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Interbody System

Degenerate Disc Disease for Degenerative Disc Disease

N/A
Recruiting
Research Sponsored by K2M, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 and 6 weeks, 3, 6, 12 and 24 months
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 and 6 weeks, 3, 6, 12 and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 and 6 weeks, 3, 6, 12 and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Adjacent Segment Degeneration
Angular Motion
Bridging Bone
+12 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Degenerate Disc DiseaseExperimental Treatment1 Intervention
Subjects who will undergo spinal fusion surgery utilizing Stryker Interbody Systems.

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Who is running the clinical trial?

K2M, Inc.Lead Sponsor
8 Previous Clinical Trials
2,896 Total Patients Enrolled
~199 spots leftby Dec 2026
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