NCT00635843

MAVERICK™ Total Disc Replacement- Pivotal Study

"A Prospective, Randomized Controlled Clinical Investigation of MAVERICK™ Total Disc Replacement in Patients With Degenerative Disc Disease"

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 577 (actual)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to assess the safety and effectiveness of the MAVERICK™ Total Disc Replacement as a method of treating patients with lumbar degenerative disc disease at one level from L4-S1, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will be examined.

Detailed description

For this clinical trial, there are two treatment groups, i.e., investigational patients who receive the MAVERICK™ Total Disc Replacement and control patients who receive the anterior lumbar interbody fusion procedure with INFUSE® Bone Graft/LT-CAGE® Lumbar Tapered Fusion Device. Each investigational site will enroll patients in a 2:1 investigational:control treatment randomization scheme.

Conditions

• Spinal Diseases

Interventions

Type	Name	Description
DEVICE	MAVERICK™ Disc	The MAVERICK™ disc is a spinal arthroplasty system and is intended to replace a damaged disc in the lumbar spine. It is a permanent implant used to maintain motion at the treated level and is inserted using an anterior surgical approach.
DEVICE	LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft	The control is the treatment with LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft. It is commercially available for anterior lumbar spine interbody fusion procedures.

Timeline

• Start date: 2003-04-01
• Primary completion: 2006-10-01
• Completion: 2010-11-01
• First posted: 2008-03-14
• Last updated: 2013-08-02

Locations

32 sites across 1 country: United States