Spinal Stenosis Lumbar
Conditions
Keywords
moderate lumbar stenosis, neurogenic claudication, spinal stenosis, low back pain, decompression
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.
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.
Interventions
Decompression plus coflex® Interlaminar Technology
PROCEDUREDecompression
Decompression alone
Sponsors
MCRA
Xtant Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Radiographic confirmation of at least moderate lumbar stenosis at one or two contiguous levels from L1-L5 that require surgical decompression. 2. Visual Analog Scale back pain score of at least 50 mm on a 100 mm scale. 3. Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair. 4. 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. 5. Skeletally mature 6. Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%). 7. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures. 8. 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
1. Prior fusion or decompressive laminectomy at index lumbar level. 2. Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture). 3. Severe facet hypertrophy that requires extensive bone removal which would cause instability. 4. Isthmic spondylolisthesis or spondylolysis (pars fracture). 5. Degenerative lumbar scoliosis (Cobb angle of greater than 25°). 6. Osteoporsis or is at increased risk of osteoporosis. 7. Back or leg pain of unknown etiology. 8. Axial back pain only, with no leg, buttock, or groin pain. 9. Morbid obesity defined as a body mass index \> 40. 10. Known allergy to titanium, titanium alloys, or MR contrast agents. 11. Active or chronic infection - systemic or local. 12. Cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Clinical Success (CCS) | 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 |
| coflex performance compared to IDE | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Scale (VAS) for leg pain | Baseline, 24 and 60 Months | Leg pain reduction evaluated by use of VAS for leg pain. In terms of achieving at least a 20 point improvement. |
| Neurological Status | Baseline, 6 weeks, 12, 24, 36, 48, 60 Months | Assessment of maintenance of improvement after surgery. |
| Modified CCS | 24 Month | CCS will be modified to include no use of a narcotic (opioids or opiates). |
| Medication Usage | 24 Month | No use of narcotic (opioids and/or opiates) |
| Radiographic Assessments | 6 weeks, 12, 24, 60 Months | * Significant migration or complete expulsion of implant * Spinous process fracture * Maintenance of foraminal height * adjacent level disease |
| Change in Oswestry Disability Index (ODI) | Baseline, 24 and 60 months | Quality of life as determined by ODI. In terms of achieving at least a 15 point improvement. |
| Change in Visual Analog Scale (VAS) for low back pain | Baseline, 24 and 60 Months | Low back pain reduction evaluated by use of VAS for back pain. In terms of achieving at least a 20 point improvement. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Evaluation | Procedure, 6 week, 12, 24, 36, 48, 60 Months | Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events, revision, additional stabilizations |
Countries
United States
Contacts
Primary ContactLaura Henderson
Backup ContactIsabella Rosales
Outcome results
None listed