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

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 weeks of 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 spondylolisthesis or scoliosis necessitating a Subject’s surgical procedure must involve disc(s) between L2 and S1.
  • Planned lumbar fusion at a one or two levels 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 3 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.

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

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20473848

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