[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tibia-fractures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tibia-fractures":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100607820","assessment-of-the-feasibility-of-using-a-preoperative-surgical-fracture-analysis-tool-100607820",false,"NCT07193524","Assessment of the Feasibility of Using a Preoperative Surgical Fracture Analysis Tool","Inclusion Criteria:\n\n* Age above 18\n* lower extremity fracture","ALL","18 Years",{"count":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22],"NA","This study aims to evaluate a preoperative fracture analysis tool that uses 3D visualization and biomechanical modeling to assist surgeons in planning screw and plate fixation for complex tibial plateau fractures. By simulating different fixation strategies based on patient-specific CT data, the tool provides insights into construct stability, potentially improving surgical precision and reducing intraoperative uncertainty. The study also investigates the tool's feasibility within current clinical workflows without altering the standard of care.",[25,26,27],"Tibia Fractures","Trauma (Including Fractures)","Surgical Planning",[29,30,27,31],"3D","Tibia fracture","Fracture Analysis","RECRUITING","2025-09-24",{"date":35,"type":36},"2025-09-26","ACTUAL",{"date":38,"type":36},"2025-09-10",{"date":40,"type":19},"2028-09",{"name":42,"class":43},"Brigham and Women's Hospital","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":55,"briefSummary":56,"conditions":57,"keywords":63,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100604729","assessing-bone-fracture-healing-effect-of-almonds-100604729","NCT07153302","Assessing Bone Fracture Healing Effect of Almonds","Assessing Bone Fracture Healing Effect of Prunus Dulcis (Almonds) - A Randomized Controlled Trial","AFHEA","Inclusion Criteria:\n\n1. Patients of 18 to 55 years of age of any gender.\n2. Agree and able to voluntary participate.\n3. Patients with trauma associated femur fracture and tibia shaft fracture arriving at hospital for treatment.\n\nExclusion Criteria:\n\n1. Mentally retarded or patients with severe psychiatric illness.\n2. Patients are already on bone-strengthening drugs (bisphosphonates, vitamin D, strontium ranelate, teriparatide, etc.).\n3. Patients who require bone-strengthening drugs for osteoporosis or for any urgent need.\n4. Severe cardiovascular, hepatic, or renal disease.\n5. Known allergy or toxicity to Prunus dulcis (almonds) and\u002For vitamin D supplements.","55 Years",{"count":54,"type":19},136,[22],"Femur and tibia shaft fractures are common after trauma with a burden of 5% and 20% respectively. Clinicians recommend costly bone strengthening drugs\u002Fsupplements while treating bone fractures. These drugs have side effects and are costly due to which patients skip these supplements. Routinely prescribed vitamin D have known toxicity. To overcome this problem, affordable and safe alternative treatment is needed. Sweet almonds contain essential bone nutrients that might have potential for maintaining bone strength. Human and animal studies have shown positive impact of almonds on bone health and fracture healing. Almonds are consumed in diet frequently but may occasionally cause toxicity, mainly if consumed at higher amount. Because of the high bone essential nutrients in almonds, the trial aimed to investigate the fracture healing effect and safety of almonds in femur and tibia shaft fractures. This might provide an alternate option for bone supplants while treating fractures.\n\nHypothesis: Compared to routine vitamin D3, almonds non-inferiorly improves fracture callus index and raise vitamin D3 level in blood in femur and tibia shaft fracture patients.\n\nPrimary Objectives:\n\n1. To compare tibia and femur shaft fracture callus index and callus bridging on x-rays at 4 and 13 weeks herewith group 1 suffering vitamin D insufficiency (arm A versus arm B) and group 2 suffering vitamin D deficiency (arm B versus arm C) treated as cross-over with oral whole almonds and vitamin D3.