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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03761563
Other study ID # 1105 CL
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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