Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05740176

The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery

Cervical Degenerative Disc Disease Clinical Trial

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 Two-Level Symptomatic Cervical Degenerative Disc Disease (DDD)

Clinical Trial Summary

A multicenter, prospective, non-randomized, historically controlled study. To 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 two levels from C3 to C7 are and are unresponsive to conservative management. Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, and 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 200 patients will be enrolled to the investigational group .The objective of this clinical study is to evaluate the safety and effectiveness of the two-level Synergy Disc compared to conventional two-level ACDF in skeletally mature patients for reconstruction of two contiguous discs from C3 to C7 following discectomy at two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with neck pain or myelopathy due to abnormalities localized to the levels of the two contiguous disc spaces that are unresponsive to conservative management. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05740176
Study type Interventional
Source Synergy Spine Solutions
Contact Jane M Jacob, PhD
Phone 512-289-5370
Email janejacob@synergyspinesolutions.com
Status Recruiting
Phase N/A
Start date June 1, 2023
Completion date December 1, 2025
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06383962 - Post-Market Data Collection to Evaluate the Performance of the Synergy Disc®
Not yet recruiting NCT06413225 - Post-Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc®
Active, not recruiting NCT04469231 - The Synergy Disc To Anterior Cervical Discectomy and Fusion N/A
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 NCT01097486 - Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy Phase 2
Completed NCT01106417 - Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion Phase 1/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
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