Ignite Creation Date:
2024-05-06 @ 2:54 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04469231
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2020-07-07
Brief Title:
The Synergy Disc To Anterior Cervical Discectomy and Fusion
Sponsor:
Synergy Spine Solutions
Organization:
Synergy Spine Solutions
Study Overview
Official Title:
A Multi-Center Prospective Historically Controlled Pivotal Trial Comparing The Safety And Effectiveness Of The Synergy Disc To Anterior Cervical Discectomy And Fusion In Patients With One-Level Symptomatic Cervical Degenerative Disc Disease DDD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A multicenter prospective non-randomized historically controlled study Demonstrate the Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion ACDF to treat cervical degenerative disc disease DDD in subjects who are symptomatic at only one level from C3 to C7 that are unresponsive to conservative management Patients will be evaluated preoperatively at the time of surgery and at 6 weeks 3 6 12 and 24 months after surgery Follow-up will continue annually until the last patient reaches 24-month follow-up The primary analysis will occur at 24 months
Detailed Description:
The proposed investigation is a prospective non-randomized multi-center historically controlled comparison of the Synergy Disc to the control of conventional anterior cervical discectomy and fusion ACDF surgery in patients with cervical DDD A total of 175 patients will be enrolled to the investigational group not including approximately 15 training cases The investigational group results will be compared to a historical control data from the ACDF control group which utilized an identical study design A statistically rigorous observational study design using propensity score PS subclassification will be used to demonstrate covariate balance and enhance the quality of inferences regarding effectiveness and safety relative to ACDF control After investigational device enrollment is complete but before most investigational device subjects have reached their 24-month endpoint a data set containing only baseline covariates of prospectively enrolled investigational device patients and historical ACDF control patients will be constructed The propensity score methods detailed below will be implemented by an outcomes-blinded statistician A Propensity Score Memo summarizing the proposed observational design will be developed and submitted for review by stakeholders including FDA The outcomes-blinded statistician will remain blinded until after consensus is achieved that the design is acceptable This will allow for additional outcomes-blinded PS modeling if required The objective of this clinical trial is to demonstrate the Synergy Disc is at least as safe and effective as conventional ACDF to treat cervical DDD in subjects who are symptomatic at only one level from C3 to C7 that are unresponsive to conservative management
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None