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

NCT03761563 | Completed

• 1 other identifier: 1105 CL
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 14

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.

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (2)

• Rate of cervical fusion evaluated by radiographic evidence

  12 months

• Rate of lumbar fusion evaluated by radiographic evidence

  24 months

Secondary Outcomes (8)

• Change in pain from baseline evaluated by use of subject-reported 100mm Visual Analogue Scale (VAS)

  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

Interventions

Fortilink IBF System with TETRAfuse Technology DEVICE

Cervical and lumbar fusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xtant Medical: lead

Study Sites (14)

Los Angeles Orthopedic Institute

Sherman Oaks, California, 91403, United States

Location

Rocky Mountain Spine Clinic

Lone Tree, Colorado, 80124, United States

Location

Florida Back Institute

Boca Raton, Florida, 33496, United States

Location

South Florida Spine & Orthopaedics

Coconut Creek, Florida, 33073, United States

Location

Spine Institute of South Florida

Delray Beach, Florida, 33484, United States

Location

Indiana Spine Center

Indianapolis, Indiana, 47905, United States

Location

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001, United States

Location

OrthoBethesda

Bethesda, Maryland, 20817, United States

Location

ReVive Spine Center

Niagara Falls, New York, 14304, United States

Location

The Lindner Center for Research & Education at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Spine MD

North Richland Hills, Texas, 76182, United States

Location

Northwood Ortho-Spine

The Woodlands, Texas, 77382, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 3, 2018
• Study Start: February 13, 2019
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

US (14)