Clinical trial NCT04208048: FLXfitTM 15 TLIF Interbody Fusion Device
Official title: Post-market Surveillance Study of FLXfitTM 15 TLIF Interbody Fusion Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. Patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should be skeletally mature and have completed six months of non-operative treatment.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fusion
timeFrame: through study completion; 2 year
measure: Visual Analogue Pain Scale: Back
timeFrame: 6-week
measure: Visual Analogue Pain Scale: Back
timeFrame: 12- week
measure: Visual Analogue Pain Scale: Back
timeFrame: 6-month
measure: Visual Analogue Pain Scale: Back
timeFrame: 1-year
measure: Visual Analogue Pain Scale: Back
timeFrame: 2-year
measure: Visual Analogue Pain Scale: Leg
timeFrame: 6-week
measure: Visual Analogue Pain Scale: Leg
timeFrame: 12- week
measure: Visual Analogue Pain Scale: Leg
timeFrame: 6-month
measure: Visual Analogue Pain Scale: Leg
timeFrame: 1-year
measure: Visual Analogue Pain Scale: Leg
timeFrame: 2-year
measure: Oswestry Disability Index
timeFrame: 6-week
measure: Oswestry Disability Index
timeFrame: 12- week
measure: Oswestry Disability Index
timeFrame: 6-month
measure: Oswestry Disability Index
timeFrame: 1-year
measure: Oswestry Disability Index
timeFrame: 2-year
measure: Short Form-12 Health Survey
timeFrame: 6-week
measure: Short Form-12 Health Survey
timeFrame: 12-week
measure: Short Form-12 Health Survey
timeFrame: 6-month
measure: Short Form-12 Health Survey
timeFrame: 1-year
measure: Short Form-12 Health Survey
timeFrame: 2-year
measure: Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 6-week
measure: Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 12- week
measure: Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 6-month
measure: Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 1-year
measure: Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 2-year
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References: