Coflex PS3 Actual Conditions for Use Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Spinal Stenosis Lumbar

Intervention / Treatment
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* Device: coflex® Interlaminar Technology
* Procedure: Decompression


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: The coflex® Interlaminar Technology<br>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<br>* Decompression plus coflex® Interlaminar Technology<br>* Other names: coflex;|
| Active Comparator: Decompression<br>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<br>* Decompression alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oswestry Disability Index (ODI) | 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 | 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 | 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 | Assessment of maintenance of improvement after surgery. | 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 | 6 weeks, 12, 24, 60 Months | 
| Modified CCS | CCS will be modified to include no use of a narcotic (opioids or opiates). | 24 Month | 
| Medication Usage | No use of narcotic (opioids and/or opiates) | 24 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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moderate lumbar stenosis, neurogenic claudication, spinal stenosis, low back pain, decompression