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Advent™ Cervical Disc Versus ACDF for Treatment of One Level Degenerative Disc Disease (IDE Study)

Cervical Degenerative Disc Disease Clinical Trial

Official title:
Clinical Trial Comparing the Blackstone Advent™ Cervical Disc to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of One Level Degenerative Disc Disease

Clinical Trial Summary

The purpose of this study is to establish the safety and effectiveness of the Advent™ Cervical Disc compared to Anterior Cervical Discectomy and Fusion (ACDF) in treating degenerative disc disease at a single-level in the cervical spine (from C3 to C7) following cervical discectomy in skeletally mature patients (at least 18 years of age).

Clinical Trial Description

Following surgery study subjects will be evaluated at the following intervals: 6 wks (± 2wks); 3 Months (±2 wks); 6 Month (±1 months); 12 and 24 Month (±2 months) and annually until the last subject enrolled completes their 24 Month follow-up ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00637312
Study type Interventional
Source Orthofix Inc.
Contact
Status Terminated
Phase N/A
Start date March 2008
Completion date February 2013
View Details
See also
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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
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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