A Pivotal Clinical Trial Evaluating the Safety and Effectiveness of Adherus™ AutoSpray and Adherus™ AutoSpray ET Dural Sealant When Used as a Dural Sealant in Spinal Procedures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Duraplasty
- Sponsor
- Stryker Craniomaxillofacial
- Enrollment
- 114
- Locations
- 14
- Primary Endpoint
- The proportion of treated subjects who are free from the following incidences:
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to test an experimental device, the Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant, in spinal surgical procedures.
This study is being done to compare Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant to DuraSeal Exact Spinal Sealant, which has already received Federal Food and Drug Administration (FDA) approval in spinal procedures.
Detailed Description
This is a prospective, randomized, controlled, single-blind, multicenter, pivotal trial that will evaluate the safety and effectiveness of Adherus Dural Sealant when used in conjunction with standard methods of dural repair in spinal procedures. This trial uses the commercially available DuraSeal Exact as an active control. The trial is designed to demonstrate non-inferiority of Adherus Dural Sealant to DuraSeal Exact. Subjects who are undergoing spinal surgery, consent to participate in this trial and experience a durotomy will be considered for study enrollment. Following a two-tiered inclusion/exclusion consideration, subjects will be randomized intraoperatively using a 1:1 randomization ratio. Up to 90 subjects will be randomized to treatment with either Adherus Dural Sealant or DuraSeal Exact with at least 50% of subjects undergoing procedures at lumbar or lumbosacral levels. Up to 30 investigational sites within the United States will participate in this trial. A primary composite endpoint evaluating safety and effectiveness will be measured within a 90-day required follow-up period post-procedure. Subjects will be followed at discharge or between postoperative days (POD) 1-4 from the index procedure (whichever occurs first) and at 30 days and 90 days post-index procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is ≥ 18 and ≤ 75 years old.
- •Subject is scheduled for an elective spinal procedure that will require a planned durotomy.
- •Subject requires a procedure involving a Class I/clean wound (uninfected surgical wound in which no inflammation is encountered).
- •Subject is able and willing to provide informed consent and HIPAA authorization.
- •Subject is able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.
- •Intra-Operative Inclusion Criteria:
- •Subject has durotomy edges that can be re-approximated using the investigator's standard methods of dural repair.
Exclusion Criteria
- •Subject has clinically significant hydrocephalus or clinical evidence of altered CSF dynamics.
- •Subject has a pre-existing external lumbar CSF drain or internal CSF shunt.
- •Subject has experienced previous CSF leak (secondary to trauma, neoplasm, surgery, or other etiology).
- •Subject is undergoing a Chiari malformation procedure.
- •Subject has undergone a previous spinal procedure in the same anatomical location.
- •Subject has had radiation treatment to the surgical site, or standard fractionated radiation therapy is planned within ten days post indexprocedure.
- •Subject has spinal metallic implants that may cause significant imaging artifact on the MRI evaluation of the spine.
- •Subject has metallic implant(s) that are not MRI compatible, e.g., cochlear implant, neurostimulator, stent, surgical clip, cardiac pacemakers, or other non-MRI compatible implants, or an elective implant of such devices is planned during the course of the study. Note: mercury amalgam dental fillings or similar metallic dental prostheses are not an exclusion criterion.
- •Subject has a known malignancy or another condition with anticipated survival shorter than six months.
- •Subject has undergone chemotherapy treatment, excluding hormonal therapy, within three weeks prior to the planned index procedure, or chemotherapy treatment is planned within two weeks after the index procedure is performed.
Outcomes
Primary Outcomes
The proportion of treated subjects who are free from the following incidences:
Time Frame: 90 Days
* CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 90-day follow-up period following the index procedure * Unplanned retreatment of the original surgical site adjudicated by the Clinical Events Committee (CEC) to be device-related, other than CSF leak or pseudomeningocele formation or those related to the subject's pre-existing condition, during the 90-day follow-up period including: * treatment for deep infection * treatment for meningitis * minimally invasive procedures or return to the operating room for neurosurgical complications
Secondary Outcomes
- Secondary endpoints, which will only be tested for superiority of Adherus over DuraSeal Exact after the primary objective of the study has been met:(30 Day, 90 Day)