Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures

Not Applicable

Recruiting

• Conditions: Tibial Fractures; Fracture Healing

• Registration Number: NCT07092579
• Lead Sponsor: Comeback Mobility Inc

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 tibial shaft 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? Does iterative walking in the early postoperative period support faster or better bone healing? Researchers will compare standard rehabilitation to different types of personalized weight-bearing programs to see which 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 six 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 individual weight-bearing and iterative walking regimens on the healing of tibial shaft fractures. The study will enroll 30 adult participants (aged 18 to 60) with closed tibial shaft fractures (AO/OTA 42-A, 42-B, or 42-C) treated by intramedullary nailing. Participants will be allocated into three parallel groups (ten participants per group), two of whom will receive personalized weight-bearing protocols based on finite element analysis (FEA) performed using individual CT scan data.

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

Group 1 (control - standard practice) will use Smart Crutch Tips™ for load data collection only, without feedback, and follow AO Foundation guidelines, progressing weight-bearing based on pain tolerance.

Group 2 (controlled mechanical stimulation) will receive personalized FEA-based load prescriptions for optimal interfragmentary motion, with real-time audio/visual feedback from Smart Crutch Tips™. They will perform iterative walking sessions (minimum two-hour rest between), gradually increasing steps per their plan, plus prescribed lower limb strengthening exercises.

Group 3 (optimized stimulation per Claes-Heigele theory) will receive FEA-based prescriptions targeting maximum fracture-zone voxel optimization, with real-time feedback. They will follow the same walking and exercise protocol as Group 2.

Participants will use ComeBack Mobility Smart Crutch Tips™ all the time 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 seven in-person follow-up visits: screening (Day 0-7), and then at 6, 12, 16, 20, 24, and 36 weeks after surgery. Аt 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 only 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 optional prior to Visit 3 (16 weeks) to adjust weight-bearing prescription and assess consolidation dynamics. 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 (LEFS). At Visit 1, participants will also complete the System Usability Scale (SUS) to assess their experience using the device.

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

Study Timeline

• Study First Submitted: 2025-07-16
• Study First Submitted QC: 2025-07-23
• Study First Posted: 2025-07-30
• Status Verified: 2025-08
• Last Update Submitted: 2025-09-29
• Last Update Posted: 2025-10-01
• Study Start: 2025-10-20
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Signed informed consent was provided after being fully informed about participation in the study.
2. Age: 18 to 60 years for both males and females (pre-menopausal).
3. Body weight between 40 and 120 kg.
4. Body Mass Index (BMI) between 18.5 and 29.9 kg/m².
5. Diagnosed with a closed tibial shaft fracture (AO/OTA classification: 42-A, 42-B, or 42-C) requiring surgical treatment.
6. Fracture treated exclusively with intramedullary nailing (intramedullary fixation without additional plates or external fixation).
7. No diabetes or well-controlled diabetes (HbA1c ≤ 7.0%).
8. Ability to use crutches without losing balance and medically cleared for partial weight-bearing on the operated limb.
9. Willingness to adhere to the prescribed weight-bearing protocol using the Smart Crutch Tips™ device.
10. Enrollment within 48 hours following surgical intervention.
11. Alcohol consumption (up to 2-3 times per week) within acceptable limits.
12. Willingness to comply with all study procedures, including follow-up visits at weeks 1, 6, 12, 16, 20, 24 and 36 after surgery.

Exclusion Criteria

1. Presence of open or high-energy fractures, multiple lower-limb fractures, or use of bone grafts.
2. Fractures classified as 43-B or 43-C according to AO/OTA.
3. Chronic alcoholism (defined as >14 standard drinks per week for men or >7 for women).
4. Presence of metabolic disorders, including uncontrolled thyroid dysfunction, severe renal or hepatic pathology.
5. Pathological fractures associated with osteoporosis, osteomyelitis, tumors, metastases, or rickets.
6. Lower-limb contractures with functional impairment of grade II or higher.
7. Pregnancy or intention to conceive during the study period.
8. Psychiatric, cognitive, or neurological disorders that may interfere with adherence to the rehabilitation protocol or effective communication with the study team.
9. Clinically significant heart failure (including chronic or acute, with an ejection fraction <40% or with symptoms such as edema, dyspnea at rest, or orthopnea).
10. 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.
11. 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).
12. Diagnosed epilepsy or other seizure disorders not fully controlled by medication.
13. Progressive neurodegenerative diseases (e.g., amyotrophic lateral sclerosis, Huntington's disease, dementia).
14. Any sensory, balance, or vestibular disorders that may impair safe use of the investigational device.
15. Participation in another clinical study within the past 6 months that could affect the results of the current study.
16. Ongoing or planned use of medications known to affect bone healing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to Radiographic Fracture Union	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 postoperatively. CT will be conducted at Visit 0, Visit 1, Visit 2, and optionally at 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 Outcome Measures

