search
Back to results

Coflex PS3 Actual Conditions for Use Study (PAS003)

Primary Purpose

Spinal Stenosis Lumbar

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
coflex® Interlaminar Technology
Decompression
Sponsored by
Xtant Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Stenosis Lumbar focused on measuring moderate lumbar stenosis, neurogenic claudication, spinal stenosis, low back pain, decompression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Desert Institute for Spinal Care (DISC)Recruiting
  • Hoag OrthopedicsRecruiting
  • Sutter HealthRecruiting
  • Central Cost Neurological SurgeryRecruiting
  • Cervical Disc Center of Los AngelesRecruiting
  • 20_Spine Colorado, PCRecruiting
  • Tallahassee Neurological ClinicRecruiting
  • 01L_Northshore University Health System
  • 24_Unity Surgical Center, LLC
  • 25_Orthopedic Specialist of Northwest IndianaRecruiting
  • 01_Spine Institute of Louisiana
  • 26_St. Joseph's University Medical CenterRecruiting
  • 23_University Orthopaedic Associates at Great NeckRecruiting
  • Consulting Orthopaedic AssociatesRecruiting
  • Southern Oregon OrthpaedicsRecruiting
  • Summit SpineRecruiting
  • 03L_Thomas Jefferson University
  • 22_Austin Brain & SpineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

The coflex® Interlaminar Technology

Decompression

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

coflex performance compared to IDE
Evaluation of coflex device performance in conjunction with surgical decompression in an actual conditions of use study.
coflex performance compared to decompression alone from ESCADA study.
To compare clinical status of patients implanted with the coflex device in conjunction with surgical decompression relative to surgical decompression alone from ESCADA study.
Composite Clinical Success (CCS)
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

Secondary Outcome Measures

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

Full Information

First Posted
September 2, 2015
Last Updated
April 24, 2023
Sponsor
Xtant Medical
Collaborators
MCRA
search

