Clinical trial NCT03041896: Retrospective Evaluation of Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion
Official title: Retrospective Evaluation of the Clinical and Radiographic Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Stenosis
Lead sponsor: Paradigm Spine
Sponsor class: INDUSTRY
Collaborators: name: MCRA
First posted: 2017-02-03
Enrollment: 5050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed description: The coflex® Interlaminar Technology - manufactured by Paradigm Spine - is intended for use as a permanent implant between the lamina of 1 or 2 lumbar motion segments in the treatment of moderate to severe lumbar spinal stenosis. The device is specifically designed to provide stabilization without fusion in cases of stenosis with or without facet joint hypertrophy, subarticular recess stenosis or foraminal stenosis. It is restricted for use to one or two levels in the region of L1 - L5.

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.

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.

Primary outcomes:
measure: Overall Duration of Follow-up Care to Evaluate Overall Effectiveness of the Use of the Coflex® Interlaminer Technology
timeFrame: Study Duration Up to 6 months for data collection
measure: Overall Incidence of Secondary Surgical Interventions Post Surgeries.
timeFrame: Study Duration up to 6 months data
Secondary outcomes:
measure: The Secondary Objectives Include Measuring and Comparing Clinical, Radiologic, and Patient Reported Outcomes at Baseline, Interim and/or Final Follow-up Visits.
timeFrame: Study Duration Up to 6 months for data collection
Other outcomes:
Locations:
Study officials:
affiliation: MCRA
name: Abigail Allen
role: STUDY_DIRECTOR
References: