Trials / Terminated
TerminatedNCT04911257
Interbody Systems: Post Market Clinical Follow-up Study
Multi Center, Prospective Evaluation for Clinical and Radiographic Outcomes Utilizing Stryker Spine Cervical and Lumbar Interbody Systems: Observational Post Market Clinical Follow up Study
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 28 (actual)
- Sponsor
- K2M, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-12-07
- Primary completion
- 2025-02-12
- Completion
- 2025-03-21
- First posted
- 2021-06-03
- Last updated
- 2025-04-18
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04911257. Inclusion in this directory is not an endorsement.