FLXfitTM 15 TLIF Interbody Fusion Device

Study Overview
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Brief Summary
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The purpose of this study is post-market, patient outcome research to evaluate medical device safety and effectiveness. The data collected will assess the safety of the FLXfit 15TM (studydevice) system.

Detailed Description
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The purpose of this study is post-market, patient outcome research to evaluate medical device safety and effectiveness. The data collected will assess the safety of the FLXfit 15TM (study device) system, as measured by the rate of serious operative and post-operative complications. It will also assess the effectiveness as measured by radiographs (X-rays), CT scans, MRI scans, patient-reported, health-related quality of life questionnaires up to (24) months following the procedure, as compared to before surgery.

Official Title
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Post-market Surveillance Study of FLXfitTM 15 TLIF Interbody Fusion Device

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: FLXfit 15TM device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (18-70 y/o) Male or Female With the following conditions of the lumbar spine as confirmed by advanced imaging (CT or MRI), who is a candidate for primary spinal fusion procedure according to acceptable criteria for such medical conditions: Degenerative disc disease with up to Grade I spondylolisthesis Spondylolisthesis Failure of at least 6-months conservative treatment BMI < 40 Patient to approve no pregnancy during the 24 months of study and no participation in other studies in parallel to this one Ability to read, understand, and sign informed consent Exclusion Criteria: Infection, local to the operative site Signs of local inflammation Fever or leukocytosis Pregnancy Significant mental disorder or condition that could compromise the patient's ability to remember and comply with preoperative and postoperative instructions (e.g. current treatment for a psychiatric/psychosocial disorder, senile dementia, Alzheimer's disease, traumatic head injury) Prior surgical procedure (with the exception of decompression only procedure) at the index level(s) using the desired operative approach Prior fusion procedure at an adjacent level Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, fracture local to the operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care Active local infection in or near the operative region Active systemic infection and/or disease Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation Endocrine or metabolic disorders known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, hypothyroidism) Systemic disease that requires the chronic administration of nonsteroidal anti- inflammatory or steroidal drugs Suspected or documented allergy or intolerance to implant's materials Symptomatic cardiac disease Patient unwilling to cooperate with postoperative instructions. Any case where the implant components selected for use would be too large or too small to achieve a successful result. Patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance. Prior fusion at the level to be treated. Back VAS < 4/10

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FLXfit 15<br>The FLXfit 15 device will then be placed into the space between the low backbones, using specific medical instruments, where the damaged disc was removed. | Device: FLXfit 15TM device<br>* In order to implant the FLXfit 15TM device properly, your study doctor will first prepare the space between the low back bones (vertebrae) and then remove your damaged disc. The FLXfit 15TM device will then be placed into the space between the low backbones, using specific medical instruments, where the damaged disc was removed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion | Did patient achieve fusion? | through study completion; 2 year | 
| Visual Analogue Pain Scale: Back | 0 to 10 score; higher score means worse pain | 6-week | 
| Visual Analogue Pain Scale: Back | 0 to 10 score; higher score means worse pain | 12- week | 
| Visual Analogue Pain Scale: Back | 0 to 10 score; higher score means worse pain | 6-month | 
| Visual Analogue Pain Scale: Back | 0 to 10 score; higher score means worse pain | 1-year | 
| Visual Analogue Pain Scale: Back | 0 to 10 score; higher score means worse pain | 2-year | 
| Visual Analogue Pain Scale: Leg | 0 to 10 score; higher score means worse pain | 6-week | 
| Visual Analogue Pain Scale: Leg | 0 to 10 score; higher score means worse pain | 12- week | 
| Visual Analogue Pain Scale: Leg | 0 to 10 score; higher score means worse pain | 6-month | 
| Visual Analogue Pain Scale: Leg | 0 to 10 score; higher score means worse pain | 1-year | 
| Visual Analogue Pain Scale: Leg | 0 to 10 score; higher score means worse pain | 2-year | 
| Oswestry Disability Index | 0 to 100 score; higher score means greater patient disability | 6-week | 
| Oswestry Disability Index | 0 to 100 score; higher score means greater patient disability | 12- week | 
| Oswestry Disability Index | 0 to 100 score; higher score means greater patient disability | 6-month | 
| Oswestry Disability Index | 0 to 100 score; higher score means greater patient disability | 1-year | 
| Oswestry Disability Index | 0 to 100 score; higher score means greater patient disability | 2-year | 
| Short Form-12 Health Survey | 0 to 100 score; higher score means less patient disability | 6-week | 
| Short Form-12 Health Survey | 0 to 100 score; higher score means less patient disability | 12-week | 
| Short Form-12 Health Survey | 0 to 100 score; higher score means less patient disability | 6-month | 
| Short Form-12 Health Survey | 0 to 100 score; higher score means less patient disability | 1-year | 
| Short Form-12 Health Survey | 0 to 100 score; higher score means less patient disability | 2-year | 
| Patient Reported Outcomes Measurement Information System (PROMIS) | 20 to 80 score; higher score means higher reported self-capability | 6-week | 
| Patient Reported Outcomes Measurement Information System (PROMIS) | 20 to 80 score; higher score means higher reported self-capability | 12- week | 
| Patient Reported Outcomes Measurement Information System (PROMIS) | 20 to 80 score; higher score means higher reported self-capability | 6-month | 
| Patient Reported Outcomes Measurement Information System (PROMIS) | 20 to 80 score; higher score means higher reported self-capability | 1-year | 
| Patient Reported Outcomes Measurement Information System (PROMIS) | 20 to 80 score; higher score means higher reported self-capability | 2-year |