Status:
COMPLETED
Clinical Evaluation of Fortilink® TETRAfuse® Interbody Fusion Device in Subjects With Degenerative Disc Disease
Lead Sponsor:
Xtant Medical
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18+ years
Brief Summary
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
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 13 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03761563
Start Date
February 13 2019
End Date
December 30 2023
Last Update
March 15 2024
Active Locations (14)
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1
Los Angeles Orthopedic Institute
Sherman Oaks, California, United States, 91403
2
Rocky Mountain Spine Clinic
Lone Tree, Colorado, United States, 80124
3
Florida Back Institute
Boca Raton, Florida, United States, 33496
4
South Florida Spine & Orthopaedics
Coconut Creek, Florida, United States, 33073