The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology

Study Overview
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Brief Summary
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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.

Official Title
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The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology

Conditions
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Spinal Stenosis

Intervention / Treatment
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* Device: coflex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; 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: Prior fusion or decompressive laminectomy at any 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; Grade II or greater spondylolisthesis; Isthmic spondylolisthesis or spondylolysis (pars fracture); Degenerative lumbar scoliosis (Cobb angle of greater than 25°); 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; Active or chronic infection - systemic or local; Known allergy to titanium alloys or magnetic resonance imaging (MRI) contrast agents; Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction; Vulnerable population including pregnant women, prisoners, students and employees of treating physicians, and others who can be subject to coercion; Patient is unwilling to complete his/her surveys.
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stenosis patients treated with coflex<br>Patients with a primary diagnosis of lumbar spinal stenosis treated with coflex after decompression | Device: coflex<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in the Oswestry Disability Index (ODI), compared to pre-surgery | 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 | 5 years | 
| Patient has not undergone any reoperations, removals, revisions, or supplemental fixations; | Assessment of reoperations, revisions, removals, or supplemental fixation associated with the coflex device. | 5 years | 
| Patient has not had any major device related complications | 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. | 5 years | 
| Patient has not undergone any Epidural injections | Assessment of lumbar epidural injections | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Zurich Claudication Questionnaire (ZCQ) | ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. | 5 years | 
| Quality of Life | Assessment of the patient's Quality of Life as measured by the Health Outcomes Survey and EQ-5D-5L | 5 years | 
| VAS Leg Pain | Change in the assessment of leg pain compared to pre-surgery as measured by a Visual Analog Scale (VAS) (on the 100mm scale). | 5 years | 
| VAS Back Pain | Change in the assessment of back pain compared to pre-surgery as measured by a Visual Analog Scale (VAS) (on the 100mm scale). | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coflex, interlaminar stabilization, lumbar spinal stenosis, neurogenic claudication, decompression