Coflex Interlaminar Technology

Condition: Spinal Stenosis

Eligibility

Key Inclusion Criteria

  • At least 40 years old
  • Radiographic confirmation of at least moderate lumbar stenosis
  • Radiographic confirmation of no angular or translatory instability of the spine at index or adjacent levels

Key Exclusion Criteria

  • More than two contiguous vertebral levels requiring surgical decompression
  • Prior surgical procedure that resulted in translatory instability of the lumbar spine
  • More than one surgical procedure at any combination of lumbar levels

Full Study Name

A Two- and Five-Year Comparative Evaluation of Clinical Outcomes in the Treatment of Degenerative Spinal Stenosis With Concomitant Low Back Pain by Decompression With and Without Additional Stabilization Using the Coflex Interlaminar Technology for FDA Real Conditions of Use Study (IRB no. 43458)

Summary

This study focuses on patients diagnosed with degenerative lumbar spinal stenosis whose symptoms have not responded to non-surgical treatment. The purpose of the study is to evaluate the safety and effectiveness of the Coflex Interlaminar System by comparing short- and long-term results from patients who undergo standard decompression surgery versus those who undergo decompression surgery plus the addition of the Coflex System.

The Coflex procedure involves decompression surgery to remove the problem bone and tissue pressing on the spinal nerves, then implanting the study device through the lower back in the space between the affected vertebrae. The Coflex is designed to stabilize the vertebra while potentially still allowing some motion in the spine. The use of the the Coflex Interlaminar System in this study is investigational.

Phase
Phase IV


Principal Investigator

Alexandre Rasouli, MD

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