Spinal StenosisNCT03041896

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

An observational study of Spinal Stenosis, run by Paradigm Spine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Spinal Stenosis
What is being tested?: coflex® Interlaminar Technology
Type of treatment: Medical device
How many people: 5,050 participants
Where: No sites listed yet
Study dates: Jul 2016to Aug 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

There are no exclusion criteria's for this study.

About this study

Official title: Retrospective Evaluation of the Clinical and Radiographic 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.

Read the 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.

Conditions: Spinal Stenosis
Being tested: coflex® Interlaminar Technology
Medical subject headings: Spinal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

coflex® Interlaminar TechnologyDevice
Interlaminer Technology

Study groups in NCT03041896
Study group	Role	What they receive
Decompression		Standard of care decompression for spinal stenosis, 1 or 2 levels. Receives: Device: coflex® Interlaminar Technology
Fusion		Standard pedical and rod fixation with standard decompression, 1 or 2 levels. Receives: Device: coflex® Interlaminar Technology
coflex®		Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels. Receives: Device: coflex® Interlaminar Technology
Hybrid		coflex and fusion at adjacent levels Receives: Device: coflex® Interlaminar Technology

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Duration of Follow-up Care to Evaluate Overall Effectiveness of the Use of the Coflex® Interlaminer Technology
To assess the overall duration of follow-up care to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology verses decompression.
Measured: Study Duration Up to 6 months for data collection
Overall Incidence of Secondary Surgical Interventions Post Surgeries.
To analyze the incidence of secondary surgical interventions to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology vs. decompression.
Measured: Study Duration up to 6 months data

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.
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.
Measured: Study Duration Up to 6 months for data collection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2016Aug 2018

First posted3 Feb 2017 (estimated)
Study startJul 2016
Primary completionDec 2017
Study completionAug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Spinal StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 5,050 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03041896
Sponsor's protocol ID: CRDC2016
Status last verified: May 2020
First submitted: 6 Oct 2016
Last updated: 19 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: There are no benefits to the subject as this data is being collected to obtain additional clinical evidence to support publications and marketing.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingObservational study
Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis
Degenerative Lumbar Spinal Stenosis, Lumbar Foraminal Stenosis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis

All Spinal Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Retrospective Evaluation of the Clinical and Radiographic Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion.
ClinicalTrials.gov ID: NCT03041896
Acronym / sponsor ID: CRDC2016
Conditions: Spinal Stenosis
Study type: Observational
Recruitment status: Completed
Enrolment: 5,050 participants (actual)
Lead sponsor: Paradigm SpineIndustry (pharma, biotech, devices)
Collaborators: MCRA
Study start: Jul 2016 (actual)
Primary completion: Dec 2017 (actual)
Study completion: Aug 2018 (actual)
First posted: 3 Feb 2017 (estimated)
Results: Posted 19 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 4

Arm	Type	Receives
Decompression	–	Device: coflex® Interlaminar TechnologyStandard of care decompression for spinal stenosis, 1 or 2 levels.
Fusion	–	Device: coflex® Interlaminar TechnologyStandard pedical and rod fixation with standard decompression, 1 or 2 levels.
coflex®	–	Device: coflex® Interlaminar TechnologyDecompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.
Hybrid	–	Device: coflex® Interlaminar Technologycoflex and fusion at adjacent levels

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

There are no exclusion criteria's for this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
coflex® Interlaminar TechnologyInterlaminer Technology	Device	Decompression, Fusion, Hybrid, coflex®

Primary outcome

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.
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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 19 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Decompression	1,486	1,486
Fusion	1,009	1,009
Coflex®	2,299	2,236
Hybrid	256	253

Primary outcome: 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. Mean (Standard Deviation). Unit: days

Measure	Coflex® n = 2058	Decompression n = 1428
Value	201.26 (208.64)	191.75 (247.23)

Population analysed: The following arms: coflex® and Decompression, were the only arms where this data was collected and compared for this study.

Primary outcome: Overall Incidence of Secondary Surgical Interventions Post Surgeries.

Time frame: Study Duration up to 6 months data. Count of participants. Unit: Participants

Measure	Decompression n = 1428	Coflex® n = 2058	Fusion n = 1009
Value	126	125	99

Population analysed: The following arms: coflex® , Fusion, and Decompression, were the only arms where this data was collected and compared for this study.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Not applicable as safety data were not collected during the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Decompression	0 of 0	0 of 0
Fusion	0 of 0	0 of 0
Coflex®	0 of 0	0 of 0
Hybrid	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. There are no benefits to the subject as this data is being collected to obtain additional clinical evidence to support publications and marketing.

Related trials for Spinal Stenosis

Not yet recruitingObservational study
Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis
Degenerative Lumbar Spinal Stenosis, Lumbar Foraminal Stenosis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Abigail Allen study director

MCRA

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Stenosis, run by Paradigm Spine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03041896.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.