv City Clinical Hospital No. 1 — Kyiv
• Municipal Clinical Hospital No. 4 of the Dnipro City Counci — Dnipro
• Communal Non-Profit Enterprise "Regional Family Health Medical Center" of the Dnipropetrov — Dnipro
• Municipal Non-Profit Enterprise "City Clinical Hospital No. 16" of the Dnipro City Council — Dnipro
• Municipal Non-Profit Enterprise of the Dnipro Regional Council "Dnipro Regional Clinical H — Dnipro
• University Hospital of the Dnipro State Medical University — Dnipro
• Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Clinical Hospital of the Ivano-F — Ivano-Frankivsk
• Kyiv City Clinical Hospital No. 17 — Kyiv
• … и ещё 10 центров

Идентификаторы

NCT: NCT07134257 · CBM-UA-WB -2025/1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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