[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"distal-tibia-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:distal-tibia-fracture":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"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},"100603557","smart-crutch-tips-for-guided-weight-bearing-in-patients-recovering-from-extra-articular-distal-tibia-fractures-100603557",false,"NCT07138066","Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures","Study of Individual Weight-bearing and Iterative Walking Using \"ComeBack Mobility\" Smart Crutch Tips for Mechanical Stimulation of Extra-articular Distal 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: 43- А1, 43-А2, 43-А3) requiring surgical treatment.\n5. Fracture treated exclusively with plates 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, 6, 12, 15, 18, 21, 24, and 36 after surgery.\n12. Patients with fractures extending into the articular surface of the distal tibial epiphysis may be included, provided that the fracture is deemed stable.\"\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 41-A, 41-B, or 42 -A,B 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 distal 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],"Fracture Healing","Treatment Duration","Distal Tibia Fracture",[31,27,32,33,34,35,36,37,38,39,40],"distal tibia fracture","Controlled Mechanical Loading","Weight-Bearing","Finite Element Analysis","Digital Rehabilitation","Smart Crutch Tips","Bone Union","Rehabilitation Monitoring","Lower Limb Fractures","Biofeedback Device","RECRUITING","2026-04-11",{"date":44,"type":45},"2026-04-14","ACTUAL",{"date":47,"type":45},"2025-09-29",{"date":49,"type":21},"2027-01-15",{"name":51,"class":52},"Comeback Mobility Inc","INDUSTRY",18,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":76,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":96},"100566684","prospective-validation-study-of-the-cd8temra-cells-as-a-prognostic-biomarker-of-healing-outcome-after-fracture-100566684","NCT06658379","Prospective Validation Study of the CD8+TEMRA Cells As a Prognostic Biomarker of Healing Outcome After Fracture","BioBone","Inclusion Criteria:\n\n* male or female subjects\n* subjects \\> 18 to 80 years of age at the time of screening\n* closed fractures\n* fractures of the humerus-shaft, forearm-shaft, femur and tibia\n* Subjects suffering monotrauma or comparable with monotrauma, due to comparable post-surgery mobilisation\n* osteosynthesis\n* subject has signed an informed consent form\n* legal capacity\n\nExclusion Criteria:\n\n* cancer related fractures\n* periprosthetic fractures\n* known active Hepatitis B virus or Hepatitis C virus infection at screening\n* known human immunodeficiency virus (HIV) infection, severe uncontrolled inflammatory disease or severe uncontrolled autoimmune disease (e.g., ulcerative colitis, Crohn's disease\n* active malignancy or history of malignancy within 5 years prior to screening\n* known diagnosis of moderate to severe dementia based on subject's medical history or severe psychiatric disorder\n* known history of drug or alcohol abuse in the past 12 months, based on self-report or medical record\n* history of autologous\u002Fallogeneic bone marrow (BM) or solid organ transplantation\n* exposure to allogeneic cell-based therapy in the past or exposure to autologous cell therapy in the last 12 months before screening\n* pregnancy\n* subject is currently enrolled in an investigational device or drug trial, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s).\n* subject is detained or institutionalized under a court order or administrative order\n* in the opinion of the investigator, the subject is unsuitable for participating in the study (patient compliance).",{"count":62,"type":21},640,"OBSERVATIONAL","In approx. 10-15% of all fracture patients, there is a prolonged healing time or even a complete absence of fracture healing (non-union). As a result, these patients require further surgical interventions, combined with renewed or prolonged hospitalisation\u002Frehabilitation and incapacity to work. To summarise, this therefore represents a serious socio-economic problem. At present, there is no prognostic method for the early prediction of patients at risk of a disturbed healing process. However, if these patients are successfully stratified, there are already a variety of therapeutic strategies available to additionally stimulate fracture healing. Therefore, the aim is to conduct a prospective clinical study to validate CD8+ TEMRA cells as a prognostic marker of impaired fracture healing. The investigators assume that preoperative CD8+ TEMRA cell expression represents a prognostic biomarker with high diagnostic precision for differentiating between a) normal healing patients, b) delayed healing patients and c) pseudarthrosis patients. Furthermore, the sensitivity and specificity should be high enough, health-economically significant and realisable in clinical routine.",[66,27,67,68,69,70,71,72,73,74,75,29],"Fracture Non Union","Long Bone Delayed-Union Fracture","Humerus Shaft Fracture","Forearm Fracture","Femoral Neck Fractures","Femur Distal Fracture","Pertrochanteric Fracture of Femur","Femoral Shaft Fracture","Proximal Tibia Fracture","Tibial Shaft Fracture",[77,78,79,80,81,82,83,84,85],"long bone fracture","impaired fracture healing","fracture non-union","prognosis","prognostic biomarker","Immune system","T cells","radiology","bone fracture healing","2024-10-23",{"date":88,"type":45},"2024-10-26",{"date":90,"type":45},"2016-12",{"date":92,"type":21},"2025-06",{"name":94,"class":95},"Charite University, Berlin, Germany","OTHER",7]