Study of Individual Weight-bearing and Iterative Walking Using "ComeBack Mobility" Smart Crutch Tips for Mechanical Stimulation of Extra-articular Proximal Tibia Fracture Healing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 28
- 主要终点
- Time to Radiographic Fracture Union
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data analysts, FEA specialists and radiologists will also be blinded to group allocation until the database lock
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Controlled Mechanical Stimulation According to AO Guidelines
Participants in this group receive recommendations for weight-bearing progression in accordance with AO guidelines (10-15 kg load). Axial loading is monitored in real time using Smart Crutch Tips™, which provide visual and auditory feedback.
干预措施: 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.
干预措施: Iterative walking (Behavioral)
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 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 (10-15 kg load). Axial loading is monitored in real time using Smart Crutch Tips™, which provide visual and auditory feedback.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: Lower Limb Rehabilitation Exercise Program (Procedure)
结局指标
主要结局
Time to Radiographic Fracture Union
时间窗: 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 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.
Time to Radiographic Fracture Union
时间窗: 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 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.
次要结局
- mRUST Score(at 4, 8, 12, 15, 18, 24, and 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 4, 8, 12, 15, 18, 24, 36 weeks after surgery (+- 7 days))
- Recording of AEs/SAEs AR/SAAR/SUSARs, including Postoperative Complications(0-7 days post-surgery and at 4, 8, 12, 15, 18, 24, 36 weeks after surgery (+- 7 days))
- Pain Level(At all follow-up visits up to 36 weeks)
- Fear of Movement (TSK-17)(At all follow-up visits up to 36 weeks)
- Fear of Movement (TSK-17)(At all follow-up visits up to 36 weeks)
- Adherence to Prescribed Axial Loading(from 0 to 36 weeks post-surgery)
- Lower Extremity Functional Status (LEFS)(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(0-7 days post-surgery and at 4, 8, 12, 15, 18, 24, 36 weeks after surgery (+- 7 days))
- Pain Level(At all follow-up visits up to 36 weeks)