Coflex PS3 Actual Conditions for Use Study
PAS003
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.
1 other identifier
interventional
40
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2015
CompletedFirst Posted
Study publicly available on registry
September 21, 2015
CompletedStudy Start
First participant enrolled
September 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
CompletedJuly 2, 2026
June 1, 2026
6.7 years
September 2, 2015
June 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
coflex performance compared to IDE
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.
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)
* 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 Outcomes (7)
Change in Oswestry Disability Index (ODI)
Baseline, 24 and 60 months
Change in Visual Analog Scale (VAS) for low back pain
Baseline, 24 and 60 Months
Change in Visual Analog Scale (VAS) for leg pain
Baseline, 24 and 60 Months
Neurological Status
Baseline, 6 weeks, 12, 24, 36, 48, 60 Months
Radiographic Assessments
6 weeks, 12, 24, 60 Months
- +2 more secondary outcomes
Other Outcomes (1)
Safety Evaluation
Procedure, 6 week, 12, 24, 36, 48, 60 Months
Study Arms (2)
The coflex® Interlaminar Technology
OTHERThe 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.
Decompression
ACTIVE COMPARATORLumbar 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.
Interventions
Decompression plus coflex® Interlaminar Technology
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MCRAcollaborator
- Companion Spine, LLClead
Study Sites (14)
Desert Institute for Spine Care (DISC)
Phoenix, Arizona, 85020, United States
Sutter Health
Sacramento, California, 95816, United States
Central Cost Neurological Surgery
San Luis Obispo, California, 93401, United States
Cervical Disc Center of Los Angeles
Santa Monica, California, 90404, United States
UC Health Spine Center
Aurora, Colorado, 80045, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308, United States
01L_Northshore University Health System
Evanston, Illinois, 60201, United States
24_Unity Surgical Center, LLC
Lafayette, Indiana, 47905, United States
Spine Institute of Louisiana
Shreveport, Louisiana, 71101, United States
Northwell Health Physician Partners Orthopaedic Institute at Great Neck
Great Neck, New York, 11021, United States
Southern Oregon Orthpaedics
Medford, Oregon, 97504, United States
Summit Spine
Portland, Oregon, 97225, United States
03L_Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Austin Neurosurgeons
Austin, Texas, 78746, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2015
First Posted
September 21, 2015
Study Start
September 9, 2019
Primary Completion
May 31, 2026
Study Completion
May 31, 2026
Last Updated
July 2, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share