Spinal Stenosis LumbarPAS003NCT02555280
Coflex PS3 Actual Conditions for Use Study
A study testing coflex® Interlaminar Technology and Decompression in people with Spinal Stenosis Lumbar, run by Companion Spine, LLC at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Stenosis Lumbar
- What is being tested?
- coflex® Interlaminar Technology and Decompression
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 14 sitesUnited States
- Study dates
- 9 Sep 2019to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
UC Health Spine Center
Aurora, Colorado, 80045
Austin Neurosurgeons
Austin, Texas, 78746
01L_Northshore University Health System
Evanston, Illinois, 60201
Northwell Health Physician Partners Orthopaedic Institute at Great Neck
Great Neck, New York, 11021
24_Unity Surgical Center, LLC
Lafayette, Indiana, 47905
Southern Oregon Orthpaedics
Medford, Oregon, 97504
03L_Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Desert Institute for Spine Care (DISC)
Phoenix, Arizona, 85020
Summit Spine
Portland, Oregon, 97225
Sutter Health
Sacramento, California, 95816
Central Cost Neurological Surgery
San Luis Obispo, California, 93401
Cervical Disc Center of Los Angeles
Santa Monica, California, 90404
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308
About this study
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.
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.
Read the 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.
- Conditions
- Spinal Stenosis Lumbar
- Being tested
- coflex® Interlaminar Technology, Decompression
- Keywords
- moderate lumbar stenosis, neurogenic claudication, spinal stenosis, low back pain, decompression
- Medical subject headings
- Spinal Stenosis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coflex® Interlaminar TechnologyDevice
Also called coflex
Decompression plus coflex® Interlaminar Technology
DecompressionProcedure or surgery
Decompression alone
| Study group | Role | What they receive |
|---|---|---|
| The coflex® Interlaminar Technology | Other | 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. Receives: Device: coflex® Interlaminar Technology |
| Decompression | Active comparator | 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. Receives: Procedure: Decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
coflex performance compared to IDE
Evaluation of coflex device performance in conjunction with surgical decompression in an actual conditions of use study.
Measured: 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.
Measured: 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
Measured: 24 Month
Secondary outcomes (7)
Change in Oswestry Disability Index (ODI)
Quality of life as determined by ODI. In terms of achieving at least a 15 point improvement.
Measured: Baseline, 24 and 60 months
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.
Measured: Baseline, 24 and 60 Months
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.
Measured: Baseline, 24 and 60 Months
Neurological Status
Assessment of maintenance of improvement after surgery.
Measured: Baseline, 6 weeks, 12, 24, 36, 48, 60 Months
Radiographic Assessments
- Significant migration or complete expulsion of implant
- Spinous process fracture
- Maintenance of foraminal height
- adjacent level disease
Measured: 6 weeks, 12, 24, 60 Months
Modified CCS
CCS will be modified to include no use of a narcotic (opioids or opiates).
Measured: 24 Month
Medication Usage
No use of narcotic (opioids and/or opiates)
Measured: 24 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study start9 Sep 2019
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Stenosis LumbarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Companion Spine, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- MCRA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555280
- Sponsor's protocol ID
- PS3/P110008
- Acronym
- PAS003
- Status last verified
- Jun 2026
- First submitted
- 2 Sep 2015
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02555280
- Acronym / sponsor ID
- PAS003 / PS3/P110008
- Conditions
- Spinal Stenosis Lumbar
- Keywords
- moderate lumbar stenosis, neurogenic claudication, spinal stenosis, low back pain, decompression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Companion Spine, LLCUniversity, hospital or other
- Collaborators
- MCRA
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 21 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The coflex® Interlaminar Technology | Other | Device: coflex® Interlaminar TechnologyThe 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 comparator | Procedure: DecompressionLumbar 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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°).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coflex® Interlaminar TechnologyAlso: coflexDecompression plus coflex® Interlaminar Technology | Device | The coflex® Interlaminar Technology |
| DecompressionDecompression alone | Procedure or surgery | Decompression |
Primary outcome
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.
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.
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
7 secondary outcomes
Change in Oswestry Disability Index (ODI)
Time frame: Baseline, 24 and 60 months
Change in Visual Analog Scale (VAS) for low back pain
Time frame: Baseline, 24 and 60 Months
Change in Visual Analog Scale (VAS) for leg pain
Time frame: Baseline, 24 and 60 Months
Neurological Status
Time frame: Baseline, 6 weeks, 12, 24, 36, 48, 60 Months
Radiographic Assessments
Time frame: 6 weeks, 12, 24, 60 Months
Modified CCS
Time frame: 24 Month
Medication Usage
Time frame: 24 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coflex® Interlaminar Technology and Decompression in people with Spinal Stenosis Lumbar, run by Companion Spine, LLC at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
coflex performance compared to IDE (time frame: 24and 60 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.