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Interbody Systems: Post Market Clinical Follow-up Study

NCT04911257 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2025-04-18

No results posted yet for this study

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.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

Cervical or Lumbar Spinal fusion

This is a prospective, multi-center study of subjects who will undergo spinal fusion surgery utilizing certain Stryker Interbody Systems.

Sponsors & Collaborators

  • K2M, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-07
Primary Completion
2025-02-12
Completion
2025-03-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04911257 on ClinicalTrials.gov