Degenerative Disc DiseaseFORTENCT03761563
Clinical Evaluation of Fortilink® TETRAfuse® Interbody Fusion Device in Subjects With Degenerative Disc Disease
An observational study of Degenerative Disc Disease, run by Xtant Medical at 14 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Fortilink IBF System with TETRAfuse Technology
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 14 sitesUnited States
- Study dates
- 13 Feb 2019to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
OrthoBethesda
Bethesda, Maryland, 20817
Florida Back Institute
Boca Raton, Florida, 33496
The Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, 45219
South Florida Spine & Orthopaedics
Coconut Creek, Florida, 33073
Spine Institute of South Florida
Delray Beach, Florida, 33484
Indiana Spine Center
Indianapolis, Indiana, 47905
Rocky Mountain Spine Clinic
Lone Tree, Colorado, 80124
ReVive Spine Center
Niagara Falls, New York, 14304
Spine MD
North Richland Hills, Texas, 76182
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42001
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Los Angeles Orthopedic Institute
Sherman Oaks, California, 91403
Northwood Ortho-Spine
The Woodlands, Texas, 77382
About this study
Official title: 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.
Read the 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).
- Conditions
- Degenerative Disc Disease
- Being tested
- Fortilink IBF System with TETRAfuse Technology
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortilink IBF System with TETRAfuse TechnologyDevice
Cervical and lumbar fusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cervical fusion evaluated by radiographic evidence
Measured: 12 months
Rate of lumbar fusion evaluated by radiographic evidence
Measured: 24 months
Secondary outcomes (8)
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.
Measured: 1 month, 3 months, 6 months, 12 months, and 24 months
Radiographic findings by CT evaluation
Measured: 12 months and 24 months
Time to return to work
Measured: up to 24 months
Incidence of serious device related adverse events
Measured: up to 24 months
Incidence of serious procedure related adverse events
Measured: 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.
Measured: 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.
Measured: 3 months, 6 months, 12 months, and 24 months
Change in pain medication usage from baseline
Measured: 1 month, 3 months, 6 months, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start13 Feb 2019
- Primary completion30 Jun 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xtant Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761563
- Sponsor's protocol ID
- 1105 CL
- Acronym
- FORTE
- Status last verified
- Mar 2024
- First submitted
- 29 Nov 2018
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Fortilink® TETRAfuse® Interbody Fusion Device in Subjects With Degenerative Disc Disease (FORTE)
- ClinicalTrials.gov ID
- NCT03761563
- Acronym / sponsor ID
- FORTE / 1105 CL
- Conditions
- Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Xtant MedicalIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fortilink IBF System with TETRAfuse TechnologyCervical and lumbar fusion | Device | – |
Primary outcome
Rate of cervical fusion evaluated by radiographic evidence
Time frame: 12 months
Rate of lumbar fusion evaluated by radiographic evidence
Time frame: 24 months
8 secondary outcomes
Change in pain from baseline evaluated by use of subject-reported 100mm Visual Analogue Scale (VAS)
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Radiographic findings by CT evaluation
Time frame: 12 months and 24 months
Time to return to work
Time frame: up to 24 months
Incidence of serious device related adverse events
Time frame: up to 24 months
Incidence of serious procedure related adverse events
Time frame: up to 24 months
Change in functional ability determined by Neck Disability Index (NDI) or Oswestry Disability Index (ODI)
Time frame: 3 months, 6 months, 12 months, and 24 months
Change in quality of life determined by SF-12 questionnaire
Time frame: 3 months, 6 months, 12 months, and 24 months
Change in pain medication usage from baseline
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by Xtant Medical at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of cervical fusion evaluated by radiographic evidence (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.