Safety and Effectiveness of TETRANITE Bone Adhesive for Cranial Flap Fixation Compared to Traditional Metal Hardware
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 204
- 主要终点
- Flap immobility at final surgical fixation (patient)
研究概览
简要总结
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.
详细描述
This two arm study will assess the safety and efficacy of TETRANITE, a bioresorbable bone adhesive, for Cranial Flap Fixation as compared to traditional metal hardware. The control arm for this study is the standard of care plating system. Participants will be randomly assigned to either the TETRANITE arm, or the standard of care plating system arm. Participants will generally follow their standard of care follow-up for surgery for one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject, and/or subject's family are able and willing to provide informed consent and HIPAA authorization prior to any study related procedures.
- •Subjects can be any gender, but be between (and including) 18 and 80 years of age
- •Subject is scheduled for a cranial procedure that requires the creation of a bone flap or replacement of a bone flap (i.e., cranioplasty)
- •Subject is scheduled for a cranial procedure in the supratentorial location.
- •Subject is able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.
- •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.
- •Intra-Operative Inclusion Criteria:
- •Width of craniotomy kerf line < 3mm for more than 75% of the bone flap border.
排除标准
- •Subject has undergone a previous, open intracranial neurosurgical procedure in the same anatomical location. (Note: stereotactic biopsy is not exclusionary).
- •Subject requires a craniectomy (the bone flap is not replaced during the current surgery).
- •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.)
- •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).
- •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.
- •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/or 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.
- •Subject has a condition with anticipated survival shorter than one year.
- •Subject receives warfarin, heparin, other anticoagulant agents on a daily basis and pre-surgical, standard of care drug wash-out did not occur.
- •Subject is pregnant, breast-feeding, or intended to become pregnant during the course of the study.
- •Current infection (either superficial or deep) at the planned operative site
- •Sepsis diagnosed within one week before the planned index procedure
研究组 & 干预措施
TETRANITE Bone Adhesive
These participants will receive tetranite to re-adhere the cranial flap following a craniotomy.
干预措施: Tetranite for Cranial Flap Fixation (Combination Product)
Standard of Care Plating System
These participants will receive the standard of care plating system to re-adhere the cranial flap following a craniotomy.
干预措施: Standard of Care Plating System (Device)
结局指标
主要结局
Flap immobility at final surgical fixation (patient)
时间窗: At enrollment surgery
Immobility of the flap prior to surgical closure, assessed by the principal investigator and an independent neurosurgeon.
Flap immobility at 6 months (surgeon)
时间窗: 6 months after index surgery
Flap immobility assessed through a flap mobility assessment by the principal investigator and an independent neurosurgeon.
No incidence of serious adverse events, including unplanned retreatment of the original surgical site, adjudicated by the CEC to be device-related within 6 months of index surgery.
时间窗: 6 months from enrollment
No incidence of serious adverse events, including unplanned retreatment of the original surgical site, adjudicated by the CEC to be device-related within 6 months of index surgery.
次要结局
- Patient reported outcome using PROMIS10(Enrollment through 12 months from index surgery.)
- Flap immobility through 12 months (patient)(12 months)
- Serious adverse events, including unplanned retreatment of the original surgical site, adjudicated by the CEC to be device-related beyond 6 months of index surgery.(6 months from enrollment to 12 months)
- Adverse events, including CSF leaks or wound dehiscence(From enrollment through 12 months after index surgery.)
- Patient reported outcome using VAS Pain Score(Enrollment through 12 months from index surgery)
- Patient reported outcome using Cranio-Facial PROMS(Enrollment through 12 months from index surgery)
- Flap volume change to assess growth/atrophy based on CT at 6 and 12 Months(6 months and 12 months)
- Flap fusion to assess bony bridging of the kerf and burr holes via kerf and burr hole gap volume increase/decrease based on CT at 6 and 12 Months(6 months and 12 months)
- Flap congruence to assess immediate post-operative conformance to surrounding bone(1-4 days from index surgery (+7/-3))
- Flap displacement to assess migration via peak displacement of the flap surface based on CT at 6 and 12 Months compared to post-operative placement(6 months and 12 months)
- Artifact assessment of distortion that obscures lesion detection based on available standard of care MRI throughout the 12- month study period(From enrollment through 12 months following index procedure)