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

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

Recruiting Locations

Medstar Georgetown University Hospital
Washington, District of Columbia 20007
Contact:
Victoria Kaestner
vak11@georgetown.edu

More Details

Status
Recruiting
Sponsor
RTI Surgical

Study Contact

Pahoua Lee
952-698-9930
plee@rtix.com

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.