\n2. To compare the incidence of adverse events between almonds and vitamin D3 treatments up to 13 weeks follow-up.\n\nSecondary Objectives:\n\n1. To compare the almonds and vitamin D3 treatment cost.\n2. To compare within group blood vitamin D levels (ng\u002FmL) at baseline and post-treatment follow-ups.\n\nMethods:\n\nStudy design: Single-center, open-labeled, crossover, non-inferiority randomized controlled trial.\n\nTotal 136 subjects are required with 14 subjects in group 1 and 122 in group 2.in 24-month duration.\n\nStudy procedures:\n\n1. Regulatory and Ethical approvals.\n2. Patient screening and eligibility assessment. Patients, of 18 to 55 years of age of any gender, with trauma associated femur and tibia shaft fractures who agree to voluntary participate are included and mentally retarded or patients with severe psychiatric illness, already on or require bone-strengthening drugs , having severe cardiovascular, hepatic, or renal disease, known allergy\u002Ftoxicity to almonds and\u002For vitamin D supplements.\n3. Written informed consent administration.\n4. Randomization Patients (N=136) are divided into two groups. Group 1 (N=14, vitamin D insufficiency, blood vitamin D level 21-29 ng\u002FmL) and Group 2 (N=122, vitamin D deficiency, blood vitamin D level ≤20 ng\u002FmL).\n\n   I. Group 1 (N=14):\n\n   Arm A (n=7)=5 grams\u002Fday of almonds for 4 weeks, followed by 7 days washout period and cross-over treatment by oral vitamin D3 200,000 units\u002Fweek for 8 weeks.\n\n   Arm B (n=7)=Oral vitamin D3 200,000 units\u002Fweek for 8 weeks, followed by 7 days washout period and cross-over treatment by 5 grams\u002Fday of almonds for 4 weeks\n\n   II. Group 2 (N=122):\n\n   Arm B (n=61)=Oral vitamin D3 200,000 units\u002Fweek for 8 weeks, followed by 7 days washout period and cross-over treatment by 5 grams\u002Fday of almonds for 4 weeks.\n\n   Arm C (n=61)=Oral vitamin D3 200,000 units\u002Fweek together with 5 grams\u002Fday almonds for 4 weeks, followed by 7 days washout period and cross-over treatment by oral vitamin D3 200,000 units\u002Fweek for 8 weeks.\n5. Patients are followed at 4 weeks and 13 weeks follow-ups after treatment.\n6. Fracture site routine X-rays and RUST scores are assessed by treating surgeon\u002Finvestigator(s) at follow-ups for bone fracture healing.\n7. Investigational product (IP) safety assessment and reporting as per ICH-GCP guidelines. Subjects experiencing any adverse event (AE)\u002Fserious adverse event (SAE) is provided optimum care at earliest. All relevant reporting bodies are notified within recommended timeline.\n8. The almonds are regularly purchased from the Purchase Department of the Hospital, weighted, packaged and labelled, and stored at the secure dry hygienic place. The product is dispensed to the patient and a daily IP diary is provided for compliance.\n9. Patients can withdraw from the study at any time without losing any of his\u002Fher patient rights.\n10. Study close-out process will be of one to two-month duration.\n\nStatistical analysis:\n\nThe SPSS version 19.0 will be used to analyze data. Quantitative variables will be expressed as mean±SD\u002Fmedian (IQR) and qualitative as frequencies (%). IP related AEs\u002FSAEs will be assessed by incidence\u002Fstratification. Witin group and within arm comparisons for the radiological assessments and vitamin D3 level will be analyzed by ANOVA and GEE. Within arm tibia and femur fracture outcomes will be compared by independent t-test\u002FMann Whitney U test. The p-value \\\u003C0.05 is considered significant. Multiple regression analysis for association of covariates and outcome will be used.",[58,25,59,60,61,62],"Femur Shaft Fracture","Vitamin D","Sweet Almonds","Callus Index","Callus Bridging",[64,65,66,67,68,69],"callus bridging","callus index","femur shaft fracture","tibia shaft fracture","Prunus dulcis (almonds)","vitamin D3","2025-08-30",{"date":72,"type":36},"2025-09-03",{"date":74,"type":36},"2024-08-20",{"date":76,"type":19},"2026-07",{"name":78,"class":43},"Aga Khan University Hospital, Pakistan",1]