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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fortilink IBF System with TETRAfuse Technology | Device | Cervical and lumbar fusion |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of cervical fusion evaluated by radiographic evidence | 12 months | |
| Rate of lumbar fusion evaluated by radiographic evidence | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Radiographic findings by CT evaluation |
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Inclusion Criteria:
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).
Exclusion Criteria:
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Subjects in this study will be candidates who undergo interbody fusion of hte spine due to degenerative disc disease using the Fortilink IBF device.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles Orthopedic Institute | Sherman Oaks | California | 91403 | United States | ||
| Rocky Mountain Spine Clinic |
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| 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 |
| 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 |
| 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 |
| Change in pain medication usage from baseline | 1 month, 3 months, 6 months, 12 months, and 24 months |
| Lone Tree |
| Colorado |
| 80124 |
| United States |
| Florida Back Institute | Boca Raton | Florida | 33496 | United States |
| South Florida Spine & Orthopaedics | Coconut Creek | Florida | 33073 | United States |
| Spine Institute of South Florida | Delray Beach | Florida | 33484 | United States |
| Indiana Spine Center | Indianapolis | Indiana | 47905 | United States |
| Orthopaedic Institute of Western Kentucky | Paducah | Kentucky | 42001 | United States |
| OrthoBethesda | Bethesda | Maryland | 20817 | United States |
| ReVive Spine Center | Niagara Falls | New York | 14304 | United States |
| The Lindner Center for Research & Education at The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Rothman Orthopaedic Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Spine MD | North Richland Hills | Texas | 76182 | United States |
| Northwood Ortho-Spine | The Woodlands | Texas | 77382 | United States |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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