[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extra-articular-proximal-tibia-fractures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extra-articular-proximal-tibia-fractures":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100603264","smart-crutch-tips-for-guided-weight-bearing-in-patients-recovering-from-extra-articular-proximal-tibia-fractures-100603264",false,"NCT07134257","Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Proximal Tibia Fractures","Study of Individual Weight-bearing and Iterative Walking Using \"ComeBack Mobility\" Smart Crutch Tips for Mechanical Stimulation of Extra-articular Proximal Tibia Fracture Healing","Inclusion Criteria:\n\n1. Signed informed consent was provided after being fully informed about participation in the study.\n2. Age: 18 to 80 years for both males and females (pre-menopausal).\n3. Body weight between 40 and 120 kg.\n4. Diagnosed with a closed tibial shaft fracture (AO\u002FOTA classification: 41-A2, 41-A3) requiring surgical treatment.\n5. Fracture treated with a plate and\u002For with an intramedullary nail\n6. No diabetes or well-controlled diabetes (HbA1c ≤ 7.0%).\n7. Ability to use crutches without losing balance and medically cleared for partial weight-bearing on the operated limb.\n8. Willingness to adhere to the prescribed weight-bearing protocol using the Smart Crutch Tips™ device.\n9. Enrollment within 48 hours following surgical intervention.\n10. Alcohol consumption (up to 2-3 times per week) within acceptable limits.\n11. Willingness to comply with all study procedures, including follow-up visits at weeks 1, 4, 8, 12, 15, 18, 24, and 36 after surgery.\n12. Stable fractures of the proximal tibia with partial extension of the fracture line into the articular surface are eligible\n\nExclusion Criteria:\n\n1. Presence of open or high-energy fractures, multiple lower-limb fractures, or use of bone grafts.\n2. Fractures classified as 43-B or 43-C according to AO\u002FOTA.\n3. Chronic alcoholism (defined as \\>14 standard drinks per week for men or \\>7 for women).\n4. Presence of metabolic disorders, including uncontrolled thyroid dysfunction, severe renal or hepatic pathology.\n5. Pathological fractures associated with osteoporosis, osteomyelitis, tumors, metastases, or rickets.\n6. Lower-limb contractures with functional impairment of grade II or higher.\n7. Pregnancy or intention to conceive during the study period.\n8. Psychiatric, cognitive, or neurological disorders that may interfere with adherence to the rehabilitation protocol or effective communication with the study team.\n9. Clinically significant heart failure (including chronic or acute, with an ejection fraction \\\u003C40% or with symptoms such as edema, dyspnea at rest, or orthopnea).\n10. Pulmonary insufficiency of any origin, accompanied by chronic hypoxemia (PaO₂ \\\u003C 60 mmHg) or hypercapnia (PaCO₂ \\> 45 mmHg), requiring oxygen support or significantly limiting physical activity.\n11. 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).\n12. Diagnosed epilepsy or other seizure disorders not fully controlled by medication.\n13. Progressive neurodegenerative diseases (e.g., amyotrophic lateral sclerosis, Huntington's disease, dementia).\n14. Any sensory, balance, or vestibular disorders that may impair safe use of the investigational device.\n15. Participation in another clinical study within the past 6 months that could affect the results of the current study.\n16. Ongoing or planned use of medications known to affect bone healing.","ALL","18 Years","80 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nCan 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.\n\nParticipants will:\n\nUse 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.",[27,28,29],"Treatment Duration","Fracture Healing","Extra-articular Proximal Tibia Fractures",[28,31,32,33,34,35,36,37,38,39,40],"Controlled Mechanical Loading","Weight-Bearing","Finite Element Analysis","Bone Union","Digital Rehabilitation","Smart Crutch Tips","Biofeedback Device","Lower Limb Fractures","Rehabilitation Monitoring","extra-articular proximal tibia fractures","RECRUITING","2026-04-11",{"date":44,"type":45},"2026-04-14","ACTUAL",{"date":47,"type":21},"2026-06-20",{"date":49,"type":21},"2027-04-01",{"name":51,"class":52},"Comeback Mobility Inc","INDUSTRY",18]