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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Decompression plus coflex® Interlaminar Technology
Decompression alone
Desert Institute for Spine Care (DISC)
Phoenix, Arizona, United States
coflex performance compared to IDE
Evaluation of coflex device performance in conjunction with surgical decompression in an actual conditions of use study.
Time frame: 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.
Time frame: 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
Time frame: 24 Month
Change in Oswestry Disability Index (ODI)
Quality of life as determined by ODI. In terms of achieving at least a 15 point improvement.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 24 and 60 Months
Neurological Status
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Hoag Orthopedics
Irvine, California, United States
WITHDRAWNSutter Health
Sacramento, California, United States
RECRUITINGCentral Cost Neurological Surgery
San Luis Obispo, California, United States
RECRUITINGCervical Disc Center of Los Angeles
Santa Monica, California, United States
RECRUITINGUC Health Spine Center
Aurora, Colorado, United States
RECRUITINGMercy Regional Medical Center
Durango, Colorado, United States
WITHDRAWNTallahassee Neurological Clinic
Tallahassee, Florida, United States
TERMINATED01L_Northshore University Health System
Evanston, Illinois, United States
COMPLETED24_Unity Surgical Center, LLC
Lafayette, Indiana, United States
TERMINATED...and 9 more locations
Assessment of maintenance of improvement after surgery.
Time frame: 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
Time frame: 6 weeks, 12, 24, 60 Months
Modified CCS
CCS will be modified to include no use of a narcotic (opioids or opiates).
Time frame: 24 Month
Medication Usage
No use of narcotic (opioids and/or opiates)
Time frame: 24 Month