[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cranioplasty\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cranioplasty":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,75,103,130],{"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":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100628518","simultaneous-vs-staged-vps-and-cp-a-multi-cnter-rct-100628518",false,"NCT07462676","Simultaneous Vs Staged VPS and CP :A Multi-cnter RCT.","A Multicenter, Randomized Trial Comparing Simultaneous and Staged Surgical Management for Ventriculoperitoneal Shunt and Cranioplasty.","Inclusion Criteria:\n\n* 1.Patients who have undergone decompressive craniectomy (DC) for conditions such as Traumatic Brain Injury (TBI), Intracerebral Hemorrhage (ICH), Subarachnoid Hemorrhage (SAH), or Ischemic Stroke (IS), and present with a skull defect concurrent with hydrocephalus. Hydrocephalus must be confirmed by cranial CT\u002FMRI and cerebrospinal fluid pressure measurement.\n\n  2.A definitive diagnosis of hydrocephalus must meet the following criterion: presence of ventriculomegaly (Evans Index \\> 0.3), accompanied by either elevated intracranial pressure (or high bone flap pressure) OR clinical symptoms such as headache, vomiting, or impaired consciousness.\n\n  3.Baseline characteristics: Age between 18 and 70 years, any gender, stable vital signs, and medically fit to tolerate surgery.\n\n  4.Informed consent: The patient or their legal guardian must provide written informed consent.\n\nExclusion Criteria:\n\n1. Patients with a history of prior cranioplasty (CP) or ventriculoperitoneal shunt (VPS) surgery (i.e., re-operation cases).\n2. Patients requiring bilateral cranioplasty.\n3. Patients deemed unsuitable for simultaneous surgery, such as those with excessively bulging or tense bone flaps that preclude safe cranioplasty.\n4. Patients with severe organ failure, coagulation dysfunction, or other systemic conditions that render them unable to tolerate major surgery.\n5. Patients with active intracranial infection, abdominal infection, or systemic infection during the acute phase.\n6. Patients with a known allergy or hypersensitivity to the surgical materials used (e.g., PEEK implants, shunt components).\n7. Pregnant or lactating women.\n8. Patients unable or unwilling to comply with the required follow-up schedule. -","ALL","18 Years","70 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this prospective, multi-center randomized controlled trail is to compare the safety and efficacy of sequential surgery or staged surgery in patients with skull defect and hydrocephalus. The main observation will be the occurrence of complications such as postoperative infection, reoperation, shunt tube obstruction, hematoma, and subdural effusion. This will provide high-quality evidence for clinical selection of appropriate strategies.The concurrent surgery group needs to complete the VPS and CP in the same operation, and the sequence of the surgeries is determined based on the patient's condition and is recorded.However, the staged surgery group requires two surgeries, with an interval of 2 to 8 weeks and the operation order is determined by randomization.Within 1 week after surgery, participants should cooperate to monitor vital signs, assess neurological function ( such as GCS、GOS, etc.), conduct head CT examinations regularly to observe the postoperative intracranial condition, and record the occurrence of postoperative complications.Postoperative follow-up should last for at least 6 months.Outpatient or telephone follow-ups should be conducted at 1 week, 1 month, 3 months, and 6 months after the surgery.During each follow-up, a neurological function assessment and quality of life score (such as the SF-36 Health Survey) should be completed, and the occurrence of postoperative complications should be recorded.",[27,28],"Ventriculoperitoneal Shunt (VPS)","Cranioplasty",[30,31,32,33],"Ventriculoperitoneal Shunt","cranioplasty","Postoperative Complications","Hydrocephalus","NOT_YET_RECRUITING","2026-03-06",{"date":37,"type":38},"2026-03-10","ACTUAL",{"date":40,"type":21},"2026-04-01",{"date":42,"type":21},"2026-11-30",{"name":44,"class":45},"Anhui Provincial Hospital","OTHER_GOV",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":46},"100523604","transcranial-ultrasound-via-sonolucent-cranioplasty-100523604","NCT06097845","Transcranial Ultrasound Via Sonolucent Cranioplasty","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Patients who are undergoing reconstructive sonolucent cranioplasty as standard of care.