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
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Comeback Mobility Inc
- Enrollment
- 30
- Locations
- 28
- Primary Endpoint
- Time to Radiographic Fracture Union
Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Data analysts, FEA specialists and radiologists will also be blinded to group allocation until the database lock
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Arms & Interventions
Control Group (Standard of Care)
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
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.
Intervention: Smart Crutch Tips™ (Device)
Controlled Mechanical Stimulation According to AO Guidelines
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.
Intervention: Orthopedic shoes for use during rehabilitation period (Device)
Personalized Controlled Mechanical Stimulation (FEA)
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.
Intervention: Finite Element Analysis (FEA) (Procedure)
Controlled Mechanical Stimulation According to AO Guidelines
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.
Intervention: Finite Element Analysis (FEA) (Procedure)
Personalized Controlled Mechanical Stimulation (FEA)
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.
Intervention: Smart Crutch Tips™ (Device)
Personalized Controlled Mechanical Stimulation (FEA)
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.
Intervention: Iterative walking (Behavioral)
Personalized Controlled Mechanical Stimulation (FEA)
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.
Intervention: Lower Limb Rehabilitation Exercise Program (Procedure)
Personalized Controlled Mechanical Stimulation (FEA)
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.
Intervention: Orthopedic shoes for use during rehabilitation period (Device)
Outcomes
Primary Outcomes
Time to Radiographic Fracture Union
Time Frame: 12 - 24 weeks post-surgery ± 7 days
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.
Time to Radiographic Fracture Union
Time Frame: 12 - 24 weeks post-surgery ± 7 days
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.
Secondary Outcomes
- 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))
- Fear of Movement (TSK-17)(0-8 days post-surgery and at 6, 12, 15, 18, 21, 24, 36 weeks after surgery (+- 7 days))
- 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)(0-7 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(0-7 days post-surgery and at 6, 12, 15, 18, 21, 24, 36 weeks after surgery (+- 7 days))
- Pain Level(0-7 days post-surgery and at 6, 12, 15, 18, 21, 24, 36 weeks after surgery (+- 7 days))
- Fear of Movement (TSK-17)(0-7 days post-surgery and at 6, 12, 15, 18, 21, 24, 36 weeks after surgery (+- 7 days))