Clinical Study of the Valeo OL Interbody Fusion Device for Posterior Lumbar Interbody fusion versus PEEK: the Silicon Nitride and PEEK (SNAP) trial.
Phase 4
Completed
- Conditions
- Lumbar degenerative disc disease/ spinal stenosis10005944
- Registration Number
- NL-OMON36245
- Lead Sponsor
- Amedica Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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
•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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint<br /><br>Disability as measured with the MRDQ.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Endpoint<br /><br>Fusion rate will be evaluated by comparing flexion and extension radiographs<br /><br>correlated to clinical improvements on the MRQD/SF-36 and VAS. Fusion quality<br /><br>will be verified with a CT scan at 12 months</p><br>