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Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD

Cervical Degenerative Disc Disease Clinical Trial

Official title:
A Prospective, Multicenter, Controlled Clinical Trial of an Artificial Cervical Disc LP at a Single Level for Symptomatic Cervical Disc Disease

Clinical Trial Summary

The purpose of this clinical trial is to evaluate the safety and effectiveness of the PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical degenerative disc disease at a single level from C3-C4 to C6-C7.

Clinical Trial Description

This pivotal clinical trial was conducted to compare treatment data of the investigational implant device,the PRESTIGE® LP Cervical Disc, with a control patient group receiving a plate. The PRESTIGE® LP Cervical Disc devices were implanted using an anterior surgical approach. Data from control patients receiving anterior cervical discectomy and fusion with an ATLANTIS Anterior Cervical Plate from the initial Artificial Cervical Disc study (NCT00642876) were compared as both treatment groups receive single-level surgical treatment from C3-C4 to C6-C7 for symptomatic cervical degenerative disc disease. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00667459
Study type Interventional
Source Medtronic Spinal and Biologics
Contact
Status Completed
Phase Phase 3
Start date January 2005
Completion date June 2014
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06413225 - Post-Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc®
Not yet recruiting NCT06383962 - Post-Market Data Collection 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Withdrawn NCT01616719 - Evaluation of DTRAX Graft in Patients With Cervical Degenerative Disc Disease N/A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
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
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