Coflex PS3 Actual Conditions for Use Study (PAS003)

January 4, 2024 updated by: Xtant Medical

A 2 and 5 Year Evaluation of Clinical Outcomes in the Treatment of Degenerative Spinal Stenosis With Concomitant Low Back Pain by Decompression With Additional Stabilization Using the Coflex® Interlaminar Technology for FDA Actual Conditions for Use Study.

A 2 and 5 year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with additional stabilization using the coflex® Interlaminar Technology for FDA Actual Conditions of Use Study.

Study Overview

Status

Status

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

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.

Detailed Description

A prospective, multi center, concurrently enrolled, propensity score controlled through Month 60. The purpose is to fully characterize safety and efficacy then the coflex device is used in the intended subject population under actual conditions of use.

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.
Interventional

Enrollment (Estimated)

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.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Recruiting
        • Desert Institute for Spine Care (DISC)
        • Principal Investigator:
          • Nima Salari, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Christopher A. Yeung, MD
        • Sub-Investigator:
          • Justin Field, MD
    • California
      • Irvine, California, United States, 92618
        • Withdrawn
        • Hoag Orthopedics
      • Sacramento, California, United States, 95816
      • San Luis Obispo, California, United States, 93401
        • Recruiting
        • Central Cost Neurological Surgery
        • Principal Investigator:
          • David Yeh, MD
        • Contact:
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Cervical Disc Center of Los Angeles
        • Contact:
        • Principal Investigator:
          • Amir Vokshoor, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Durango, Colorado, United States, 81301
        • Withdrawn
        • Mercy Regional Medical Center
    • Florida
      • Tallahassee, Florida, United States, 32308
        • Terminated
        • Tallahassee Neurological Clinic
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Completed
        • 01L_Northshore University Health System
    • Indiana
      • Lafayette, Indiana, United States, 47905
        • Terminated
        • 24_Unity Surgical Center, LLC
      • Munster, Indiana, United States, 46321
        • Withdrawn
        • Orthopaedic Specialist of Northwest Indiana
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Terminated
        • Spine Institute of Louisiana
    • New Jersey
      • Wayne, New Jersey, United States, 07470
        • Withdrawn
        • St. Joseph's Medical Center
    • New York
      • Great Neck, New York, United States, 11021
        • Recruiting
        • Northwell Health Physician Partners Orthopaedic Institute at Great Neck
        • Principal Investigator:
          • Rohit Verma, MD
        • Contact:
        • Contact:
    • Ohio
      • Toledo, Ohio, United States, 43617
        • Withdrawn
        • Consulting Orthopaedic Associates
    • Oregon
      • Medford, Oregon, United States, 97504
        • Recruiting
        • Southern Oregon Orthpaedics
        • Principal Investigator:
          • Andy Kranenburg, MD
        • Contact:
      • Portland, Oregon, United States, 97225
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Terminated
        • 03L_Thomas Jefferson University
    • Texas
      • Austin, Texas, United States, 78746
        • Recruiting
        • Austin Neurosurgeons
        • Contact:
        • Principal Investigator:
          • Daniel Peterson, MD
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Radiographic confirmation of at least moderate lumbar stenosis at one or two contiguous levels from L1-L5 that require surgical decompression.
  2. Visual Analog Scale back pain score of at least 50 mm on a 100 mm scale.
  3. Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair.
  4. Subject has undergone at least one lumbar injection at any prior time point, AND/OR at least 6 months of prior conservative care without adequate and sustained symptom relief.
  5. Skeletally mature
  6. Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%).
  7. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.
  8. Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

  1. Prior fusion or decompressive laminectomy at 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. Isthmic spondylolisthesis or spondylolysis (pars fracture).
  5. Degenerative lumbar scoliosis (Cobb angle of greater than 25°).
  6. Osteoporsis or is at increased risk of osteoporosis.
  7. Back or leg pain of unknown etiology.
  8. Axial back pain only, with no leg, buttock, or groin pain.
  9. Morbid obesity defined as a body mass index > 40.
  10. Known allergy to titanium, titanium alloys, or MR contrast agents.
  11. Active or chronic infection - systemic or local.
  12. Cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction.

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Other: The coflex® Interlaminar Technology
The coflex device was designed to address the clinical needs of spinal stenosis patients by providing stabilization of the affected level without fusion. The coflex is an interspinous process functional dynamic implant designed to impart a stabilizing effect at the treated level(s). The coflex device was approved by FDA in 2012.
Device: coflex® Interlaminar Technology
Decompression plus coflex® Interlaminar Technology
Other Names:
  • coflex
Active Comparator: Decompression
Lumbar decompression back surgery is when a small portion of the bone over the nerve root and/or disc material from under the nerve root is removed to give the nerve root more space and provide a better healing environment.
Procedure: Decompression
Decompression alone

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
coflex performance compared to IDE
Time Frame: 24and 60 Months
Evaluation of coflex device performance in conjunction with surgical decompression in an actual conditions of use study.
24and 60 Months
coflex performance compared to decompression alone from ESCADA study.
Time Frame: 24 Months
To compare clinical status of patients implanted with the coflex device in conjunction with surgical decompression relative to surgical decompression alone from ESCADA study.
24 Months
Composite Clinical Success (CCS)
Time Frame: 24 Month
  • No secondary surgical interventions
  • No lumbar epidural injection, nerve block procedures at index level to treat spinal stenosis at any lumbar level
  • 15 point improvement in ODI in subjects with no interventions or injections
  • No new or increasing sensor or motor deficit
  • No major device related adverse events
24 Month

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
Change in Oswestry Disability Index (ODI)
Time Frame: Baseline, 24 and 60 months
Quality of life as determined by ODI. In terms of achieving at least a 15 point improvement.
Baseline, 24 and 60 months
Change in Visual Analog Scale (VAS) for low back pain
Time Frame: Baseline, 24 and 60 Months
Low back pain reduction evaluated by use of VAS for back pain. In terms of achieving at least a 20 point improvement.
Baseline, 24 and 60 Months
Change in Visual Analog Scale (VAS) for leg pain
Time Frame: Baseline, 24 and 60 Months
Leg pain reduction evaluated by use of VAS for leg pain. In terms of achieving at least a 20 point improvement.
Baseline, 24 and 60 Months
Neurological Status
Time Frame: Baseline, 6 weeks, 12, 24, 36, 48, 60 Months
Assessment of maintenance of improvement after surgery.
Baseline, 6 weeks, 12, 24, 36, 48, 60 Months
Radiographic Assessments
Time Frame: 6 weeks, 12, 24, 60 Months
  • Significant migration or complete expulsion of implant
  • Spinous process fracture
  • Maintenance of foraminal height
  • adjacent level disease
6 weeks, 12, 24, 60 Months
Modified CCS
Time Frame: 24 Month
CCS will be modified to include no use of a narcotic (opioids or opiates).
24 Month
Medication Usage
Time Frame: 24 Month
No use of narcotic (opioids and/or opiates)
24 Month

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety Evaluation
Time Frame: Procedure, 6 week, 12, 24, 36, 48, 60 Months
Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events, revision, additional stabilizations
Procedure, 6 week, 12, 24, 36, 48, 60 Months

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.
Xtant Medical

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.
MCRA

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 (Actual)

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.
September 9, 2019

Primary Completion (Estimated)

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.
September 1, 2024

Study Completion (Estimated)

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.
November 1, 2027

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).
September 2, 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.
September 18, 2015

First Posted (Estimated)

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.
September 21, 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.
January 5, 2024

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.
January 4, 2024

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.
January 1, 2024

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.
  • PS3/P110008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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