[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"RevBio\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,38,57],{"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":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":4},"100627738","a-pilot-clinical-study-to-evidence-safety-and-efficacy-of-fracture-fixation-of-the-distal-radius-using-a-bioresorbable-bone-adhesive-to-augment-metal-hardware-100627738",false,"NCT07452536","A Pilot Clinical Study to Evidence Safety and Efficacy of Fracture Fixation of the Distal Radius Using a Bioresorbable Bone Adhesive to Augment Metal Hardware","Inclusion Criteria:\n\n* Unilateral, unstable and\u002For displaced distal radius AO\u002FOTA type 2R3C fracture.\n* Standard treatment would consist of open reduction internal fixation (ORIF) with plate(s) and screws using a volar approach\n* Surgical visit occurs within 2 weeks of injury.\n* No radiographic evidence of fracture healing prior to surgical treatment.\n* Male or female, greater than 21 years of age\n* Subject living independently and ambulatory at the time of injury.\n* Subject, and\u002For subject's representatives are able and willing to provide informed consent and HIPAA authorization.\n* Subject able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.\n\nIntra-Operative Inclusion Criteria:\n\n* No sign of active infection at the planned operative site.\n* Surgeons will decide whether the fracture site is a good candidate for TN-MFF use once the site is open and they can visualize the bone and surrounding soft tissue.\n\nExclusion Criteria:\n\n* Significant ligamentous disruption requiring independent repair\n* Other fractures of the carpal bones or injured limb (Note: an associated ulnar styloid fracture is not exclusionary)\n* Pathological fracture related to an underlying malignancy\n* Open fractures\n* A previous fracture in the injured bone within the last 12 months\n* Presence of other orthopaedic implant in the injured bone\n* Patients with presumptive diagnosis of named nerve or blood vessel injury\n* Current infection (either superficial or deep) at the planned operative site\n* Sepsis within one week from the planned index procedure\n* History of radiotherapy to the area\n* Active chemotherapy treatment\n* Patients receiving treatment with biologics for systemic inflammatory disease (e.g., Enbrel)\n* Physically or mentally compromised and unable to provide consent or perform functional examinations\n* Subject has a condition with anticipated survival shorter than 12 months","ALL","21 Years",{"count":18,"type":19},20,"ESTIMATED","INTERVENTIONAL",[22],"NA","A prospective, multi-center (up to 4 sites), single-arm, study of 20 subjects. Patient enrollment will consist of subjects with an AO\u002FOTA type 2R3C distal radius fracture. Enrollment will be prospectively stratified based on patient age (Stratum A: \\\u003C65 and Stratum B: ≥65 years)",[25],"AO\u002FOTA Type 2R3C Distal Radius Fracture","NOT_YET_RECRUITING","2026-03-02",{"date":29,"type":30},"2026-03-05","ACTUAL",{"date":32,"type":19},"2026-04-15",{"date":34,"type":19},"2027-06-15",{"name":36,"class":37},"RevBio","INDUSTRY",{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":4,"eligibilityCriteria":43,"healthyVolunteers":11,"sex":15,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":4,"studyType":20,"phases":48,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":52,"startDateStruct":53,"completionDateStruct":54,"leadSponsor":56,"locationsCount":4},"100627739","safety-and-effectiveness-of-tetranite-bone-adhesive-for-cranial-flap-fixation-compared-to-traditional-metal-hardware-100627739","NCT07452549","Safety and Effectiveness of TETRANITE Bone Adhesive for Cranial Flap Fixation Compared to Traditional Metal Hardware","Inclusion Criteria:\n\n* Subject, and\u002For subject's family are able and willing to provide informed consent and HIPAA authorization prior to any study related procedures.\n\n  * Subjects can be any gender, but be between (and including) 18 and 80 years of age\n  * Subject is scheduled for a cranial procedure that requires the creation of a bone flap or replacement of a bone flap (i.e., cranioplasty)\n  * Subject is scheduled for a cranial procedure in the supratentorial location.\n  * Subject is able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.\n  * Pre-operative CT scan for craniotomy patients must be less than or equal to 0.625 mm slice thickness and pixel spacing. It shall include the skull in native condition near the planned flap site DICOM export must be thin sliced reconstruction in the bone window.\n\nIntra-Operative Inclusion Criteria:\n\n• Width of craniotomy kerf line \\\u003C 3mm for more than 75% of the bone flap border.\n\nExclusion Criteria:\n\n* Subject has undergone a previous, open intracranial neurosurgical procedure in the same anatomical location. (Note: stereotactic biopsy is not exclusionary).