Clinical Evaluation of Fortilink® TETRAfuse® Interbody Fusion Device in Subjects With Degenerative Disc Disease
Purpose
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.
Condition
- Degenerative Disc Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
More Details
- Status
- Completed
- Sponsor
- Xtant Medical
Study Contact
Detailed Description
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. There will be 3 arms in the study, one for each configuration of the Fortilink IBF system (Fortilink-C, Fortilink-TS and Fortilink-L). Up to 50 subjects will be enrolled in each study arm for a total of up to 150 subjects at up to 20 sites in the United States (US) and European Union (EU).