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

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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: Fortilink IBF System with TETRAfuse 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).

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • California
    • Sherman Oaks, California, United States, 91403
      • Los Angeles Orthopedic Institute
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Rocky Mountain Spine Clinic
  • Florida
    • Boca Raton, Florida, United States, 33496
      • Florida Back Institute
    • Coconut Creek, Florida, United States, 33073
      • South Florida Spine & Orthopaedics
    • Delray Beach, Florida, United States, 33484
      • Spine Institute of South Florida
  • Indiana
    • Indianapolis, Indiana, United States, 47905
      • Indiana Spine Center
  • Kentucky
    • Paducah, Kentucky, United States, 42001
      • Orthopaedic Institute of Western Kentucky
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • OrthoBethesda
  • New York
    • Niagara Falls, New York, United States, 14304
      • ReVive Spine Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Lindner Center for Research & Education at The Christ Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Texas
    • North Richland Hills, Texas, United States, 76182
      • Spine MD
    • The Woodlands, Texas, United States, 77382
      • Northwood Ortho-Spine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of cervical fusion evaluated by radiographic evidence	12 months
Rate of lumbar fusion evaluated by radiographic evidence	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Radiographic findings by CT evaluation		12 months and 24 months
Time to return to work		up to 24 months
Incidence of serious device related adverse events		up to 24 months
Incidence of serious procedure related adverse events		up to 24 months
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
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
Change in pain medication usage from baseline		1 month, 3 months, 6 months, 12 months, and 24 months

Collaborators and Investigators

• Sponsor: Xtant Medical

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2019
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Intervertebral Disc Degeneration; Spinal Diseases
• Other Study ID Numbers: 1105 CL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No