The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology

December 20, 2019 updated by: Predicted, Reported and Observed Outcomes Foundation
The purpose of the coflexCOMMUNITY observational study is to collect information on patients with spinal stenosis undergoing back surgery with the coflex® implant, and to look at their outcomes and the cost-effectiveness of this procedure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
325

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Center for Neurology and Spine
      • Scottsdale, Arizona, United States, 85225
        • Arizona Brain and Spine
      • Tucson, Arizona, United States, 85741
        • Northwest NeuroSpecialists
    • California
      • Santa Monica, California, United States, 90403
        • The Spine Institute, Center for Spine Restoration
    • Florida
      • Fort Lauderdale, Florida, United States, 33306
        • Cantor Spine Institute
      • Gainesville, Florida, United States, 32607
        • Southeastern Integrated Medical
      • Gainesville, Florida, United States, 32607
        • The Orthopaedic Institute
      • Melbourne, Florida, United States, 32901
        • The BACK Center
      • Saint Petersburg, Florida, United States, 33703
        • All Florida Orthopaedics
      • Tampa, Florida, United States, 33607
        • Laser Spine Institute
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • OrthoAtlanta
    • Illinois
      • Palos Heights, Illinois, United States, 60463
        • Orthospine Center LTD
      • Springfield, Illinois, United States, 62711
        • Orthopedic Center of Illinois
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's
      • Springfield, Massachusetts, United States, 01107
        • New England Orthopedic Surgeons
    • Missouri
      • Saint Louis, Missouri, United States, 63017
        • The Orthopedic Center of St. Louis
      • Saint Louis, Missouri, United States, 63122
        • Orthopedic Sports Medicine & Spine Care Institute
    • New Jersey
      • Oradell, New Jersey, United States, 07649
        • North Jersey Brain and Spine Center
      • Union, New Jersey, United States, 07083
        • IGEA Brain and Spine
    • New Mexico
      • Roswell, New Mexico, United States, 88201
        • Spine and Orhtopedic Center of New Mexico
    • New York
      • Cooperstown, New York, United States, 13326
        • Bassett Medical Center
    • North Carolina
      • Arden, North Carolina, United States, 28704
        • Blue Ridge Bone and Joint
    • Ohio
      • Dublin, Ohio, United States, 43017
        • OrthoNeuro
      • Sylvania, Ohio, United States, 43560
        • Consulting Orthopaedic Associates
    • Texas
      • Carrollton, Texas, United States, 75010
        • OrthoTexas
      • Dallas, Texas, United States, 75287
        • Center for Spine Care
    • Washington
      • Seattle, Washington, United States, 98372
        • NeoSpine
    • Wyoming
      • Cody, Wyoming, United States, 82414
        • Bighorn Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cohort will be selected from clinic patients scheduled for surgery with coflex device after decompression

Description

Inclusion Criteria:

  1. Patient is skeletally mature and has at least moderate impairment in function, experiences relief in flexion from his/her symptoms of leg/buttocks/groin pain, with or without back pain, and has undergone at least 6 months of non-operative treatment;
  2. Patient is treated surgically at 1 or 2 contiguous lumbar motion segments with the coflex Interlaminar Device from L1-L5 after decompression of stenosis at the affected level(s), where such use is not contraindicated as noted below.

Exclusion Criteria:

  1. Prior fusion or decompressive laminectomy at any index lumbar level;
  2. Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture);
  3. Severe facet hypertrophy that requires extensive bone removal which would cause instability;
  4. Grade II or greater spondylolisthesis;
  5. Isthmic spondylolisthesis or spondylolysis (pars fracture);
  6. Degenerative lumbar scoliosis (Cobb angle of greater than 25°);
  7. Osteoporosis;
  8. Back or leg pain of unknown etiology;
  9. Axial back pain only, with no leg, buttock, or groin pain;
  10. Morbid obesity defined as a body mass index > 40;
  11. Active or chronic infection - systemic or local;
  12. Known allergy to titanium alloys or magnetic resonance imaging (MRI) contrast agents;
  13. Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction;
  14. Vulnerable population including pregnant women, prisoners, students and employees of treating physicians, and others who can be subject to coercion;
  15. Patient is unwilling to complete his/her surveys.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Stenosis patients treated with coflex
Patients with a primary diagnosis of lumbar spinal stenosis treated with coflex after decompression
Device: coflex

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improvement in the Oswestry Disability Index (ODI), compared to pre-surgery
Time Frame: 5 years
The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI). It will be assessed if the improvement in ODI since the pre-surgery status is at least 15 points
5 years
Patient has not undergone any reoperations, removals, revisions, or supplemental fixations;
Time Frame: 5 years
Assessment of reoperations, revisions, removals, or supplemental fixation associated with the coflex device.
5 years
Patient has not had any major device related complications
Time Frame: 5 years
Assessment of major device-related complications, including but not limited to permanent new or increasing sensory or motor deficit at 2 years and 5 years.
5 years
Patient has not undergone any Epidural injections
Time Frame: 5 years
Assessment of lumbar epidural injections
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Zurich Claudication Questionnaire (ZCQ)
Time Frame: 5 years
ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.
5 years
Quality of Life
Time Frame: 5 years
Assessment of the patient's Quality of Life as measured by the Health Outcomes Survey and EQ-5D-5L
5 years
VAS Leg Pain
Time Frame: 5 years
Change in the assessment of leg pain compared to pre-surgery as measured by a Visual Analog Scale (VAS) (on the 100mm scale).
5 years
VAS Back Pain
Time Frame: 5 years
Change in the assessment of back pain compared to pre-surgery as measured by a Visual Analog Scale (VAS) (on the 100mm scale).
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Predicted, Reported and Observed Outcomes Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
SPIRITT Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SR-2015-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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