\n4. Male or female, aged ≥ 18.\n\nExclusion Criteria:\n\n1\\. Patients who are pregnant",{"count":54,"type":21},50,[24],"Transcranial Ultrasound via Sonolucent Cranioplasty is a prospective, single arm, observational, open label (non-blinded) study to collect real world evidence on the use of transcranial ultrasound via sonolucent cranioplasty.",[28,58,59],"Sonolucent Cranioplasty","Reconstructive Cranioplasty",[61,62,63],"Transcranial Ultrasound","SOC ultrasound","PMMA implant","RECRUITING","2025-09-11",{"date":67,"type":38},"2025-09-15",{"date":69,"type":38},"2023-06-27",{"date":71,"type":21},"2028-12-31",{"name":73,"class":74},"Northwell Health","OTHER",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":90,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100600887","evaluation-of-cranial-flap-fixation-with-montage-flowable-settable-bone-paste-100600887","NCT07103330","Evaluation of Cranial Flap Fixation With Montage Flowable Settable Bone Paste","Inclusion Criteria:\n\n1. Male or female \\> 18 years of age\n2. Undergoing a cranial procedure in supratentorial location\n3. Width of craniotomy kerf line \\\u003C3mm for than 75% of the bone flap border\n\nExclusion Criteria:\n\n1. Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells.\n2. Subject has clinically significant hydrocephalus or clinical evidence of altered CSF dynamics.\n3. Subject has undergone a previous, open intracranial neurosurgical procedure in the same anatomical location. (Note: stereotactic biopsy was not exclusionary).\n4. Subject requires a craniectomy (the bone flap is not replaced during the current surgery).\n5. Subject had radiation treatment to the surgical site, or standard fractionated radiation therapy was planned post index-procedure. (Note: stereotactic radiosurgery prior to the planned index procedure was not an exclusion criterion.)\n6. Subject requires a craniotomy across the sinus for which Montage Flowable is applied adjacent to or within the sinus to fixate the cranial flap.\n7. Subject has a condition with anticipated survival shorter than six months.\n8. Subject has undergone chemotherapy treatment, excluding hormonal therapy, within three weeks prior to the planned index procedure, or use of intracavitary chemotherapy wafer (BCNU) was planned, or chemotherapy treatment was planned within two weeks after the index procedure was performed.\n9. Standard use of peri-operative steroids (i.e., corticosteroids) is permitted. Chronic steroid use (defined as daily use of corticosteroids for ≥ 8 weeks) for the purposes of reducing the side effects of chemotherapy and\u002For radiation therapy for cancer is not exclusionary unless the patient is deemed by the investigator to be suffering from steroid toxicity (i.e., Cushing's syndrome) manifested by symptoms and signs such as thin skin, striae, easy bruising, muscle atrophy, upper body obesity, severe fatigue, etc. Use of corticosteroids on a chronic basis (as defined previously) for purposes other than decreasing the symptoms of systemic chemotherapy is exclusionary unless those steroids were discontinued 4 weeks prior to the planned index procedure.\n10. Subject receives warfarin, heparin, other anticoagulant agents on a daily basis and pre-surgical, standard of care drug wash-out did not occur.\n11. Subject is pregnant, breast-feeding, or intended to become pregnant during the course of the study.",{"count":82,"type":21},100,[24],"Montage Flowable Settable Bone Paste is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25cm2. It is also intended to be used for the fixation of cranial bone flaps following craniotomy. The MONTAGE Flowable device comprises two separate components of paste-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together in the applicator tip, the components of the MONTAGE Flowable device form a cohesive paste-like material that adheres to the bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate. The components must be mixed immediately prior to use.",[86,87,88,28,89],"Cranial Bone","Post-operative Complications","Cranial Fixation","Adhesive Bone