1. Study Identification

Unique Protocol Identification Number
NCT02555280
Brief Title
Coflex PS3 Actual Conditions for Use Study
Acronym
PAS003
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
November 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xtant Medical
Collaborators
MCRA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis Lumbar
Keywords
moderate lumbar stenosis, neurogenic claudication, spinal stenosis, low back pain, decompression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The coflex® Interlaminar Technology
Arm Type
Other
Arm Description
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.
Arm Title
Decompression
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
coflex® Interlaminar Technology
Other Intervention Name(s)
coflex
Intervention Description
Decompression plus coflex® Interlaminar Technology
Intervention Type
Procedure
Intervention Name(s)
Decompression
Intervention Description
Decompression alone
Primary Outcome Measure Information:
Title
coflex performance compared to IDE
Description
Evaluation of coflex device performance in conjunction with surgical decompression in an actual conditions of use study.
Time Frame
24and 60 Months
Title
coflex performance compared to decompression alone from ESCADA study.
Description
To compare clinical status of patients implanted with the coflex device in conjunction with surgical decompression relative to surgical decompression alone from ESCADA study.
Time Frame
24 Months
Title
Composite Clinical Success (CCS)
Description
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
Time Frame
24 Month
Secondary Outcome Measure Information:
Title
Change in Oswestry Disability Index (ODI)
Description
Quality of life as determined by ODI. In terms of achieving at least a 15 point improvement.
Time Frame
Baseline, 24 and 60 months
Title
Change in Visual Analog Scale (VAS) for low back pain
Description
Low back pain reduction evaluated by use of VAS for back pain. In terms of achieving at least a 20 point improvement.
Time Frame
Baseline, 24 and 60 Months
Title
Change in Visual Analog Scale (VAS) for leg pain
Description
Leg pain reduction evaluated by use of VAS for leg pain. In terms of achieving at least a 20 point improvement.
Time Frame
Baseline, 24 and 60 Months
Title
Neurological Status
Description
Assessment of maintenance of improvement after surgery.
Time Frame
Baseline, 6 weeks, 12, 24, 36, 48, 60 Months
Title
Radiographic Assessments
Description
Significant migration or complete expulsion of implant Spinous process fracture Maintenance of foraminal height adjacent level disease
Time Frame
6 weeks, 12, 24, 60 Months
Title
Modified CCS
Description
CCS will be modified to include no use of a narcotic (opioids or opiates).
Time Frame
24 Month
Title
Medication Usage
Description
No use of narcotic (opioids and/or opiates)
Time Frame
24 Month
Other Pre-specified Outcome Measures:
Title
Safety Evaluation
Description
Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events, revision, additional stabilizations
Time Frame
Procedure, 6 week, 12, 24, 36, 48, 60 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Radiographic confirmation of at least moderate lumbar stenosis at one or two contiguous levels from L1-L5 that require surgical decompression. Visual Analog Scale back pain score of at least 50 mm on a 100 mm scale. Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair. 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. Skeletally mature Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%). Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures. 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: Prior fusion or decompressive laminectomy at index lumbar level. Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture). Severe facet hypertrophy that requires extensive bone removal which would cause instability. Isthmic spondylolisthesis or spondylolysis (pars fracture). Degenerative lumbar scoliosis (Cobb angle of greater than 25°). Osteoporsis or is at increased risk of osteoporosis. Back or leg pain of unknown etiology. Axial back pain only, with no leg, buttock, or groin pain. Morbid obesity defined as a body mass index > 40. Known allergy to titanium, titanium alloys, or MR contrast agents. Active or chronic infection - systemic or local. Cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellie Euler
Phone
406-924-5916
Email
eeuler@xtantmedical.com
Facility Information:
Facility Name
Desert Institute for Spinal Care (DISC)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Camoriano
Phone
602-944-2900
First Name & Middle Initial & Last Name & Degree
Nima Salari, MD
Facility Name
Hoag Orthopedics
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teddy Quilligan
Phone
855-999-4641
First Name & Middle Initial & Last Name & Degree
Jon White
First Name & Middle Initial & Last Name & Degree
Jeremy Smith
First Name & Middle Initial & Last Name & Degree
Jeffery Decky
Facility Name
Sutter Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sampreet Moneski
Phone
916-887-4736
First Name & Middle Initial & Last Name & Degree
Rudolph Schrot, MD
Facility Name
Central Cost Neurological Surgery
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Keadle, PA-C
Phone
805-704-0889
First Name & Middle Initial & Last Name & Degree
David Yeh, MD
Facility Name
Cervical Disc Center of Los Angeles
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jack Petros
Phone
424-835-0341
Email
research@inifoundation.org
First Name & Middle Initial & Last Name & Degree
Amir Vokshoor, MD
Facility Name
20_Spine Colorado, PC
City
Durango
State/Province
Colorado
ZIP/Postal Code
81301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliana Hill
Phone
970-375-3696
Email
jhill@spinecolorado.com
First Name & Middle Initial & Last Name & Degree
Douglas Orndorff, MD
Facility Name
Tallahassee Neurological Clinic
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monisha Patel
Phone
850-877-5115
Ext
248
Email
mpatel@tnc-neuro.com
First Name & Middle Initial & Last Name & Degree
Albert Lee, MD
Facility Name
01L_Northshore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Completed
Facility Name
24_Unity Surgical Center, LLC
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
25_Orthopedic Specialist of Northwest Indiana
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike Kryzskowski, PA
Phone
219-924-3300
Ext
125
Email
mkrzyskowski@osni.org
First Name & Middle Initial & Last Name & Degree
Nitin Khanna, MD
Facility Name
01_Spine Institute of Louisiana
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Individual Site Status
Terminated
Facility Name
26_St. Joseph's University Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart Changoor
Phone
908-329-5673
Email
stuartchangoor@gmail.com
First Name & Middle Initial & Last Name & Degree
Michael Faloon, MD
Facility Name
23_University Orthopaedic Associates at Great Neck
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Olivares
Phone
516-305-3219
Email
polivares@northwell.edu
First Name & Middle Initial & Last Name & Degree
Rohit Verma, MD
Facility Name
Consulting Orthopaedic Associates
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristy DuChene
Phone
419-517-7505
First Name & Middle Initial & Last Name & Degree
Thomas Andreshak, MD
Facility Name
Southern Oregon Orthpaedics
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Holte
Phone
541-779-6250
First Name & Middle Initial & Last Name & Degree
Andy Kranenburg, MD
Facility Name
Summit Spine
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kolten Paryzek
Phone
503-546-3503
First Name & Middle Initial & Last Name & Degree
Rafe Sales, MD
Facility Name
03L_Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
22_Austin Brain & Spine
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Van Schouwen
Phone
512-751-7747
Email
kelly@researchtex.com
First Name & Middle Initial & Last Name & Degree
Daniel Peterson, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Coflex PS3 Actual Conditions for Use Study

We'll reach out to this number within 24 hrs