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Completed

NCT Number: NCT03041896

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

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.

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Key information

Conditions

Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

coflex® Interlaminar Technology

Device

Interlaminer Technology

Primary outcomes

  1. Overall Duration of Follow-up Care to Evaluate Overall Effectiveness of the Use of the Coflex® Interlaminer Technology

    Time frame: Study Duration Up to 6 months for data collection

    To assess the overall duration of follow-up care to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology verses decompression.

  2. Overall Incidence of Secondary Surgical Interventions Post Surgeries.

    Time frame: Study Duration up to 6 months data

    To analyze the incidence of secondary surgical interventions to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology vs. decompression.

Secondary outcomes

  1. The Secondary Objectives Include Measuring and Comparing Clinical, Radiologic, and Patient Reported Outcomes at Baseline, Interim and/or Final Follow-up Visits.

    Time frame: Study Duration Up to 6 months for data collection

    To assess the impact of demographics and risk factors on clinical, radiologic, and patient reported outcomes, and to assess the operative details and safety outcomes associated with the use of the device.

    The clinical outcomes will be summarized; however, since the collection of these measures is not standard of care, this data will only be collected as available. In addition, data will be used to analyze the association between coflex® Interlaminar Technology use and outcomes with age, race, workers' compensation, smoking status, and gender.

Sponsors and collaborators

Lead sponsor

Paradigm Spine

Industry

Collaborators

  • MCRA

Registry information

Official study title

Retrospective Evaluation of the Clinical and Radiographic Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion.

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 3, 2017
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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