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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-13

Study Completion Date

2023-12-30

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.

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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).

Conditions

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Degenerative Disc Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Fortilink IBF System with TETRAfuse Technology

Cervical and lumbar fusion

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No