N/A
N=5,050
Retrospective Evaluation of Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion
Spinal Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT03041896 ↗Enrolled (actual)
5,050
Serious AEs
—
Results posted
May 2020
Primary outcome: Primary: Overall Duration of Follow-up Care to Evaluate Overall Effectiveness of the Use of the Coflex® Interlaminer Technology — 201.26; 191.75 days
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- coflex® Interlaminar Technology (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Paradigm Spine
- Primary completion
- Dec 2017
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. |
— | — |
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.
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.