NCT00637312

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Orthofix Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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

Conditions

• Cervical Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	Cervical Artificial Disc (Advent™ Cervical Disc)	Advent™ Cervical Disc
DEVICE	Hallmark™ Anterior Cervical Plate System	Hallmark™ Anterior Cervical Plate System with AlloQuent Structural Allograft (corticocancellous allograft bone)

Timeline

• Start date: 2008-03-01
• Primary completion: 2011-07-01
• Completion: 2013-02-01
• First posted: 2008-03-17
• Last updated: 2014-03-27
• Results posted: 2014-03-27

Locations

13 sites across 1 country: United States