Retrospective Evaluation of Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion

NCT ID: NCT03041896

Last Updated: 2020-05-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5050 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Spinal Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Decompression

Standard of care decompression for spinal stenosis, 1 or 2 levels.

coflex® Interlaminar Technology

Intervention Type DEVICE

Interlaminer Technology

Fusion

Standard pedical and rod fixation with standard decompression, 1 or 2 levels.

coflex® Interlaminar Technology

Intervention Type DEVICE

Interlaminer Technology

coflex®

Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.

coflex® Interlaminar Technology

Intervention Type DEVICE

Interlaminer Technology

Hybrid

coflex and fusion at adjacent levels

coflex® Interlaminar Technology

Intervention Type DEVICE

Interlaminer Technology

Interventions

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coflex® Interlaminar Technology

Interlaminer Technology

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MCRA

INDUSTRY

Sponsor Role collaborator

Paradigm Spine

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

View Document

Other Identifiers

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CRDC2016

Identifier Type: -

Identifier Source: org_study_id

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