Spineology Clinical Outcomes Trial: An IDE Investigation

Completed · Not applicable

Conditions studied: Lumbar Degenerative Disc Disease

In brief

This study evaluated the safety and effectiveness of the Spineology Interbody Fusion System (SIFS) in an instrumented interbody lumbar fusion in subjects presenting with symptomatic single-level lumbar degenerative disc disease.

Key facts

Study ID

NCT02347410

Run by

Spineology, Inc

People needed

102

Starts

2015-01-22

Expected to finish

2020-03-04

Last updated by the study team

2021-10-20

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Skeletally mature;
• Confirmed symptomatic single-level lumbar degenerative disc disease (DDD) between L2 and S1;
• Minimum low back Visual Analog Scale (VAS) pain score of 40mm;
• Minimum Oswestry Disability Index (ODI) score of 40;
• Received at least 6-months of conservative care; and
• Willing and able to comply with protocol evaluations and provide informed consent.

You may not qualify if…

• 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, pregnant or contemplating pregnancy during follow-up period; or
• Enrolled in a concurrent clinical investigation that may confound the findings of the current investigation

Where it is running

• Florida Orthopaedic Associates — DeLand, Florida, United States
• Spine Institute of Louisiana — Shreveport, Louisiana, United States
• Thibodaux Regional Medical Center — Thibodaux, Louisiana, United States
• Georgetown University Hospital — Clinton, Maryland, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Sports Medicine North — Peabody, Massachusetts, United States
• Bronson Healthcare Methodist Hospital - Neuroscience Center — Kalamazoo, Michigan, United States
• Mayo Clinic Hospital - College of Medicine — Rochester, Minnesota, United States
• University at Buffalo/SUNY — Buffalo, New York, United States
• University of Vermont Medical Center — South Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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