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Spinal Implant
coflex® Interlaminar Stabilization for Spinal Stenosis (PAS003 Trial)
N/A
Recruiting
Research Sponsored by Surgalign Spine Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair.
Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 12, 24, 36, 48, 60 months
Awards & highlights
PAS003 Trial Summary
This trial found that the coflex device was effective in treating degenerative spinal stenosis and low back pain over the long term.
Who is the study for?
This trial is for adults with leg, buttock, or groin pain from spinal stenosis that eases when sitting. They must have significant back pain and disability, confirmed lumbar stenosis needing surgery, tried injections or 6 months of other treatments without relief, and be able to follow the study plan. Excluded are those with prior major spine surgeries, certain bone conditions, severe scoliosis or osteoporosis risks, titanium allergies, infections, specific neurological disorders like cauda equina syndrome.Check my eligibility
What is being tested?
The study evaluates a device called coflex® Interlaminar Technology used after decompression surgery in patients with degenerative spinal stenosis and low back pain. It's a long-term assessment over 2 and 5 years to see how well this technology works under actual use conditions as approved by the FDA.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical surgical complications such as infection risk at the surgical site; discomfort or pain; possible allergic reactions to materials if unknown allergies exist; nerve damage; bleeding; blood clots.
PAS003 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience leg or groin pain that eases when I sit or bend forward.
Select...
I experience leg, buttock, or groin pain that eases when I sit or bend forward.
Select...
My bones have stopped growing.
Select...
My back pain is severe, scoring at least 50 out of 100.
Select...
My back pain is severe, scoring at least 50 out of 100.
Select...
I have confirmed moderate spinal narrowing in my lower back needing surgery.
PAS003 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ procedure, 6 week, 12, 24, 36, 48, 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~procedure, 6 week, 12, 24, 36, 48, 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite Clinical Success (CCS)
coflex performance compared to IDE
coflex performance compared to decompression alone from ESCADA study.
Secondary outcome measures
Change in Oswestry Disability Index (ODI)
Change in Visual Analog Scale (VAS) for leg pain
Back
+4 moreOther outcome measures
Safety Evaluation
PAS003 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: The coflex® Interlaminar TechnologyExperimental Treatment1 Intervention
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.
Group II: DecompressionActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
coflex® Interlaminar Technology
2016
N/A
~5050
Find a Location
Who is running the clinical trial?
Surgalign Spine TechnologiesLead Sponsor
3 Previous Clinical Trials
5,265 Total Patients Enrolled
MCRA, LLCIndustry Sponsor
18 Previous Clinical Trials
7,423 Total Patients Enrolled
Xtant MedicalLead Sponsor
2 Previous Clinical Trials
5,015 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am mentally and physically capable of following the study's requirements.I experience leg or groin pain that eases when I sit or bend forward.I've had a lumbar injection or 6 months of care without relief.Your score on a questionnaire about how much your low back pain affects your daily activities is at least 20 out of 50 (which is 40% or higher).I experience leg, buttock, or groin pain that eases when I sit or bend forward.I've had a lumbar injection or 6 months of care without relief.I have had spine surgery at the specific lower back level.I have had spine damage due to injury or cancer.I need a lot of bone removed due to severe spine joint enlargement, which could cause instability.I have a spine curve of more than 25 degrees.I only have pain in my back, not in my legs, buttocks, or groin.My bones have stopped growing.My back pain is severe, scoring at least 50 out of 100.My back pain is severe, scoring at least 50 out of 100.I have osteoporosis or am at high risk for it.I have back or leg pain, but the cause is unknown.Your score on the Oswestry Low Back Pain Disability Questionnaire is at least 20 out of 50 (40%).You are allergic to titanium, materials made with titanium, or the dye used for MRI scans.I have a slipped vertebra or a small stress fracture in my back.My BMI is over 40, indicating morbid obesity.I have cauda equina syndrome with bowel or bladder control issues.I do not have any ongoing infections.I have confirmed moderate spinal narrowing in my lower back needing surgery.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this clinical trial still open?
"Affirmative. Clinicaltrials.gov displays that this medical trial, initially posted on September 9th 2019, is actively recruiting participants. The study requires 300 individuals to be enrolled from 8 different locations."
Answered by AI
What are the projected results from this medical experiment?
"This trial is to be conducted over the course of two years, with non-inferiority being assessed at Month 24. Secondary objectives include assessment of neurological status maintenance, improvement in quality of life (as measured by ODI), and device mobility for those receiving coflex treatment."
Answered by AI
Are there multiple sites participating in this experiment?
"This trial is available at 22_Austin Brain & Spine in Austin, 23_University Orthopaedic Associates at Great Neck in Great Neck, and 25_Orthopedic Specialist of Northwest Indiana in Munster among 8 other sites."
Answered by AI
How many participants have signed up to participate in this research endeavor?
"The study, sponsored by Surgalign Spine Technologies, necessitates 300 participants with the specified inclusion criteria. Experiments will be conducted at 22_Austin Brain & Spine in Austin Texas and 23_University Orthopaedic Associates at Great Neck in Great Neck New york."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Texas
What site did they apply to?
Tallahassee Neurological Clinic
Hoag Orthopedics
Other
22_Austin Brain & Spine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
Why did patients apply to this trial?
I have tried muscle relaxers, opioid, and physical therapy and more. i have spinal stenosis and previous treatments have not provided any lasting pain relief. My quality of life is severely impacted.
PatientReceived no prior treatments
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