FLXfitTM 15 TLIF Interbody Fusion Device

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Rush University Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Enrolling by invitation
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Degenerative Disc Disease
Additional Details

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.

Arms & Interventions


: FLXfit 15

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rush University Medical Center, Chicago, Illinois



Rush University Medical Center

Chicago, Illinois, 60612