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Coflex PS3 Actual Conditions for Use Study — PAS003  

Spinal Stenosis Lumbar Clinical Trial

Official title:
A 2 and 5 Year Evaluation of Clinical Outcomes in the Treatment of Degenerative Spinal Stenosis With Concomitant Low Back Pain by Decompression With Additional Stabilization Using the Coflex® Interlaminar Technology for FDA Actual Conditions for Use Study.

Clinical Trial Summary

A 2 and 5 year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with additional stabilization using the coflex® Interlaminar Technology for FDA Actual Conditions of Use Study.

Clinical Trial Description

A prospective, multi center, concurrently enrolled, propensity score controlled through Month 60. The purpose is to fully characterize safety and efficacy then the coflex device is used in the intended subject population under actual conditions of use. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02555280
Study type Interventional
Source Xtant Medical
Contact Laura Henderson
Phone 406-813-4107
Email lhenderson@xtantmedical.com
Status Recruiting
Phase N/A
Start date September 9, 2019
Completion date November 2027
View Details
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