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

Official title

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

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.

Detailed 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 18-80) with closed distal tibia fractures (AO/OTA 43- А1, 43-А2, 43-А3) 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 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.

Interventions

• Device 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.
• Procedure 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), 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 co
• Behavioral 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.
• Procedure Lower Limb Rehabilitation Exercise Program
  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
• Device Orthopedic shoes for use during rehabilitation period
  Patients are provided with orthopedic shoes to be worn during the rehabilitation period (up to 6-10 weeks).

Primary outcome measures

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

Secondary outcome measures (6)

• mRUST Score [Time frame: at 6, 12, 15, 18, 21, 24, 36 weeks after surgery (+- 7 days)]
• Adherence to Prescribed Axial Loading [Time frame: from 0 to 36 weeks post-surgery]
• Lower Extremity Functional Status (LEFS) [Time frame: 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 [Time frame: 0-8 days post-surgery and at 6, 12, 15, 18, 21, 24, 36 weeks after surgery (+- 7 days)]
• Pain Level [Time frame: 0-8 days post-surgery and at 6, 12, 15, 18, 21, 24, 36 weeks after surgery (+- 7 days)]
• Fear of Movement (TSK-17) [Time frame: 0-8 days post-surgery and at 6, 12, 15, 18, 21, 24, 36 weeks after surgery (+- 7 days)]

Eligibility criteria

Inclusion criteria

• 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."

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Ukraine · 18 centers

• 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
• … and 10 more centers

Identifiers

NCT: NCT07138066 · CBM-UA-WB -2025/2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