Clinical trial NCT03761563: Clinical Evaluation of Fortilink® TETRAfuse® Interbody Fusion Device in Subjects With Degenerative Disc Disease
Official title: Clinical Evaluation of Fortilink® TETRAfuse® Interbody Fusion Device in Subjects With Degenerative Disc Disease (FORTE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Lead sponsor: Xtant Medical
Sponsor class: INDUSTRY
First posted: 2018-12-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects in this study will be candidates who undergo interbody fusion of hte spine due to degenerative disc disease using the Fortilink IBF device.

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of cervical fusion evaluated by radiographic evidence
timeFrame: 12 months
measure: Rate of lumbar fusion evaluated by radiographic evidence
timeFrame: 24 months
Secondary outcomes:
measure: Change in pain from baseline evaluated by use of subject-reported 100mm Visual Analogue Scale (VAS)
timeFrame: 1 month, 3 months, 6 months, 12 months, and 24 months
measure: Radiographic findings by CT evaluation
timeFrame: 12 months and 24 months
measure: Time to return to work
timeFrame: up to 24 months
measure: Incidence of serious device related adverse events
timeFrame: up to 24 months
measure: Incidence of serious procedure related adverse events
timeFrame: up to 24 months
measure: Change in functional ability determined by Neck Disability Index (NDI) or Oswestry Disability Index (ODI)
timeFrame: 3 months, 6 months, 12 months, and 24 months
measure: Change in quality of life determined by SF-12 questionnaire
timeFrame: 3 months, 6 months, 12 months, and 24 months
measure: Change in pain medication usage from baseline
timeFrame: 1 month, 3 months, 6 months, 12 months, and 24 months
Other outcomes:
Locations:
city: Sherman Oaks
country: United States
facility: Los Angeles Orthopedic Institute
state: California
city: Lone Tree
country: United States
facility: Rocky Mountain Spine Clinic
state: Colorado
city: Boca Raton
country: United States
facility: Florida Back Institute
state: Florida
city: Coconut Creek
country: United States
facility: South Florida Spine & Orthopaedics
state: Florida
city: Delray Beach
country: United States
facility: Spine Institute of South Florida
state: Florida
city: Indianapolis
country: United States
facility: Indiana Spine Center
state: Indiana
city: Paducah
country: United States
facility: Orthopaedic Institute of Western Kentucky
state: Kentucky
city: Bethesda
country: United States
facility: OrthoBethesda
state: Maryland
city: Niagara Falls
country: United States
facility: ReVive Spine Center
state: New York
city: Cincinnati
country: United States
facility: The Lindner Center for Research & Education at The Christ Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: North Richland Hills
country: United States
facility: Spine MD
state: Texas
city: The Woodlands
country: United States
facility: Northwood Ortho-Spine
state: Texas
Study officials:
References: