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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04469231
Study type Interventional
Source Synergy Spine Solutions
Contact
Status Active, not recruiting
Phase N/A
Start date October 30, 2020
Completion date January 1, 2026

See also
  Status Clinical Trial Phase
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Not yet recruiting NCT06413225 - Post-Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc®
Completed NCT02417272 - Total Disc Replacement Versus Anterior Cervical Decompression and Fusion N/A
Completed NCT02667067 - Investigation of the Simplify® Cervical Artificial Disc N/A
Withdrawn NCT01616719 - Evaluation of DTRAX Graft in Patients With Cervical Degenerative Disc Disease N/A
Terminated NCT00700739 - Study to Investigate the Performance of Cervical Arthroplasty for the Treatment of Cervical Degenerative Disc Disease Phase 4
Terminated NCT00637312 - Advent™ Cervical Disc Versus ACDF for Treatment of One Level Degenerative Disc Disease (IDE Study) N/A
Terminated NCT03062657 - An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine N/A
Completed NCT01106417 - Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion Phase 1/Phase 2
Completed NCT01097486 - Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy Phase 2
Completed NCT00637156 - Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels N/A
Completed NCT00437190 - Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF N/A
Recruiting NCT05740176 - The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery N/A
Completed NCT00432159 - Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study) N/A
Completed NCT00667459 - Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD Phase 3
Recruiting NCT05880823 - Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc
Recruiting NCT06383949 - Real World Data Collection on the Synergy Disc
Terminated NCT01291134 - PureGen: Radiographic Analysis of Fusion for ACDF
Terminated NCT00640029 - Evaluation of the Prosthetic Disc Replacement N/A
Not yet recruiting NCT05522010 - Dynamic Cervical Implant (DCI) Versus Anterior Cervical Discectomy And Fusion(ACDF) For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD): An RCT N/A