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

Degenerative Disc Disease Clinical Trial

— FORTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761563
• Other study ID #: 1105 CL
• Status: Completed
• Start date: February 13, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2024
• Source: Xtant Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Diseases

Intervention

Device:
• Fortilink IBF System with TETRAfuse Technology
Cervical and lumbar fusion

Locations

Country	Name	City	State
United States	OrthoBethesda	Bethesda	Maryland
United States	Florida Back Institute	Boca Raton	Florida
United States	The Lindner Center for Research & Education at The Christ Hospital	Cincinnati	Ohio
United States	South Florida Spine & Orthopaedics	Coconut Creek	Florida
United States	Spine Institute of South Florida	Delray Beach	Florida
United States	Indiana Spine Center	Indianapolis	Indiana
United States	Rocky Mountain Spine Clinic	Lone Tree	Colorado
United States	ReVive Spine Center	Niagara Falls	New York
United States	Spine MD	North Richland Hills	Texas
United States	Orthopaedic Institute of Western Kentucky	Paducah	Kentucky
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Los Angeles Orthopedic Institute	Sherman Oaks	California
United States	Northwood Ortho-Spine	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Xtant Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of cervical fusion evaluated by radiographic evidence		12 months
Primary	Rate of lumbar fusion evaluated by radiographic evidence		24 months
Secondary	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
Secondary	Radiographic findings by CT evaluation		12 months and 24 months
Secondary	Time to return to work		up to 24 months
Secondary	Incidence of serious device related adverse events		up to 24 months
Secondary	Incidence of serious procedure related adverse events		up to 24 months
Secondary	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
Secondary	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
Secondary	Change in pain medication usage from baseline		1 month, 3 months, 6 months, 12 months, and 24 months