Clinical Evaluation of Fortilink® TETRAfuse® Interbody Fusion Device in Subjects With Degenerative Disc Disease

Completed

Conditions studied: Degenerative Disc Disease

In brief

This is a prospective, multi-center, non-randomized post-market evaluation designed to collect and evaluate data on the safety and performance of the Fortilink IBF System with TETRAfuse 3D Technology.

Key facts

Study ID

NCT03761563

Run by

Xtant Medical

People needed

15

Starts

2019-02-13

Expected to finish

2023-12-30

Last updated by the study team

2024-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is skeletally mature and at least 18 years of age.
• The subject has degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptom at one or two contiguous levels (Fortilink-C), or the subject has DDD and ≤ Grade 1 spondylolisthesis of the lumbar spine at one or two contiguous levels (Fortilink-TS and Fortilink-L).
• Subject plans to undergo one of the following procedures:
• An anterior cervical interbody fusion at one to two continuous levels from C2-C3 to C7-T1 using autogenous or allogenic bone graft and supplemental fixation cleared and indicated for use at the proposed treatment level(s) (Fortilink-C), or
• An interbody fusion in the lumbar spine at one to two continuous levels from L1-L2 to L5-S1 using autogenous or allogenic bone graft and supplemental fixation cleared and indicated for use at the proposed treatment level(s) (Fortilink-TS and Fortilink-L).
• The subject has undergone non-operative treatment of at least six weeks (Fortilink-C) or at least six months (Fortilink-TS and Fortilink-L) prior to treatment with the IBF system.
• The subject is willing and able to provide informed consent.
• The subject is willing and able to attend the protocol required follow-up visits and examinations.

You may not qualify if…

• The subject has an active infection
• The subject has had prior fusion attempt(s) or is undergoing revision of a previously implanted system at the involved level(s).
• The subject is a worker's compensation case, in active litigation related to the procedure or is a prisoner or ward of the state.
• The subject meets one or more of the contraindications outlined in the IFU.
• The subject is pregnant, nursing, or is planning to become pregnant in the next year.
• The subject has documented evidence of current substance abuse.
• The subject has other concurrent medical condition that, in the opinion of the investigator, does not make the subject a good candidate for the study.

Where it is running

• Los Angeles Orthopedic Institute — Sherman Oaks, California, United States
• Rocky Mountain Spine Clinic — Lone Tree, Colorado, United States
• Florida Back Institute — Boca Raton, Florida, United States
• South Florida Spine & Orthopaedics — Coconut Creek, Florida, United States
• Spine Institute of South Florida — Delray Beach, Florida, United States
• Indiana Spine Center — Indianapolis, Indiana, United States
• Orthopaedic Institute of Western Kentucky — Paducah, Kentucky, United States
• OrthoBethesda — Bethesda, Maryland, United States
• ReVive Spine Center — Niagara Falls, New York, United States
• The Lindner Center for Research & Education at The Christ Hospital — Cincinnati, Ohio, United States
• Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Spine MD — North Richland Hills, Texas, United States
• Northwood Ortho-Spine — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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