A Study to Evaluate the Safety and Effectiveness of the Spineology Interbody Fusion System in Lumbar Fusion Procedures

Overview

  • Study type

    Interventional
  • Study phase

    I
  • Study IDs

  • Describes 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.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mohamad Bydon, M.D.

Open for enrollment

Contact information:

Sandy Goncalves

(507)538-6546

Goncalves.Sandy@mayo.edu

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CLS-20304026

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