A PROSPECTIVE, RANDOMIZED, TWO-ARM, CONTROLLED, SINGLE-BLIND, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ARTIFIX® DURAL REPAIR SEALANT GRAFT IN CRANIAL AND SPINE SURGERY (NEOFIX STUDY)

Inclusion criteria

Pre-operative inclusion criteria:

• Male or female aged ≥18 and <80 years.
• Subject is scheduled for an elective cranial or spine surgery with a potential[EG4.1] dural defect that can be repaired by ArtiFix® graft or Control. The maximal estimated dural defect is 25cm2 with an intact dural margins of at least 5 mm surrounding the defect.
• Subject has undergone MRI or CT that includes the planned implantation area in the past 6 months before screening.
• Surgical wound is expected to be Class I/clean.
• Subject understands the study requirements and procedures and provides written Informed Consent before any study-specific tests or procedures. Subject is able and willing to adhere to the follow-up visits and tests.

Intra-operative Inclusion criteria:

• CSF leakage is observed from the dural defect, either spontaneously or during a Valsalva maneuver.
• The ArtiFix® or control can cover a maximum dural defect size of 25 cm². The dural defect must be suitable for coverage with at least 5 mm of intact dural surface surrounding the defect.

Exclusion criteria

Pre-operative exclusion criteria:

• Dural gap is ≤ 2 mm in cranial procedures. In spine procedures the minimal dural gap is not limited.
• Subject is unable to undergo MRI after the surgery (only closed bore MRI is allowed; open bore is not allowed).
• Subject is an acute cranial or spine traumatic surgical case or diagnosed as nontraumatic hemorrhagic CVA that requires urgent craniectomy.
• Subject is operated to repair Chiari malformation, or with a transsphenoidal approach, or that their surgery involves penetration of air cells, of any kind.
• Subject had a previous surgery in the same anatomical site.
• Subject has known hydrocephalus or other CSF obstruction disorder or has been treated for hydrocephalus with shunt insertion in the past 10 years.
• Subject is currently or was diagnosed in the past 5 years with malignancy, excluding basal cell carcinoma or low-grade tumors (i.e., meningioma, ependymoma, schwannoma, hemangioblastoma and other tumors defined as low grade, are eligible to participate).
• Intra-operative Valsalva maneuver poses a risk to the subject, as determined by the surgeon or the anesthesiologist.
• Subject has a local or systemic infection (e.g. urinary tract infection, active pneumonia) or evidence of any surgical site infection, fever > 38.3℃, or positive blood culture.
• Subject has a compromised immune system or an active autoimmune disease, or is on immunosuppressant agents, long term anti-inflammatory biological agents or is on chronic systemic steroid treatment (excluding peri-operative steroid treatment).
• Subjected is diagnosed with sepsis, or systemic collagen disease.
• Subject at high risk of delayed or failed wound healing due to past treatments or conditions.
• Subject has been diagnosed with kidney failure regardless of grade, as evident by serum creatinine levels >1.3 mg/dL.
• Subject was diagnosed with liver disease evident by any of the following test results: ALT > 55 U/L, AST > 48 U/L, ALP > 129 U/L, GGT > 61 U/L, Total bilirubin > 1.3 mg/dL, Albumin < 3.5 g/Dl, INR > 1.2, or PT > 15 sec.
• Subject has been diagnosed with an uncontrolled diabetes mellitus, as evident by HbA1c > 7%, or suffered recurrent episodes of hypoglycemia in the past 2 months.
• Subject had chemotherapy and/or radiotherapy in the past 8 weeks before surgery or is planned to have chemotherapy or radiotherapy less than 8 weeks after surgery.
• Subject requires an external ventricular or lumbar CSF drain that must be left in place after surgery.
• Subject has congenital or acquired coagulopathy.
• The subject was classified as exhibiting drug abuse.
• Subject has any condition that, in the Principal Investigator's judgment, may compromise the subject's safety or preclude compliance with the study investigation plan and/or device instructions.
• Subject is participating in another clinical trial that tests any other drug or device.
• Subject is pregnant or breast-feeding at screening or intends to become pregnant during the study period.
• Subject has known history of sensitivity or allergy to any component of the ArtiFix®.

Intra-operative Exclusion criteria:

• Dural gap is ≤ 2 mm in cranial procedures. In spine procedures the minimal dural gap is not limited.