Retrospective Evaluation of Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion
NCT ID: NCT03041896
Last Updated: 2020-05-19
Study Results
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View full resultsBasic Information
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COMPLETED
5050 participants
OBSERVATIONAL
2016-07-31
2018-08-31
Brief Summary
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Detailed Description
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The height of the neuroforamen is maintained and the facet joints will be relieved. By this a further destruction is prevented. Unlike conventional stabilization methods as for example spinal fusion, the function of the segment will be maintained and adjacent structures will be effectively protected.
Possible risks, which could occur after implantation of the coflex® Interlaminar Technology are breakage of the implant, displacement of the implant, pain which is caused by the implant, infections, bleedings and hematoma. The benefit of the study lies in the fact that first-time retrospective data is raised for potential improvement regarding therapy of lumbar back pain with the treatment of the lumbar spinal stenosis, which, in the future, can lead to an improvement of the therapy.
In this study, Paradigm Spine will retrospectively collect clinical and radiographic data for patients treated with the coflex® Interlaminar Technology during normal conditions of use. This data will provide evidence to support publications and marketing.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Decompression
Standard of care decompression for spinal stenosis, 1 or 2 levels.
coflex® Interlaminar Technology
Interlaminer Technology
Fusion
Standard pedical and rod fixation with standard decompression, 1 or 2 levels.
coflex® Interlaminar Technology
Interlaminer Technology
coflex®
Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.
coflex® Interlaminar Technology
Interlaminer Technology
Hybrid
coflex and fusion at adjacent levels
coflex® Interlaminar Technology
Interlaminer Technology
Interventions
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coflex® Interlaminar Technology
Interlaminer Technology
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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MCRA
INDUSTRY
Paradigm Spine
INDUSTRY
Responsible Party
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Principal Investigators
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Abigail Allen
Role: STUDY_DIRECTOR
MCRA
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CRDC2016
Identifier Type: -
Identifier Source: org_study_id
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