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

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

Clinical Trials