NCT02299323

INDEPENDENCE Spacer for Lumbar Fusion

Circumferential Lumbar Spinal Fusion for Treatment of Degenerative Disc Disease: A Prospective, Non-Randomized Clinical Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Globus Medical Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction following circumferential fusion using the INDEPENDENCE® integrated plate and spacer with REVOLVE® Stabilization System for the treatment of severe low back pain due to lumbar disc degeneration unresponsive to 6 months of non-operative treatment.

Detailed description

A total of thirty subjects will be enrolled at Scott \& White Healthcare. The INDEPENDENCE spacer will be filled with autogenous bone graft material. The devices subject to this Agreement have received 510(k) clearance from the FDA for the indications specified in this Agreement. Patients will be followed for 2 years with evaluations at the following time intervals: preoperatively (within 2 months of surgery) and postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	INDEPENDENCE	Lumbar Integrated plate and spacer, with percutaneous screws and rods.

Timeline

• Start date: 2012-01-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-11-24
• Last updated: 2016-08-10

Locations

1 site across 1 country: United States