Spinal Stenosis
Conditions
Keywords
coflex, interlaminar stabilization, lumbar spinal stenosis, neurogenic claudication, decompression
Brief summary
The purpose of the coflexCOMMUNITY observational study is to collect information on patients with spinal stenosis undergoing back surgery with the coflex® implant, and to look at their outcomes and the cost-effectiveness of this procedure.
Interventions
DEVICEcoflex
Sponsors
SPIRITT Research
Predicted, Reported and Observed Outcomes Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patient is skeletally mature and has at least moderate impairment in function, experiences relief in flexion from his/her symptoms of leg/buttocks/groin pain, with or without back pain, and has undergone at least 6 months of non-operative treatment; 2. Patient is treated surgically at 1 or 2 contiguous lumbar motion segments with the coflex Interlaminar Device from L1-L5 after decompression of stenosis at the affected level(s), where such use is not contraindicated as noted below.
Exclusion criteria
1. Prior fusion or decompressive laminectomy at any 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. Grade II or greater spondylolisthesis; 5. Isthmic spondylolisthesis or spondylolysis (pars fracture); 6. Degenerative lumbar scoliosis (Cobb angle of greater than 25°); 7. Osteoporosis; 8. Back or leg pain of unknown etiology; 9. Axial back pain only, with no leg, buttock, or groin pain; 10. Morbid obesity defined as a body mass index \> 40; 11. Active or chronic infection - systemic or local; 12. Known allergy to titanium alloys or magnetic resonance imaging (MRI) contrast agents; 13. Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction; 14. Vulnerable population including pregnant women, prisoners, students and employees of treating physicians, and others who can be subject to coercion; 15. Patient is unwilling to complete his/her surveys.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient has not undergone any Epidural injections | 5 years | Assessment of lumbar epidural injections |
| Improvement in the Oswestry Disability Index (ODI), compared to pre-surgery | 5 years | The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI). It will be assessed if the improvement in ODI since the pre-surgery status is at least 15 points |
| Patient has not undergone any reoperations, removals, revisions, or supplemental fixations; | 5 years | Assessment of reoperations, revisions, removals, or supplemental fixation associated with the coflex device. |
| Patient has not had any major device related complications | 5 years | Assessment of major device-related complications, including but not limited to permanent new or increasing sensory or motor deficit at 2 years and 5 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Zurich Claudication Questionnaire (ZCQ) | 5 years | ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. |
| Quality of Life | 5 years | Assessment of the patient's Quality of Life as measured by the Health Outcomes Survey and EQ-5D-5L |
| VAS Leg Pain | 5 years | Change in the assessment of leg pain compared to pre-surgery as measured by a Visual Analog Scale (VAS) (on the 100mm scale). |
| VAS Back Pain | 5 years | Change in the assessment of back pain compared to pre-surgery as measured by a Visual Analog Scale (VAS) (on the 100mm scale). |
Countries
United States
Outcome results
None listed