Interbody Systems: Post Market Clinical Follow-up Study
Public ClinicalTrials.gov record NCT04911257. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multi Center, Prospective Evaluation for Clinical and Radiographic Outcomes Utilizing Stryker Spine Cervical and Lumbar Interbody Systems: Observational Post Market Clinical Follow up Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04911257
- Recruitment status
- Terminated
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 28 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 6, 2021
- Primary completion
- Feb 11, 2025
- Completion
- Mar 20, 2025
- Last update posted
- Apr 17, 2025
2021 – 2025
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Spine Institute of Louisiana Foundation, Inc. | Shreveport | Louisiana | 71101 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| The Spine Clinic of Oklahoma City | Oklahoma City | Oklahoma | 73114 | — |
| Inova Neurosciences Research | Falls Church | Virginia | 22042 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04911257, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 17, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04911257 live on ClinicalTrials.gov.