\n\n  * Subject requires a craniectomy (the bone flap is not replaced during the current surgery).\n  * Subject has had radiation treatment to the surgical site within the past year, or standard fractionated radiation therapy was planned within 2 weeks post index-procedure. (Note: stereotactic radiosurgery prior to the planned index procedure was not an exclusion criterion.)\n  * Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells. Note: Superficial penetration of mastoid air cells is not an exclusion if cells were appropriately sealed (e.g., bone wax).\n  * Subject has clinically significant hydrocephalus or clinical evidence of altered CSF dynamics. 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.\n  * 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.\n  * Subject has a condition with anticipated survival shorter than one year.\n  * Subject receives warfarin, heparin, other anticoagulant agents on a daily basis and pre-surgical, standard of care drug wash-out did not occur.\n  * Subject is pregnant, breast-feeding, or intended to become pregnant during the course of the study.\n  * Current infection (either superficial or deep) at the planned operative site\n  * Sepsis diagnosed within one week before the planned index procedure","18 Years","80 Years",{"count":47,"type":19},204,[22],"The aim of this study is to demonstrate the safety and efficacy of TETRANITE, a bioresorbable bone adhesive, for Cranial Flap Fixation as compared to traditional metal hardware.",[51],"Craniotomy",{"date":29,"type":30},{"date":32,"type":19},{"date":55,"type":19},"2027-12-15",{"name":36,"class":37},{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":15,"minAge":44,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":20,"phases":67,"briefSummary":68,"conditions":69,"keywords":70,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100576097","a-pilot-clinical-study-to-evidence-improved-cranial-flap-fixation-with-a-bioresorbable-bone-adhesive-100576097","NCT06780852","A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive","A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive Based on Imaging and Patient Reported Outcomes","Inclusion Criteria:\n\nSubjects or representatives must have voluntarily signed the informed consent form before any study related procedures;\n\n* Subjects can be any gender, but be between (and including) 18 and 75 years of age\n* Subject is scheduled for a cranial procedure in the supratentorial location.\n* Subject requires a procedure involving a Class I\u002Fclean wound (uninfected surgical wound in which no inflammation was encountered).\n* Subject, and\u002For subject's family are able and willing to provide informed consent and HIPAA authorization.\n* Subject is able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.\n\nIntra-Operative Inclusion Criteria:\n\n* Width of craniotomy kerf line \\\u003C 3mm for more than 75% of the bone flap border\n\nExclusion Criteria:\n\n* Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells. Note: Superficial penetration of mastoid air cells is not an exclusion if cells were appropriately sealed (e.g., bone wax).\n* Subject has clinically significant hydrocephalus or clinical evidence of altered CSF dynamics.\n* Subject has undergone a previous, open intracranial neurosurgical procedure in the same anatomical location. (Note: stereotactic biopsy was not exclusionary).\n* Subject requires a craniectomy (the bone flap is not replaced during the current surgery).\n* 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.)\n* Subject requires a craniotomy across the sinus for which Tetranite is applied adjacent to or within the sinus to fixate the cranial flap.\n* Subject has a condition with anticipated survival shorter than six months.\n* 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.\n* 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.\n* Subject receives warfarin, heparin, other anticoagulant agents on a daily basis and pre-surgical, standard of care drug wash-out did not occur.\n* Subject is pregnant, breast-feeding, or intended to become pregnant during the course of the study.","75 Years",{"count":66,"type":19},15,[22],"This clinical pilot study will evaluate the use of a bioresorbable bone adhesive to improve cranial flap fixation at two study time points (at the time of fixation and 6 months). The aim of this Pilot Study is to demonstrate the safety and efficacy of the use of Tetranite for Cranial Flap Fixation (TN-CFF) to allow clinical study of the TN-CFF device in a greater number of patients.",[51],[71,72,73],"cranial flap fixation","bone adhesive","bioresorbable","RECRUITING","2025-03-06",{"date":77,"type":30},"2025-03-11",{"date":79,"type":30},"2025-01-15",{"date":81,"type":19},"2027-01-15",{"name":36,"class":37},1,""]