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

Paradigm Spine

Status: Completed

Conditions: Spinal Stenosis

Treatments: Device: Implantation of coflex Interlaminar Technology; Procedure: Decompression; Device: Posterolateral Fusion and Implantation of Pedicle Screws

Study type: Interventional

Funder types: Industry

Identifiers

NCT00534235

PS-001

Details and patient eligibility

About

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

Full 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).

Enrollment: 322 patients

Sex

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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322 participants in 2 patient groups

Posterolateral Fusion w/Pedicle Screws

Active Comparator group

Description:

Control: Posterolateral fusion and implantation of pedicle screws after decompression

Treatment:

Procedure: Decompression

Device: Posterolateral Fusion and Implantation of Pedicle Screws

coflex Interlaminar Technolgy

Active Comparator group

Description:

Investigative: Implantation of coflex Interlaminar Technology after decompression

Treatment:

Procedure: Decompression

Device: Implantation of coflex Interlaminar Technology