NCT00534235

Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis

Post-Approval Study to Investigate The Long Term (5-Year) Survivorship of Coflex Compared to Control Fusion Study Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 322 (actual)
• Sponsor: Paradigm Spine · Industry
• Sex: —
• Age: —
• Healthy volunteers: Not accepted

Summary

Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis

Detailed description

The primary objective of this post-approval study is to examine the long-term survivorship of the coflex®. The coflex® Interlaminar Technology is an interlaminar stabilization device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The coflex® is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected level(s).

Conditions

• Spinal Stenosis

Interventions

Type	Name	Description
PROCEDURE	Decompression	Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain
DEVICE	Posterolateral Fusion and Implantation of Pedicle Screws
DEVICE	Implantation of coflex Interlaminar Technology

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2007-09-24
• Last updated: 2020-02-06
• Results posted: 2019-02-27