Overview
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.
Description
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 distal tibia fractures. The study will enroll 30 adult participants (aged 18-60) with closed distal tibia fractures (AO/OTA 43- А1, 43-А2, 43-А3) treated with plates. Participants will be allocated into three parallel groups (ten participants per group).
Group 1 - Control (Standard Practice):
During the first six to ten 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 10-20 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 0-7) and then at 6, 12, 15, 18, 21, 24, and 36 weeks post-surgery. At each follow-up visit starting from Visit 1 (6 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 (6 weeks), Visit 2 (12 weeks), and optionally prior to Visit 3 (15 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.
Eligibility
Inclusion Criteria:
- Signed informed consent was provided after being fully informed about participation in the study.
- Age: 18 to 60 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
- 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.
Exclusion Criteria:
- 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.
- Ongoing or planned use of medications known to affect bone healing.