Name	Time	Method
mRUST Score	at 6, 12, 16, 20, 24, and 36 weeks after surgery (+- 7 days)	The modified Radiographic Union Scale for Tibial fractures (mRUST) is used to assess bone healing based on radiographs of the fracture site. Four cortices are evaluated, with scores assigned according to callus formation and visibility of the fracture line. The total score ranges from 4 to 16, with higher scores indicating more advanced bone healing. mRUST scores will be compared between intervention and control groups at each follow-up visit to determine the impact of the intervention on bone healing.
Adherence to Prescribed Axial Loading	from 0 to 36 weeks post-surgery	The percentage of steps taken within the prescribed range of axial loading. Higher percentages indicate better adherence to the prescribed loading regimen. This is measured through continuous monitoring using the Smart Crutch Tips™ device and analyzed at each follow-up visit (from 0 to 36 weeks).
Lower Extremity Functional Status (LEFS)	0-7 days post-surgery and at 6, 12, 16, 20, 24, 36 weeks after surgery (+- 7 days)	Assessed using the Lower Extremity Functional Scale (LEFS) - a validated instrument designed to measure a patient's ability to perform everyday physical activities involving the lower limbs. The questionnaire consists of 20 items, each scored from 0 (extreme difficulty or unable to perform) to 4 (no difficulty). The total score ranges from 0 to 80, with higher scores indicating better functional status.
Recording of AEs/SAEs AR/SAAR/SUSARs, including Postoperative Complications	0-7 days post-surgery and at 6, 12, 16, 20, 24, 36 weeks after surgery (+- 7 days)	The following types of postoperative complications will be recorded and analyzed: residual pain; delayed union; nonunion; malunion; implant failure; need for reoperation. Assessment will be performed clinically at each visit and supplemented with radiological evaluation (X-ray and CT), according to the visit schedule.; All adverse events (AEs), serious adverse events (SAEs), adverse reactions (ARs), serious adverse reactions (SAARs), and suspected unexpected serious adverse reactions (SUSARs) identified during the study will also be recorded, described, and analyzed.
Pain Level	0-7 days post-surgery and at 6, 12, 16, 20, 24, 36 weeks after surgery (+- 7 days)	Assessed using the Visual Analogue Scale (VAS), presented electronically as a continuous line ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity. Assessment is conducted at each follow-up visit
Fear of Movement (TSK-17)	0-7 days post-surgery and at 6, 12, 16, 20, 24, 36 weeks after surgery (+- 7 days)	Assessed using the Tampa Scale for Kinesiophobia, 17-item version (TSK-17), which evaluates fear of physical activity due to pain or risk of re-injury. Scores range from 17 to 68, with higher scores indicating greater fear of movement. Administered electronically at each follow-up visit.

Trial Locations

Locations (12)

Kyiv City Clinical Hospital No. 1; 🇺🇦 Kyiv, Kyiv Oblast, Ukraine

Municipal Clinical Hospital No. 6 of the Dnipro City Counci; 🇺🇦 Dnipro, Ukraine

Municipal Clinical Hospital No. 4 of the Dnipro City Counci; 🇺🇦 Dnipro, Ukraine

Railway Clinical Hospital No. 1 of Kyiv Station; 🇺🇦 Kyiv, Ukraine

Kyiv City Clinical Hospital No. 17; 🇺🇦 Kyiv, Ukraine

Institute of Traumatology and orthopedics of the national academy of medical sciences of Ukraine; 🇺🇦 Kyiv, Ukraine

Kyiv City Clinical Hospital No. 12; 🇺🇦 Kyiv, Ukraine

Kyiv City Clinical Hospital No. 6; 🇺🇦 Kyiv, Ukraine

Kyiv City Clinical Hospital No. 7; 🇺🇦 Kyiv, Ukraine

Kyiv Regional Council "Kyiv Regional Clinical Hospital"; 🇺🇦 Kyiv, Ukraine

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