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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Clinical Evaluation of Fortilink® TETRAfuse® Interbody Fusion Device in Subjects With Degenerative Disc Disease (FORTE)

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: Fortilink IBF System with TETRAfuse Technology


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Fortilink IBF System with TETRAfuse Technology|Cervical and lumbar fusion|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cervical fusion evaluated by radiographic evidence |  | 12 months | 
| Rate of lumbar fusion evaluated by radiographic evidence |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain from baseline evaluated by use of subject-reported 100mm Visual Analogue Scale (VAS) | The VAS pain scale ranges from 0 to 100 where 0 represents No Pain and 100 represents Unbearable Pain. | 1 month, 3 months, 6 months, 12 months, and 24 months | 
| Radiographic findings by CT evaluation |  | 12 months and 24 months | 
| Time to return to work |  | up to 24 months | 
| Incidence of serious device related adverse events |  | up to 24 months | 
| Incidence of serious procedure related adverse events |  | up to 24 months | 
| Change in functional ability determined by Neck Disability Index (NDI) or Oswestry Disability Index (ODI) | The NDI is a subject questionnaire designed to assess neck pain and will only be completed by subjects who undergo cervical implants. The ODI is a subject questionnaire designed to assess back pain and will only be completed by subjects who undergo lumbar implants. Each questionnaire consists of a total score ranging from 0 to 100 where a lower score represents a better outcome and a higher score represents a worse outcome. | 3 months, 6 months, 12 months, and 24 months | 
| Change in quality of life determined by SF-12 questionnaire | SF-12 questionnaires scores are computed and range from 0 to 100 where a 0 score indicates the lowest level of health and 100 indicates the highest level of health. | 3 months, 6 months, 12 months, and 24 months | 
| Change in pain medication usage from baseline |  | 1 month, 3 months, 6 months, 12 months, and 24 months |