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

Overview

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

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20304026

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