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

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ClinicalTrials.gov Identifier: NCT03761563
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
RTI Surgical

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.

Condition or disease Intervention/treatment
Degenerative Disc Disease 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).


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of Fortilink® TETRAfuse® Interbody Fusion Device in Subjects With Degenerative Disc Disease (FORTE)
Actual Study Start Date : February 13, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Rate of cervical fusion evaluated by radiographic evidence [ Time Frame: 3 months ]
  2. Rate of lumbar fusion evaluated by radiographic evidence [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Rate of progression of fusion evaluated by radiographic evidence [ Time Frame: 1 month, 3 months, 6 months, 12 months, and 24 months ]
  2. 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 ]
    The VAS pain scale ranges from 0 to 100 where 0 represents No Pain and 100 represents Unbearable Pain.

  3. Rate of maintenance of functional spine unit (FSU) height evaluated by radiographic evidence [ Time Frame: 1 month, 3 months, 6 months, 12 months, and 24 months ]
  4. Radiographic findings [ Time Frame: 1 month, 3 months, 6 months, 12 months, and 24 months ]
  5. Time to return to work [ Time Frame: 1 month, 3 months, 6 months, 12 months, and 24 months ]
  6. Incidence of serious device related adverse events [ Time Frame: up to 24 months ]
  7. Incidence of serious procedure related adverse events [ Time Frame: up to 24 months ]
  8. 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 ]
    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.

  9. Change in quality of life determined by SF-12 questionnaire [ Time Frame: 3 months, 6 months, 12 months, and 24 months ]
    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.

  10. Change in pain medication usage from baseline [ Time Frame: 1 month, 3 months, 6 months, 12 months, and 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761563


Contacts
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Contact: Pahoua Lee 952-698-9930 plee@rtix.com
Contact: Megan O'Toole 952-698-9944 motoole@rtix.com

Locations
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United States, Florida
Florida Back Institute Recruiting
Boca Raton, Florida, United States, 33496
Contact: Caroline Rangel         
Spine Institute of South Florida Recruiting
Delray Beach, Florida, United States, 33484
Contact: Bianca Orfanos         
United States, Kentucky
Orthopaedic Institute of Western Kentucky Recruiting
Paducah, Kentucky, United States, 42001
Contact: Becky Vinson         
United States, Maryland
OrthoBethesda Recruiting
Bethesda, Maryland, United States, 20817
Contact: Armandi Smith         
Sponsors and Collaborators
RTI Surgical

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Responsible Party: RTI Surgical
ClinicalTrials.gov Identifier: NCT03761563     History of Changes
Other Study ID Numbers: 1105 CL
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases