A Study to Evaluate the Safety and Effectiveness of the Spineology Interbody Fusion System in Lumbar Fusion Procedures
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-000751
NCT ID: NCT02347410
Sponsor Protocol Number: 62-180
About this study
The purpose of this study is to evaluate the safety and effectiveness of the Spineology Interbody Fusion System (SIFS) mesh device when implanted in the spinal vertebrae disc space during a lumbar fusion procedure.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Skeletally mature
- Confirmed symptomatic single-level lumbar degenerative disc disease between L2 and S1
- Minimum low back VAS pain score of 40mm
- Minimum ODI score of 40
- Received at least 6-months of conservative care
- Willing and able to comply with protocol evaluations
- Provides informed consent
Exclusion Criteria
- Previous fusion or total disc replacement at the index level
- Greater than Grade I spondylolisthesis
- Has symptomatic multi-level lumbar DDD
- Active systemic infection or infection at the local surgical site
- Active or suspected malignancy
- Body Mass Index of greater than or equal to 40
- Significant metabolic bone disease
- Taking medication known to interfere with bone healing
- Has a current substance abuse disorder
- Has a somatoform, dissociative, eating or psychotic disorder
- Waddell Signs of inorganic behavior
- Current tobacco user
- Is a prisoner
- If female is pregnant or contemplating pregnancy during follow-up period
- Enrolled in a concurrent clinical investigation that may confound the findings of the current investigation
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Mohamad Bydon, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available