Lumbar degenerative disc disease/ spinal stenosis
Conditions
Interventions
All patients will be planned for spine surgery in which the Valeo or the PEEk
cage is used. Patient will be followed for 2-years (3 months, 6 months, 12
months and 24 months) for CT scans and to com
Sponsors
Amedica Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: _Subjects must be 18-75 years old. _ at least 6 months of back pain/leg pain _Grade 3 or higher disc degeneration on the MRI (by the Pfirrmann classification) with or without nerve root compression
Exclusion criteria
Exclusion criteria: •Osteoporosis •Patients with prior failed fusion at the same level •Degenerative scoliosis •Degenerative spondylolisthesis greater than Grade II •Pregnancy •Psychiatric or mental disease •Alcoholism (drinking more than 5 units per day) •Active infection or prior infection at the surgical site •Active cancer •Insufficient language skills to complete questionnaires •Participation in another study •More than two symptomatic levels that need fusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint Disability as measured with the MRDQ. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoint Fusion rate will be evaluated by comparing flexion and extension radiographs correlated to clinical improvements on the MRQD/SF-36 and VAS. Fusion quality will be verified with a CT scan at 12 months | — |
Countries
Netherlands
Outcome results
None listed