Interbody Systems: Post Market Clinical Follow-up Study

Status Recruiting

Clinical Trial Summary

This is a prospective, multi-center study of subjects who will undergo spinal fusion surgery utilizing Stryker Interbody Systems that require post market clinical follow up (PMCF). The primary study hypothesis for each system is that the mean change in NDI (cervical) or ODI (lumbar) from baseline to Month 12 < -10, that is, the mean improvement exceeds 10 points. In supporting analysis, the same hypotheses will be tested for mean change from baseline to 24 months to demonstrate durability of effectiveness.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04911257
Study type	Observational
Source	K2M, Inc.
Contact	Ajay Rastogi, BS
Phone	201-749-2347
Email	ajay.rastogi@stryker.com
Status	Recruiting
Phase
Start date	December 7, 2021
Completion date	February 1, 2027

View Details

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