A Study Comparing Effectiveness and Safety of SPIRA-A Anterior Lumbar Interbody Fusion Device to PEEK Anterior Lumbar Interbody Fusion Cage with rhBMP-2 in Instrumented Lumbar Fusions
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: 19-002741
Sponsor Protocol Number: SPA-2018
About this study
The purpose of this study is to evaluate if SPIRA-A Anterior Lumbar Interbody Fusion Device is equivalent in effectiveness and safety to PEEK Anterior Lumbar Interbody Fusion Cage with rhBMP-2 when used in instrumented lumbar fusions.
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 adults between 22 and 75 years old.
- Subject has completed at least 6 months non-operative or conservative therapy.
- Subject has signed and dated the informed consent prior to any study related procedures.
- Subject must have back pain with radicular symptoms as evidenced by leg pain, which has been confirmed by history and physical exam.
- Subject must have Degenerative Disc Disease confirmed by history and radiographic findings, stenosis, spondylolisthesis or scoliosis necessitating a Subject’s surgical procedure must involve disc(s) between L2 and S1.
- Planned lumbar fusion at a one level only.
- Subject is willing and able to participate in the study follow-up according to the protocol.
- Subject is willing and able to comply with postoperative management program.
Exclusion Criteria:
- Subject has a systemic infection such as AIDS, HIV, or active hepatitis.
- Subject has an autoimmune disease.
- Subject has significant metabolic disease that, in the surgeon’s opinion, might compromise bone growth such as osteoporosis, osteopenia, or osteomalacia.
- Subject has history of malignancy.
- Surgery for primary tumor, trauma or infection.
- Subject requires 2 or more levels of fusion.
- Subject has had previous spinal instrumentation or a previous interbody fusion procedure at the involved level.
- Subject has spondylolisthesis ≥ grade 2.
- If you are pregnant, plan to become pregnant or are breast feeding you cannot be in this study.
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 Arjun Sebastian, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available