NCT00589797

Activ-L™ Artificial Disc Treatment of Degenerative Disc Disease in the Treatment of Degenerative Disc Disease

Clinical Study to Evaluate the Safety and Effectiveness of the Aesculap Activ-L™ Artificial Disc in the Treatment of Degenerative Disc Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 376 (actual)
• Sponsor: Aesculap Implant Systems · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to learn whether an investigational device called the Activ-L Artificial Disc is safe and effective in the treatment of degenerative disc disease of the lower (lumbar) spine.

Detailed description

The objective of this clinical study is to evaluate the safety and effectiveness of the Activ-L Artificial Disc for treatment of single-level degenerative disc disease of the lumbar spine in patients who have been unresponsive to at least six months of prior conservative care. The hypothesis of the study is that the Activ-L Disc is non-inferior to the control (the Charité® Artificial Disc \[DePuy Spine\] or ProDisc-L® Total Disc Replacement \[Synthes Spine\]) with respect to the rate of individual subject success at 24 months. Individual subject success is a composite of effectiveness and safety.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	Activ-L Artificial Disc	Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.
DEVICE	ProDisc-L Total Disc Replacement or Charité Artificial Disc	Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.

Timeline

• Start date: 2007-01-01
• Primary completion: 2012-12-01
• Completion: 2017-01-01
• First posted: 2008-01-10
• Last updated: 2018-12-07
• Results posted: 2018-12-07

Locations

17 sites across 1 country: United States