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

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ClinicalTrials.gov Identifier: NCT03041896
Recruitment Status : Completed
First Posted : February 3, 2017
Results First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
Musculoskeletal Clinical Regulatory Advisers
Information provided by (Responsible Party):
Paradigm Spine

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Spinal Stenosis Device: coflex® Interlaminar Technology

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.

Study Design
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Study Type : Observational
Actual Enrollment : 5050 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Evaluation of the Clinical and Radiographic Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion.
Actual Study Start Date : July 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Groups and Cohorts
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Group/Cohort Intervention/treatment
Decompression
Standard of care decompression for spinal stenosis, 1 or 2 levels.
 Device: coflex® Interlaminar Technology
Interlaminer Technology
Fusion
Standard pedical and rod fixation with standard decompression, 1 or 2 levels.
 Device: coflex® Interlaminar Technology
Interlaminer Technology
coflex®
Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.
 Device: coflex® Interlaminar Technology
Interlaminer Technology
Hybrid
coflex and fusion at adjacent levels
 Device: coflex® Interlaminar Technology
Interlaminer Technology


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041896


Sponsors and Collaborators
Paradigm Spine
Musculoskeletal Clinical Regulatory Advisers
Investigators
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Study Director: Abigail Allen Musculoskeletal Clinical Regulatory Advisers
  Study Documents (Full-Text)

Documents provided by Paradigm Spine:
Study Protocol and Statistical Analysis Plan  [PDF] November 2, 2016

More Information
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Responsible Party: Paradigm Spine
ClinicalTrials.gov Identifier: NCT03041896    
Other Study ID Numbers: CRDC2016
First Posted: February 3, 2017    Key Record Dates
Results First Posted: May 19, 2020
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There are no benefits to the subject as this data is being collected to obtain additional clinical evidence to support publications and marketing.
Additional relevant MeSH terms:
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Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases