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

• ClinicalTrials.gov Identifier: NCT03761563
• Recruitment Status: Active, not recruiting
• First Posted: December 3, 2018
• Last Update Posted: August 12, 2021
• Sponsor: RTI Surgical
• Information provided by (Responsible Party): RTI Surgical

Study Description

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).

Study Design

• 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: December 30, 2022
• Estimated Study Completion Date: December 30, 2022

Groups and Cohorts

Intervention Details:

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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, California

Los Angeles Orthopedic Institute

Sherman Oaks, California, United States, 91403

United States, Colorado

Rocky Mountain Spine Clinic

Lone Tree, Colorado, United States, 80124

United States, District of Columbia

Medstar Georgetown University Hospital

Washington, District of Columbia, United States, 20007

United States, Florida

Florida Back Institute

Boca Raton, Florida, United States, 33496

South Florida Spine & Orthopaedics

Coconut Creek, Florida, United States, 33073

Spine Institute of South Florida

Delray Beach, Florida, United States, 33484

United States, Indiana

Indiana Spine Center

Indianapolis, Indiana, United States, 47905

United States, Kentucky

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, United States, 42001

United States, Maryland

OrthoBethesda

Bethesda, Maryland, United States, 20817

United States, Michigan

Vittorio M. Morreale, MD, PLC

Shelby, Michigan, United States, 48315

United States, New York

ReVive Spine Center

Niagara Falls, New York, United States, 14304

United States, Ohio

The Lindner Center for Research & Education at The Christ Hospital

Cincinnati, Ohio, United States, 45219

United States, Pennsylvania

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States, 19107

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States, 15212

United States, Texas

Spine MD

North Richland Hills, Texas, United States, 76182

Northwood Ortho-Spine

The Woodlands, Texas, United States, 77382

Sponsors and Collaborators

RTI Surgical

More Information

• Responsible Party: RTI Surgical
• ClinicalTrials.gov Identifier: NCT03761563
• Other Study ID Numbers: 1105 CL
• First Posted: December 3, 2018
• Last Update Posted: August 12, 2021
• Last Verified: August 2021

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

Additional relevant MeSH terms:

Spinal Diseases; Intervertebral Disc Degeneration; Bone Diseases; Musculoskeletal Diseases