Research Source
The purpose of this study is to evaluate enhancement patterns in magnetic resonance imaging (MRI) evidence following the use of VersaWrap in bilateral lumbar decompression surgeries.
This study is a prospective, post-market, observational multi-center evaluation of the use of VersaWrap. Patients identified by the Investigator in their practice as needing a bilateral lumbar decompression at one level (L4-S1) and meeting all the inclusion and none of the exclusion criteria. Patients will consent to participating in the study, prior to any study procedures.
Inclusion Criteria: 1. Patients aged ≥18 and ≤65 at time of surgery 2. Patients undergoing lumbar decompression bilaterally at one level from L4-S1 3. Psychologically, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule, study requirements with a signed informed consent. Exclusion Criteria: 1. Non-English speaking 2. Known allergy or sensitivity to citrate, alginate or hyaluronate 3. Known allergy or sensitivity to MRI contrast dye 4. Known to experience claustrophobia 5. Pregnant or breastfeeding at time of surgery 6. Incarcerated at tim…
VersaWrap Nerve Protector is applied to the nerve root to protect the surrounding tissues
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