Cement",[28,91,92],"Settable bone paste","Adhesive cranial cement","2025-07-29",{"date":95,"type":38},"2025-08-05",{"date":97,"type":21},"2026-03",{"date":99,"type":21},"2027-12",{"name":101,"class":102},"Abyrx, Inc.","INDUSTRY",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100573015","risk-factors-for-complications-after-cranioplasty-100573015","NCT06740773","Risk Factors for Complications After Cranioplasty","A Retrospective Study to Identify Risk Factors for Complications After Cranioplasty","Inclusion Criteria:\n\n* Patients who underwent cranioplasty in the Department of Neurosurgery at Qilu Hospital of Shandong University, Tangdu Hospital of Air Force Medical University, or Daping Hospital, Army Military Medical University between January 1, 2015, and July 31, 2023\n* Diagnosed with cranial defects\n* Possessed complete and accessible electronic medical records\n* Patients had no prior history of cranioplasty\n\nExclusion Criteria:\n\n* Patients with a prior history of cranioplasty\n* Severe comorbidities (such as serious cardiac, liver, kidney and immune system dysfunction)\n* Congenital cranial defects\n* Severe missing data",{"count":111,"type":21},1000,"OBSERVATIONAL","Cranial defects often result from brain injuries, hemorrhages, strokes, or brain tumors. These conditions can increase pressure inside the skull, and if left untreated, may lead to dangerous complications like brain herniation. To manage this, a common procedure called decompressive craniectomy is performed to reduce intracranial pressure. While this surgery often stabilizes the patient's condition, it leaves a cranial defect that exposes the brain to external risks, including pressure fluctuations and potential damage. In severe cases, patients with larger defects may develop complications such as sinking skin flap syndrome.\n\nCranial reconstruction, also known as cranioplasty, is an important procedure to restore the skull's structure and protect the brain. This surgery can improve brain function, stabilize intracranial pressure, and enhance the patient's appearance. While cranioplasty is a standard neurosurgical procedure, it has a relatively high risk of complications compared to other brain surgeries. Common complications include infections, bleeding, hydrocephalus, and seizures. In severe cases, complications may lead to the failure of the reconstruction.\n\nUnderstanding the factors that contribute to complications after cranioplasty is crucial for neurosurgeons to improve outcomes and reduce risks. This study aims to identify these factors and develop predictive models for postoperative complications of cranioplasty.",[28,32,115],"Risk Assessment",[28,32,117,118,119],"Risk factors","Retrospective Study","predictive model","2025-06-02",{"date":122,"type":38},"2025-06-05",{"date":124,"type":38},"2024-12-17",{"date":126,"type":21},"2025-12-31",{"name":128,"class":74},"Qilu Hospital of Shandong University",3,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":141,"conditions":142,"keywords":145,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":46},"100567032","phase-2-cranioplasty-using-titanium-mesh-vs-bone-cement-100567032","NCT06662903","Cranioplasty Using Titanium Mesh vs Bone Cement","A Comparative Study Between Cranioplasty Using Titanium Mesh vs Bone Cement","* Inclusion Criteria:\n\n  * Patients requiring cranioplasty for a skull defect due to Decompressive Craniectomy, trauma, tumor resection, or congenital issues.\n  * All ages .\n  * Both sex.\n  * Informed consent obtained from all participants.\n  * Patient fit for surgery.\n* Exclusion Criteria:\n\n  * Patients with active infection at the surgical site\n  * Patient Unfit for surgery.\n  * Patient refuse consent",{"count":138,"type":21},46,[140],"PHASE2","The aim of this study is:\n\nTo compare the surgical outcomes between titanium mesh and bone cement in cranioplasty.\n\nTo assess the complication rates associated with each material. To evaluate patient satisfaction and aesthetic results post-surgery",[143,144,28],"Bone Defects","Decompressive Craniectomy and Cranioplasty",[28,146,147,148],"Titanium mesh","Bone cement","Traumatic brain injury","2024-10-25",{"date":151,"type":38},"2024-10-29",{"date":153,"type":21},"2024-10",{"date":155,"type":21},"2026-05",{"name":157,"class":74},"Osman Hassan Osman Zafraan"]