N/A
Completed N=5,050
Retrospective Evaluation of Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion
Source: ClinicalTrials.gov NCT03041896 ↗Enrolled (actual)
5,050
Serious AEs
—
Results posted
May 2020
Primary outcomePrimary: Overall Duration of Follow-up Care to Evaluate Overall Effectiveness of the Use of the Coflex® Interlaminer Technology — 201.26; 191.75 days
Summary
To evaluate clinical, radiologic and patient-reported outcomes who have been treated 1 or 2 levels with the coflex® Interlaminar Technology or decompression with or without fusion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Duration of Follow-up Care to Evaluate Overall Effectiveness of the Use of the Coflex® Interlaminer Technology |
201.26; 191.75 | — |
| PRIMARY Overall Incidence of Secondary Surgical Interventions Post Surgeries. |
126; 125; 99 | — |
| SECONDARY The Secondary Objectives Include Measuring and Comparing Clinical, Radiologic, and Patient Reported Outcomes at Baseline, Interim and/or Final Follow-up Visits. |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients must meet the criteria specified in the device labeling including radiographic confirmation of at least moderate lumbar stenosis, which narrows the central spinal canal at one or two contiguous levels from L1-L5 that require surgical decompression.
Exclusion Criteria
- There are no exclusion criteria's for this study.
Data sourced from ClinicalTrials.gov (NCT03041896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.