Coflex PS3 Actual Conditions for Use Study (PAS003)
Spinal Stenosis Lumbar
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
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.
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
Other
Active Comparator
The coflex® Interlaminar Technology
Decompression
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.